Carcinoma, Non-Small-Cell Lung (NSCLC)NCT07538193
Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer
A study testing Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous) in people with Carcinoma, Non-Small-Cell Lung (NSCLC) and Neoplasm Staging, run by Tang-Du Hospital at 1 site in China.
Trial summary
Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung (NSCLC), Neoplasm Staging, Lymphatic Metastasis
- What is being tested?
- Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join the study and sign the Informed Consent Form (ICF).
- ≥18 years old, male or female.
- Histologically or cytologically confirmed T<sub>any</sub>N2b stage NSCLC (American Joint Committee on Cancer [AJCC] 9th edition). Lymph node status must be confirmed by endobronchial ultrasound (EBUS/EUS) or mediastinoscopy for mediastinal lymph nodes. For left-sided stations 5/6 lymph nodes, parasternal mediastinoscopy is recommended to confirm lymph node status; if mediastinoscopy is not performed, station 5/6 lymph node status is diagnosed based on imaging diagnostic criteria.
- Based on MDT assessment (which must include a thoracic surgeon specialized in oncology), the primary NSCLC is deemed to be completely resectable (R0).
- At least one measurable lesion as assessed by the investigator per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
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- Adequate organ function meeting the following requirements (no use of any blood components, cell growth factors, etc., within 14 days before the first dose):
- Absolute neutrophil count ≥1.5×10⁹/L;
- Platelet count ≥100×10⁹/L;
- Hemoglobin ≥90 g/L;
- Serum creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) ≥40 mL/min calculated by the Cockcroft-Gault formula;
- Total bilirubin ≤1.5×ULN (patients with Gilbert's syndrome may have ≤3×ULN);
- AST and ALT ≤3×ULN;
- International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy;
- Left ventricular ejection fraction (LVEF) ≥50%.
- For female patients of non-surgical sterilized or childbearing potential, must agree to use a medically accepted contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the study treatment period ends; female patients of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before the first dose; and must be non-lactating; for male patients with partners of childbearing potential, must agree to use effective contraception during the trial and for 3 months after the last dose of Iparomlimab/Tuvonralimab.
Who cannot join
- Known presence of EGFR or ALK positive mutations.
- History of or concurrent other malignancy within the past 5 years (excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery).
- Prior receipt of any anti-tumor therapy for the current lung cancer (e.g., radiotherapy, chemotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapies).
- Current use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continued use within 2 weeks before enrollment (Note: Inhaled or topical corticosteroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease).
- Any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism.
- Subjects with hypothyroidism controlled by hormone replacement therapy alone are eligible;
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- Subjects with skin diseases not requiring systemic treatment such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma that has completely resolved and requires no intervention in adulthood are eligible;
- Patients with asthma requiring medical intervention with steroids are not eligible.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).
- Congenital or acquired immunodeficiency (e.g., HIV-infected individuals).
- Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] test at screening with concurrent HBV-DNA test value above the upper limit of normal of the research center's laboratory; subjects with HBV-DNA <500 IU/mL measured within 28 days before study drug administration and who have received standard local antiviral therapy for at least 4 weeks and are willing to continue antiviral therapy during the study may be enrolled). Subjects with active hepatitis C (defined as positive hepatitis C virus antibody [HCsAb] test at screening and positive HCV-RNA).
- History of severe allergic reactions to other monoclonal antibodies.
- Vaccination with live vaccine within 30 days before the first dose of study treatment (continuing until 90 days after the last dose of study treatment). Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Inactivated seasonal influenza vaccines, inactivated COVID-19 vaccines, etc., are permitted.
- Clinically significant cardiovascular or cerebrovascular diseases, including but not limited to:
- Myocardial infarction or unstable angina pectoris within 6 months before the first dose;
- Stroke or transient ischemic attack within 6 months before the first dose;
- Hypertension not controlled with optimal antihypertensive therapy (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Clinically significant arrhythmia that has been stable for ≥14 days before the first dose may be enrolled;
- Congestive heart failure (New York Heart Association [NYHA] functional class III-IV);
- Myocarditis.
- Systemic infection or other severe infection requiring intravenous antibiotics for >7 days within 2 weeks before the first study treatment, or unexplained fever >38.5°C during screening or before enrollment (fever due to tumor causes as judged by the investigator is excluded).
- Any other condition that, in the investigator's judgment, might affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors, which could affect patient safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of Iparomlimab and Tuvonralimab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Stage III-N2b Non-Small Cell Lung Cancer
Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity.
Objective: This phase II, single-arm, multicenter study aims to evaluate the efficacy and safety of neoadjuvant iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy in patients with resectable stage III-N2b NSCLC.
Read more
Study Design and Methods: A total of 28 patients will be enrolled across approximately 4 centers in China. Eligible patients (aged ≥18 years, ECOG PS 0-1) with histologically or cytologically confirmed, resectable stage III-N2b NSCLC (AJCC 9th edition) will receive three cycles of neoadjuvant therapy every three weeks. Patients with non-squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus pemetrexed (500 mg/m²) and carboplatin (AUC 5). Patients with squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus nab-paclitaxel (260 mg/m²) and carboplatin (AUC 5). Surgical resection will be performed within 6 weeks following completion of neoadjuvant therapy. Subsequent adjuvant treatment is at the discretion of the investigator.
Key Eligibility Criteria: Key inclusion criteria include pathologically confirmed T<sub>any</sub>N2b disease with mediastinal nodal status confirmed by EBUS/EUS or mediastinoscopy, and the determination by multidisciplinary team (MDT) assessment that the tumor is completely resectable (R0). Key exclusion criteria include known EGFR or ALK positive mutations, prior anti-cancer therapy for current lung cancer, active autoimmune disease, or uncontrolled hepatitis B or C.
Study Endpoints: The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), impact on surgical outcomes, and safety. Exploratory endpoints involve biomarker analysis including ctDNA.
Sample Size Rationale: Assuming a null hypothesis pCR rate (P0) of 8.8% (based on historical data) and an expected pCR rate (P1) of 28%, with a two-sided α of 5% and 80% power, 24 patients are required. Factoring in a 15% inoperable rate, the total sample size is 28 patients.
Statistical Analysis: The primary endpoint, pCR rate, and other binary endpoints will be summarized with frequencies, percentages, and their 95% confidence intervals calculated using the Clopper-Pearson method. Time-to-event endpoints (EFS, OS) will be analyzed using the Kaplan-Meier method. Safety data will be summarized descriptively.
Clinical Trial Information: This study is sponsored by The Second Affiliated Hospital of Air Force Medical University, PLA. The Principal Investigator is Dr. Yan Xiaolong.
Read the detailed description
As of September 20, 2024, a total of 16 clinical studies of the Iparomlimab/Tuvonralimab combination antibody had been initiated (see Investigator's Brochure for details). A total of 1,160 subjects had received treatment with the combination antibody, of whom 766 received monotherapy and 394 received combination therapy.
The safety profile of the Iparomlimab/Tuvonralimab combination antibody is consistent with its therapeutic class, with a relatively low incidence of treatment-related Grade 3 or higher toxicities. In monotherapy studies, more than half of the patients experienced treatment-emergent adverse events related to the combination antibody (77.5%), but the incidence of ≥Grade 3 events related to the combination antibody was low (25.4%). Any-grade immune-related adverse events (irAEs) were reported in 47.6% of patients; these were primarily low-grade, resolved after treatment, and considered manageable, with a ≥Grade 3 incidence of 11.9%. In studies of the combination antibody combined with chemotherapy, the AE profile was consistent with the established AE profiles of currently available immune checkpoint inhibitors and standard chemotherapy drugs. Based on the current safety information for the Iparomlimab/Tuvonralimab combination antibody, the safety profile of the investigational drug is considered generally consistent with that exhibited by currently marketed major PD-1 and CTLA-4 immune checkpoint inhibitors, with no unexpected serious safety risks observed. The investigational drug demonstrates a favorable safety and tolerability profile.
Four studies have been initiated independently in the lung cancer field, all with protocols involving combination with chemotherapy.
The DUBHE-L-201/QL1706-201 study is a single-arm, non-randomized, open-label, single-center Phase II clinical study evaluating the safety and efficacy of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy ± bevacizumab as first-line treatment for advanced non-small cell lung cancer. The study was divided into five cohorts. Cohorts 1-4 focused on first-line treatment for stage IIIB-IV NSCLC without EGFR/ALK alterations: Cohort 1 enrolled 17 patients with squamous carcinoma, treated with the combination antibody combined with paclitaxel and carboplatin Q3W for 2 cycles, followed by maintenance with the combination antibody; Cohort 2 enrolled 11 patients with squamous carcinoma, treated with the combination antibody combined with paclitaxel and carboplatin Q3W for 4 cycles, followed by maintenance with the combination antibody; Cohort 3 enrolled 12 patients with non-squamous carcinoma, treated with the combination antibody combined with pemetrexed and carboplatin Q3W for 2 cycles, followed by maintenance with the combination antibody; Cohort 4 enrolled 20 patients with non-squamous carcinoma, treated with the combination antibody combined with pemetrexed, carboplatin, and bevacizumab Q3W for 4 cycles, followed by maintenance with the combination antibody, pemetrexed, and bevacizumab. Cohort 5 enrolled 31 patients with non-squamous carcinoma harboring EGFR-sensitive mutations who had progressed on EGFR-TKI therapy, treated with the combination antibody combined with pemetrexed, carboplatin, and bevacizumab Q3W for 4 cycles, followed by maintenance with the combination antibody, pemetrexed, and bevacizumab. The incidence of TRAEs leading to discontinuation was 8.3% in first-line cohorts 1-4 and 3.2% in the EGFR-TKI resistant cohort 5. In first-line treatment, the ORR was 45.0%, median PFS was 6.8 months, the incidence of ≥Grade 3 TRAEs was 31.7%, TRSAE incidence was 25.0%, the incidence of TRAEs leading to dose interruption was 63.3%, the incidence leading to study discontinuation was 8.3%, and no TRAEs led to death. In the EGFR-TKI resistant cohort 5, the ORR was 54.8%, median PFS was 8.5 months, and median OS was 26.5 months.
The DUBHE-L-209/QL1706-209 study is a single-arm, multicenter Phase II clinical study of the Iparomlimab/Tuvonralimab combination antibody combined with carboplatin and etoposide as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), designed to evaluate safety, tolerability, efficacy, PK characteristics, and immunogenicity. The study enrolled a total of 40 patients with untreated ES-SCLC. During the intensive treatment phase, patients received the combination antibody combined with carboplatin and etoposide Q3W for 4-6 cycles, followed by maintenance with the combination antibody alone. The incidence of ≥Grade 3 TEAEs was 90%, SAE incidence was 50%, irAE incidence was 15%, TEAEs leading to death occurred in 5%, and no TRAEs led to discontinuation or death. The ORR was 89.7%, and median PFS was 5.7 months.
The DUBHE-L-303/QL1706-303 study (NCT05690945 / CTR20223309) is a randomized, double-blind, active-controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy versus tislelizumab combined with chemotherapy in patients with PD-L1 negative, driver gene-negative locally advanced or metastatic NSCLC. The study plans to enroll 650 subjects, randomized 1:1 into two groups. The study includes a screening period (≤28 days from ICF signing to first dose), a treatment period (subjects receive study treatment until end of treatment), and a follow-up period (including safety follow-up and survival follow-up). Subjects will receive the following regimens until disease progression, intolerable toxicity, withdrawal of consent, non-compliance, investigator decision to withdraw, or other protocol-specified reasons (Iparomlimab/Tuvonralimab combination antibody/tislelizumab treatment for a maximum of 2 years [35 cycles]). Experimental Group: Iparomlimab/Tuvonralimab combination antibody + pemetrexed + carboplatin (non-squamous), or Iparomlimab/Tuvonralimab combination antibody + paclitaxel + carboplatin (squamous), for 4 cycles, then enter maintenance phase, continuing with Iparomlimab/Tuvonralimab combination antibody + pemetrexed (non-squamous) or Iparomlimab/Tuvonralimab combination antibody alone (squamous). Control Group: Tislelizumab + pemetrexed + carboplatin (non-squamous), or tislelizumab + paclitaxel + carboplatin (squamous), for 4 cycles, then enter maintenance phase, continuing with tislelizumab + pemetrexed (non-squamous) or tislelizumab alone (squamous).
The DUBHE-L-304/QL1706-304 study (NCT05487391/CTR20222281) is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study evaluating the safety and efficacy of the Iparomlimab/Tuvonralimab combination antibody combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy as adjuvant therapy in patients with completely resected stage I-IIIB NSCLC without EGFR-sensitive mutations and ALK fusion genes. This study randomizes subjects 1:1 into two groups, with approximately 316 subjects in each group (experimental and control). Subjects will receive either the Iparomlimab/Tuvonralimab combination antibody or placebo, concurrently with adjuvant chemotherapy for 2-4 cycles. The Iparomlimab/Tuvonralimab combination antibody or placebo will be administered for 16 cycles, unless: disease recurrence; intolerable adverse events; intercurrent illness preventing continued treatment; investigator decision to withdraw subject; subject withdrawal of consent; subject pregnancy; non-compliance with trial treatment or procedures; other administrative reasons.
In summary, based on relevant study results, perioperative immunotherapy can significantly improve EFS and pCR in patients with N2 stage disease without increasing surgical difficulty, providing a new treatment option for patients with resectable NSCLC, especially those with poorer prognosis stage III-N2 disease. Therefore, this study protocol aims to explore the efficacy and safety of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy in the perioperative treatment of resectable stage III-N2b NSCLC, with the expectation of exploring a more effective and safer new perioperative immunotherapy regimen.
- Being tested
- Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)Drug
Participants receive neoadjuvant treatment with Iparomlimab and Tuvonralimab in combination with platinum-based chemotherapy for three cycles prior to surgical resection.
Dosing Regimen:
For Non-squamous Carcinoma:
Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Pemetrexed: 500 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles
For Squamous Carcinoma:
Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Nab-paclitaxel: 260 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles After completion of neoadjuvant therapy, participants undergo surgical resection within 6 weeks. Adjuvant treatment following surgery is administered at the discretion of the investigator and is not specified by this protocol.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab plus Chemotherapy | Experimental | Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous) Receives: Drug: Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) rate
The percentage of subjects with no residual viable tumor cells in the resected primary tumor bed and lymph nodes after lung cancer resection.
Measured: At the time of surgery, approximately 9-15 weeks after enrollment
Secondary outcomes (11)
Major Pathological Response (MPR) rate
The percentage of subjects with ≤10% residual viable tumor cells in the resected primary tumor bed and lymph nodes after lung cancer resection.
Measured: At the time of surgery, approximately 9-15 weeks after enrollment
Objective Response Rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) on imaging according to RECIST v1.1 criteria prior to surgery.
Measured: From enrollment to pre-surgery assessment, approximately 9-15 weeks
R0 Resection Rate
The percentage of subjects undergoing lung cancer resection who achieve complete resection with negative margins.
Measured: At the time of surgery
Event-Free Survival (EFS)
Defined as the time from first study drug administration to the occurrence of disease progression precluding surgery, local or distant recurrence, or death from any cause.
Measured: From enrollment to up to 2 years post-surgery
Overall Survival (OS)
Defined as the time from first study drug administration to death from any cause.
Measured: From enrollment to up to 2 years post-surgery or death
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to NCI-CTCAE v5.0; rates of dose interruptions, modifications, and discontinuations due to AEs.
Measured: From first dose to 90 days after last dose
Rate of Delayed or Cancelled Surgery
The percentage of subjects whose planned surgery is delayed beyond the protocol-specified window or cancelled.
Measured: From completion of neoadjuvant therapy to scheduled surgery date, approximately 6 weeks
Surgery Duration
The total time from surgical incision to closure, measured in minutes.
Measured: At the time of surgery
Hospitalization Duration
The total number of days from surgery to hospital discharge.
Measured: From surgery date to hospital discharge, approximately 1-4 weeks
Surgical Method
The type of surgical procedure performed (e.g., lobectomy, pneumonectomy, sleeve resection, etc.) and surgical approach (e.g., open thoracotomy, video-assisted thoracoscopic surgery [VATS]).
Measured: At the time of surgery
Incidence of Surgery-Related Adverse Events
The incidence and severity of surgery-related adverse events, including intraoperative complications (e.g., pneumonia, respiratory distress syndrome, packed red blood cell transfusion, bronchopleural fistula, air leak), readmission to intensive care unit, atrial fibrillation, and other supraventricular tachycardia (SVT).
Measured: From surgery to 90 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell Lung (NSCLC)Studies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538193
- Sponsor's protocol ID
- K202511-27
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.
PubMed 37379158Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926.
PubMed 38749033Provencio M, Awad MM, Spicer JD, Janssens A, Moiseyenko F, Gao Y, Watanabe Y, Alexandru A, Guisier F, Frost N, Franke F, Hiltermann TJN, He J, Tanaka F, Lu S, Coronado Erdmann C, Sathyanarayana P, Tran P, Devas V, Cascone T. Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis. Nat Cancer. 2026 Jan;7(1):169-181. doi: 10.1038/s43018-025-01104-z. Epub 2026 Jan 8.
PubMed 41507539Zhao Y, Wang W, Liang H, Yang CJ, D'Amico T, Ng CSH, Liu CC, Petersen RH, Rocco G, Brunelli A, Liu J, He J, Huang W, Liang W, He J; AME Thoracic Surgery Collaborative Group. The Optimal Treatment for Stage IIIA-N2 Non-Small Cell Lung Cancer: A Network Meta-Analysis. Ann Thorac Surg. 2019 Jun;107(6):1866-1875. doi: 10.1016/j.athoracsur.2018.11.024. Epub 2018 Dec 14.
PubMed 30557543Carter L, Apte V, Shukla A, Ghose A, Mamidi R, Petohazi A, Makker S, Banerjee S, Boussios S, Banna GL. Stage 3 N2 Lung Cancer: A Multidisciplinary Therapeutic Conundrum. Curr Oncol Rep. 2024 Jan;26(1):65-79. doi: 10.1007/s11912-023-01486-2. Epub 2024 Jan 2.
PubMed 38180692Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
PubMed 39036382
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Iparomlimab and Tuvonralimab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Stage III-N2b Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07538193
- Acronym / sponsor ID
- K202511-27
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity.
Objective: This phase II, single-arm, multicenter study aims to evaluate the efficacy and safety of neoadjuvant iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy in patients with resectable stage III-N2b NSCLC.
Study Design and Methods: A total of 28 patients will be enrolled across approximately 4 centers in China. Eligible patients (aged ≥18 years, ECOG PS 0-1) with histologically or cytologically confirmed, resectable stage III-N2b NSCLC (AJCC 9th edition) will receive three cycles of neoadjuvant therapy every three weeks. Patients with non-squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus pemetrexed (500 mg/m²) and carboplatin (AUC 5). Patients with squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg/kg) plus nab-paclitaxel (260 mg/m²) and carboplatin (AUC 5). Surgical resection will be performed within 6 weeks following completion of neoadjuvant therapy. Subsequent adjuvant treatment is at the discretion of the investigator.
Key Eligibility Criteria: Key inclusion criteria include pathologically confirmed T<sub>any</sub>N2b disease with mediastinal nodal status confirmed by EBUS/EUS or mediastinoscopy, and the determination by multidisciplinary team (MDT) assessment that the tumor is completely resectable (R0). Key exclusion criteria include known EGFR or ALK positive mutations, prior anti-cancer therapy for current lung cancer, active autoimmune disease, or uncontrolled hepatitis B or C.
Study Endpoints: The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), impact on surgical outcomes, and safety. Exploratory endpoints involve biomarker analysis including ctDNA.
Sample Size Rationale: Assuming a null hypothesis pCR rate (P0) of 8.8% (based on historical data) and an expected pCR rate (P1) of 28%, with a two-sided α of 5% and 80% power, 24 patients are required. Factoring in a 15% inoperable rate, the total sample size is 28 patients.
Statistical Analysis: The primary endpoint, pCR rate, and other binary endpoints will be summarized with frequencies, percentages, and their 95% confidence intervals calculated using the Clopper-Pearson method. Time-to-event endpoints (EFS, OS) will be analyzed using the Kaplan-Meier method. Safety data will be summarized descriptively.
Clinical Trial Information: This study is sponsored by The Second Affiliated Hospital of Air Force Medical University, PLA. The Principal Investigator is Dr. Yan Xiaolong.
Detailed description
As of September 20, 2024, a total of 16 clinical studies of the Iparomlimab/Tuvonralimab combination antibody had been initiated (see Investigator's Brochure for details). A total of 1,160 subjects had received treatment with the combination antibody, of whom 766 received monotherapy and 394 received combination therapy.
The safety profile of the Iparomlimab/Tuvonralimab combination antibody is consistent with its therapeutic class, with a relatively low incidence of treatment-related Grade 3 or higher toxicities. In monotherapy studies, more than half of the patients experienced treatment-emergent adverse events related to the combination antibody (77.5%), but the incidence of ≥Grade 3 events related to the combination antibody was low (25.4%). Any-grade immune-related adverse events (irAEs) were reported in 47.6% of patients; these were primarily low-grade, resolved after treatment, and considered manageable, with a ≥Grade 3 incidence of 11.9%. In studies of the combination antibody combined with chemotherapy, the AE profile was consistent with the established AE profiles of currently available immune checkpoint inhibitors and standard chemotherapy drugs. Based on the current safety information for the Iparomlimab/Tuvonralimab combination antibody, the safety profile of the investigational drug is considered generally consistent with that exhibited by currently marketed major PD-1 and CTLA-4 immune checkpoint inhibitors, with no unexpected serious safety risks observed. The investigational drug demonstrates a favorable safety and tolerability profile.
Four studies have been initiated independently in the lung cancer field, all with protocols involving combination with chemotherapy.
The DUBHE-L-201/QL1706-201 study is a single-arm, non-randomized, open-label, single-center Phase II clinical study evaluating the safety and efficacy of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy ± bevacizumab as first-line treatment for advanced non-small cell lung cancer. The study was divided into five cohorts. Cohorts 1-4 focused on first-line treatment for stage IIIB-IV NSCLC without EGFR/ALK alterations: Cohort 1 enrolled 17 patients with squamous carcinoma, treated with the combination antibody combined with paclitaxel and carboplatin Q3W for 2 cycles, followed by maintenance with the combination antibody; Cohort 2 enrolled 11 patients with squamous carcinoma, treated with the combination antibody combined with paclitaxel and carboplatin Q3W for 4 cycles, followed by maintenance with the combination antibody; Cohort 3 enrolled 12 patients with non-squamous carcinoma, treated with the combination antibody combined with pemetrexed and carboplatin Q3W for 2 cycles, followed by maintenance with the combination antibody; Cohort 4 enrolled 20 patients with non-squamous carcinoma, treated with the combination antibody combined with pemetrexed, carboplatin, and bevacizumab Q3W for 4 cycles, followed by maintenance with the combination antibody, pemetrexed, and bevacizumab. Cohort 5 enrolled 31 patients with non-squamous carcinoma harboring EGFR-sensitive mutations who had progressed on EGFR-TKI therapy, treated with the combination antibody combined with pemetrexed, carboplatin, and bevacizumab Q3W for 4 cycles, followed by maintenance with the combination antibody, pemetrexed, and bevacizumab. The incidence of TRAEs leading to discontinuation was 8.3% in first-line cohorts 1-4 and 3.2% in the EGFR-TKI resistant cohort 5. In first-line treatment, the ORR was 45.0%, median PFS was 6.8 months, the incidence of ≥Grade 3 TRAEs was 31.7%, TRSAE incidence was 25.0%, the incidence of TRAEs leading to dose interruption was 63.3%, the incidence leading to study discontinuation was 8.3%, and no TRAEs led to death. In the EGFR-TKI resistant cohort 5, the ORR was 54.8%, median PFS was 8.5 months, and median OS was 26.5 months.
The DUBHE-L-209/QL1706-209 study is a single-arm, multicenter Phase II clinical study of the Iparomlimab/Tuvonralimab combination antibody combined with carboplatin and etoposide as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), designed to evaluate safety, tolerability, efficacy, PK characteristics, and immunogenicity. The study enrolled a total of 40 patients with untreated ES-SCLC. During the intensive treatment phase, patients received the combination antibody combined with carboplatin and etoposide Q3W for 4-6 cycles, followed by maintenance with the combination antibody alone. The incidence of ≥Grade 3 TEAEs was 90%, SAE incidence was 50%, irAE incidence was 15%, TEAEs leading to death occurred in 5%, and no TRAEs led to discontinuation or death. The ORR was 89.7%, and median PFS was 5.7 months.
The DUBHE-L-303/QL1706-303 study (NCT05690945 / CTR20223309) is a randomized, double-blind, active-controlled, multicenter Phase III clinical study designed to evaluate the efficacy and safety of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy versus tislelizumab combined with chemotherapy in patients with PD-L1 negative, driver gene-negative locally advanced or metastatic NSCLC. The study plans to enroll 650 subjects, randomized 1:1 into two groups. The study includes a screening period (≤28 days from ICF signing to first dose), a treatment period (subjects receive study treatment until end of treatment), and a follow-up period (including safety follow-up and survival follow-up). Subjects will receive the following regimens until disease progression, intolerable toxicity, withdrawal of consent, non-compliance, investigator decision to withdraw, or other protocol-specified reasons (Iparomlimab/Tuvonralimab combination antibody/tislelizumab treatment for a maximum of 2 years [35 cycles]). Experimental Group: Iparomlimab/Tuvonralimab combination antibody + pemetrexed + carboplatin (non-squamous), or Iparomlimab/Tuvonralimab combination antibody + paclitaxel + carboplatin (squamous), for 4 cycles, then enter maintenance phase, continuing with Iparomlimab/Tuvonralimab combination antibody + pemetrexed (non-squamous) or Iparomlimab/Tuvonralimab combination antibody alone (squamous). Control Group: Tislelizumab + pemetrexed + carboplatin (non-squamous), or tislelizumab + paclitaxel + carboplatin (squamous), for 4 cycles, then enter maintenance phase, continuing with tislelizumab + pemetrexed (non-squamous) or tislelizumab alone (squamous).
The DUBHE-L-304/QL1706-304 study (NCT05487391/CTR20222281) is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical study evaluating the safety and efficacy of the Iparomlimab/Tuvonralimab combination antibody combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy as adjuvant therapy in patients with completely resected stage I-IIIB NSCLC without EGFR-sensitive mutations and ALK fusion genes. This study randomizes subjects 1:1 into two groups, with approximately 316 subjects in each group (experimental and control). Subjects will receive either the Iparomlimab/Tuvonralimab combination antibody or placebo, concurrently with adjuvant chemotherapy for 2-4 cycles. The Iparomlimab/Tuvonralimab combination antibody or placebo will be administered for 16 cycles, unless: disease recurrence; intolerable adverse events; intercurrent illness preventing continued treatment; investigator decision to withdraw subject; subject withdrawal of consent; subject pregnancy; non-compliance with trial treatment or procedures; other administrative reasons.
In summary, based on relevant study results, perioperative immunotherapy can significantly improve EFS and pCR in patients with N2 stage disease without increasing surgical difficulty, providing a new treatment option for patients with resectable NSCLC, especially those with poorer prognosis stage III-N2 disease. Therefore, this study protocol aims to explore the efficacy and safety of the Iparomlimab/Tuvonralimab combination antibody combined with chemotherapy in the perioperative treatment of resectable stage III-N2b NSCLC, with the expectation of exploring a more effective and safer new perioperative immunotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab plus Chemotherapy | Experimental | Drug: Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntarily join the study and sign the Informed Consent Form (ICF).
- ≥18 years old, male or female.
- Histologically or cytologically confirmed T<sub>any</sub>N2b stage NSCLC (American Joint Committee on Cancer [AJCC] 9th edition). Lymph node status must be confirmed by endobronchial ultrasound (EBUS/EUS) or mediastinoscopy for mediastinal lymph nodes. For left-sided stations 5/6 lymph nodes, parasternal mediastinoscopy is recommended to confirm lymph node status; if mediastinoscopy is not performed, station 5/6 lymph node status is diagnosed based on imaging diagnostic criteria.
- Based on MDT assessment (which must include a thoracic surgeon specialized in oncology), the primary NSCLC is deemed to be completely resectable (R0).
- At least one measurable lesion as assessed by the investigator per RECIST v1.1.
Key exclusion criteria (22 listed)
- Known presence of EGFR or ALK positive mutations.
- History of or concurrent other malignancy within the past 5 years (excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery).
- Prior receipt of any anti-tumor therapy for the current lung cancer (e.g., radiotherapy, chemotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapies).
- Current use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continued use within 2 weeks before enrollment (Note: Inhaled or topical corticosteroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease).
- Any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous)Participants receive neoadjuvant treatment with Iparomlimab and Tuvonralimab in combination with platinum-based chemotherapy for three cycles prior to surgical resection. Dosing Regimen: For Non-squamous Carcinoma: Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Pemetrexed: 500 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles For Squamous Carcinoma: Iparomlimab and Tuvonralimab: 5 mg/kg, intravenous infusion, Day 1 Nab-paclitaxel: 260 mg/m², intravenous infusion, Day 1 Carboplatin: AUC 5, intravenous infusion, Day 1 Cycle length: 21 days (every 3 weeks) Total treatment: 3 cycles After completion of neoadjuvant therapy, participants undergo surgical resection within 6 weeks. Adjuvant treatment following surgery is administered at the discretion of the investigator and is not specified by this protocol. | Drug | Iparomlimab and Tuvonralimab plus Chemotherapy |
Primary outcome
Pathological Complete Response (pCR) rate
Time frame: At the time of surgery, approximately 9-15 weeks after enrollment
The percentage of subjects with no residual viable tumor cells in the resected primary tumor bed and lymph nodes after lung cancer resection.
11 secondary outcomes
Major Pathological Response (MPR) rate
Time frame: At the time of surgery, approximately 9-15 weeks after enrollment
Objective Response Rate (ORR)
Time frame: From enrollment to pre-surgery assessment, approximately 9-15 weeks
R0 Resection Rate
Time frame: At the time of surgery
Event-Free Survival (EFS)
Time frame: From enrollment to up to 2 years post-surgery
Overall Survival (OS)
Time frame: From enrollment to up to 2 years post-surgery or death
Safety and Tolerability
Time frame: From first dose to 90 days after last dose
Rate of Delayed or Cancelled Surgery
Time frame: From completion of neoadjuvant therapy to scheduled surgery date, approximately 6 weeks
Surgery Duration
Time frame: At the time of surgery
Hospitalization Duration
Time frame: From surgery date to hospital discharge, approximately 1-4 weeks
Surgical Method
Time frame: At the time of surgery
Incidence of Surgery-Related Adverse Events
Time frame: From surgery to 90 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 37379158Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.
- Background: PubMed 38749033Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926.
- Background: PubMed 41507539Provencio M, Awad MM, Spicer JD, Janssens A, Moiseyenko F, Gao Y, Watanabe Y, Alexandru A, Guisier F, Frost N, Franke F, Hiltermann TJN, He J, Tanaka F, Lu S, Coronado Erdmann C, Sathyanarayana P, Tran P, Devas V, Cascone T. Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis. Nat Cancer. 2026 Jan;7(1):169-181. doi: 10.1038/s43018-025-01104-z. Epub 2026 Jan 8.
- Background: PubMed 30557543Zhao Y, Wang W, Liang H, Yang CJ, D'Amico T, Ng CSH, Liu CC, Petersen RH, Rocco G, Brunelli A, Liu J, He J, Huang W, Liang W, He J; AME Thoracic Surgery Collaborative Group. The Optimal Treatment for Stage IIIA-N2 Non-Small Cell Lung Cancer: A Network Meta-Analysis. Ann Thorac Surg. 2019 Jun;107(6):1866-1875. doi: 10.1016/j.athoracsur.2018.11.024. Epub 2018 Dec 14.
- Background: PubMed 38180692Carter L, Apte V, Shukla A, Ghose A, Mamidi R, Petohazi A, Makker S, Banerjee S, Boussios S, Banna GL. Stage 3 N2 Lung Cancer: A Multidisciplinary Therapeutic Conundrum. Curr Oncol Rep. 2024 Jan;26(1):65-79. doi: 10.1007/s11912-023-01486-2. Epub 2024 Jan 2.
- Background: PubMed 39036382Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iparomlimab and Tuvonralimab combined with Platinum-Based Chemotherapy (Pemetrexed/Carboplatin for Non-squamous; Nab-paclitaxel/Carboplatin for Squamous) in people with Carcinoma, Non-Small-Cell Lung (NSCLC) and Neoplasm Staging, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XiaoLong Yan, Doctor of Medicine(M.D.) (+8615991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) rate (time frame: At the time of surgery, approximately 9-15 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07538193, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.