Non-Small Cell Lung CancerPhase 2NCT07775040
Spatially Fractionated Radiotherapy With Tislelizumab and Chemotherapy for Bulky Stage III NSCLC: A Phase II Trial
A Phase 2 study testing Spatially Fractionated Radiotherapy (SFRT), Tislelizumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This is a prospective, single-arm, multicenter phase II clinical study evaluating the efficacy and safety of spatially fractionated radiotherapy (SFRT) combined with tislelizumab and platinum-based doublet chemotherapy as induction/conversion therapy for patients with potentially resectable stage III non-small cell… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Spatially Fractionated Radiotherapy (SFRT), Tislelizumab and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 30 Jun 2030
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary agreement to participate and signed written informed consent.
- Cytologically or histologically confirmed (via percutaneous lung biopsy, bronchoscopy, mediastinoscopy, etc.) bulky stage III non-small cell lung cancer (NSCLC) per AJCC 9th edition staging, with primary tumor >5 cm (T3-T4), N0-N2, and no prior chemotherapy, radiotherapy, surgery, or immunotherapy.
- Pulmonary lesion considered potentially resectable by a multidisciplinary team (MDT) including a thoracic surgeon.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Adequate hematologic and organ function as demonstrated by:
- Absolute neutrophil count ≥ 1,500 × 10⁹/L.
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- Platelet count ≥ 100 × 10⁹/L.
- Hemoglobin > 9.0 g/dL.
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min.
- AST/ALT ≤ 3 × ULN.
- Total bilirubin ≤ 1.5 × ULN.
- FEV1 ≥ 1.2 L or > 40% of predicted value.
- INR/APTT within normal limits.
- -Age 18 to 75 years (inclusive).
Who cannot join
- Has or is suspected of having an autoimmune disease. Note: patients with vitiligo, type I diabetes mellitus, or hypothyroidism (Hashimoto's thyroiditis) requiring only hormone replacement therapy may be enrolled if no significant signs of recurrence are present.
- Requires systemic corticosteroid therapy (>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10 mg prednisone or equivalent per day) for patients without active autoimmune disease, are permitted.
- Prior history of thoracic radiotherapy.
- Active bleeding prior to treatment.
- Severe cardiac, pulmonary, hepatic, renal, or hematopoietic dysfunction, cachexia, or any condition that would preclude tolerance to radiochemotherapy.
- History of diabetes mellitus for >10 years with poorly controlled blood glucose.
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- History of interstitial lung disease or non-infectious pneumonitis.
- NSCLC with known EGFR-sensitizing mutations, ALK fusion gene, or ROS1 rearrangement.
- History of another malignancy (excluding non-melanoma skin cancer and carcinoma in situ of the bladder, stomach, colon, endometrium, cervix, melanoma, or breast) unless the malignancy has been in complete remission for ≥2 years and no additional anti-tumor therapy is required during the study period.
- In the investigator's opinion, medically, psychologically, or physically unable to complete the study or to understand the patient information.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other agents targeting T-cell co-stimulation or immune checkpoint pathways.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL) or hepatitis C (anti-HCV antibody positive and HCV-RNA above the lower limit of detection).
- HIV-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).
- Known or suspected allergy to the study drugs or to any agent used in this trial.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
peng xu, PhD contact
China1 site
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
bin hu, 028-85420367, hubin@sczlyy.org.cn
About this study
Official title: A Prospective, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Tislelizumab and Platinum-based Doublet Chemotherapy as Induction/Conversion Therapy for Potentially Resectable Stage III Non-small Cell Lung Cancer With Bulky Disease.
This is a prospective, single-arm, multicenter phase II clinical study evaluating the efficacy and safety of spatially fractionated radiotherapy (SFRT) combined with tislelizumab and platinum-based doublet chemotherapy as induction/conversion therapy for patients with potentially resectable stage III non-small cell lung cancer (NSCLC) with bulky disease (primary tumor >5 cm).
SFRT, also known as lattice radiation therapy, is a novel radiotherapy technique that creates alternating high-dose and low-dose regions within the tumor. This approach not only reduces tumor burden but also may enhance anti-tumor immune responses, potentially working synergistically with immunotherapy.
Read more
Study participants will receive SFRT to the primary lung tumor (GTV 20 Gy/5 fractions, GTV-Lattice 60 Gy/5 fractions), followed by 2-4 cycles of tislelizumab (200 mg, Q3W) combined with platinum-based doublet chemotherapy. Surgery will be performed 4-6 weeks after the last cycle of neoadjuvant therapy. The first 6 enrolled patients will undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drug.
The primary endpoint is major pathological response (MPR) rate, defined as the proportion of patients with ≤10% viable tumor cells in the resected specimen. Secondary endpoints include 1-year event-free survival (EFS), pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), R0 resection rate, 1-year overall survival (OS), time to distant metastasis (TTDM), and safety.
A total of 44 patients will be enrolled across multiple centers in China. An interim analysis will be conducted after 50% of patients are enrolled.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Spatially Fractionated Radiotherapy (SFRT), Tislelizumab, Carboplatin, Cisplatin, Pemetrexed
- Keywords
- Non-Small Cell Lung Cancer (Stage III, Bulky Disease, Potentially Resectable)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiotherapy (SFRT)Radiation
Participants receive lattice radiation therapy to the primary lung tumor. The gross tumor volume (GTV) is delineated, and lattice target volumes (GTV-Lattice) are generated using a hexagonal close-packed model within the tumor. Volumetric modulated arc therapy (VMAT) plans are designed. Prescription dose: GTV receives 20 Gy in 5 fractions, and GTV-Lattice receives 60 Gy in 5 fractions. After plan verification, treatment is delivered on 3 non-consecutive working days (e.g., Monday, Wednesday, Friday).
TislelizumabDrug
200 mg administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles, starting on Day 8-15 following SFRT.
CarboplatinDrug
AUC 5 administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion.
CisplatinDrug
75 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion. Adequate hydration and antiemetic prophylaxis are required.
PemetrexedDrug
500 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with non-squamous NSCLC. Vitamin B12 and folic acid supplementation are required per standard practice.
PaclitaxelDrug
175 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with squamous NSCLC. Premedication to prevent hypersensitivity is required per standard practice.
Radical Lung Resection SurgeryProcedure or surgery
Definitive radical surgery is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. Surgical approaches include minimally invasive techniques (video-assisted thoracoscopic surgery [VATS] or robotic-assisted surgery) or open thoracotomy. Procedures include lobectomy, bilobectomy, pneumonectomy, or sleeve resection, combined with ipsilateral systematic mediastinal lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| SFRT + Tislelizumab + Chemotherapy | Experimental | Participants receive spatially fractionated radiotherapy (lattice radiation therapy) to the primary lung tumor, with a prescription dose of GTV 20 Gy in 5 fractions and GTV-Lattice 60 Gy in 5 fractions, delivered on Monday, Wednesday, and Friday over one week. Following SFRT, participants receive 2 to 4 cycles (depending on clinical evaluation and per protocol specifications) of tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle (Q3W), combined with platinum-based doublet chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m², plus pemetrexed 500 mg/m² for non-squamous histology or paclitaxel 175 mg/m² for squamous histology). Definitive radical surgery (lobectomy, bilobectomy, pneumonectomy, or sleeve resection with systematic mediastinal lymph node dissection) is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. The first 6 enrolled patients undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drugs. Receives: Radiation: Spatially Fractionated Radiotherapy (SFRT); Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Procedure: Radical Lung Resection Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
MPR is defined as the proportion of participants with ≤10% viable tumor cells remaining in the resected primary tumor specimen. Assessment method: based on the longest diameter (a cm) of the gross tumor, at least one pathological section per cm is stained with H\&E; the percentages of viable tumor cells, necrosis, stroma, and inflammatory cells are calculated for each section, and the average percentage of viable tumor cells is derived. MPR is achieved when this average is ≤10%.
Measured: Assessed at the time of surgical resection, performed 4-6 weeks (±7 days) after the last dose of neoadjuvant therapy.
Secondary outcomes (8)
1-Year Event-Free Survival (EFS) Rate
EFS is defined as the time from enrollment to the first occurrence of any of the following events: (a) disease progression per RECIST v1.1 before surgery precluding resection; (b) local disease progression preventing surgery; (c) postoperative local, regional, or distant recurrence; or (d) death from any cause. The 1-year EFS rate will be estimated using the Kaplan-Meier method.
Measured: At 1 year after enrollment
Pathological Complete Response (pCR) Rate
pCR is defined as the absence of residual invasive viable tumor cells in both the resected primary tumor and all sampled regional lymph nodes (i.e., ypT0/Tis ypN0) upon pathological evaluation.
Measured: At the time of surgical resection
Objective Response Rate (ORR)
ORR is defined as the proportion of participants whose best overall response is either Complete Response (CR) or Partial Response (PR) per RECIST v1.1.
Measured: At the pre-operative imaging assessment (within 14 days before surgery)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants whose best overall response is CR, PR, or Stable Disease (SD) per RECIST v1.1.
Measured: At the pre-operative imaging assessment (within 14 days before surgery)
R0 Resection Rate
R0 resection rate is defined as the proportion of participants who undergo radical surgery and have microscopically negative margins (R0) on final pathology.
Measured: At the time of surgery
1-Year Overall Survival (OS) Rate
OS is defined as the time from enrollment to death from any cause. The 1-year OS rate will be estimated using the Kaplan-Meier method.
Measured: At 1 year after enrollment
Time to Distant Metastasis (TTDM)
TTDM is defined as the time from enrollment to the first documented distant metastasis.
Measured: During post-operative follow-up (assessed at 1 month after surgery, then every 3 months for the first 2 years, and every 6 months for years 3-5, with chest/abdominal CT and, if indicated, brain MRI/CT)
Safety and Tolerability
Safety endpoints include: (a) incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), and immune-related AEs (irAEs); (b) proportion of participants discontinuing treatment due to AEs; (c) changes from baseline in vital signs, physical examination findings, and laboratory parameters (hematology, serum chemistry, urinalysis, ECG, etc.). AEs will be graded according to NCI CTCAE v5.0.
Measured: From signing of informed consent through 90 days after the last dose (SAEs reported up to 90 days; SAEs considered related to study drugs reported beyond 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Bin, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775040
- Sponsor's protocol ID
- KY-2026-189-02
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Tislelizumab and Platinum-based Doublet Chemotherapy as Induction/Conversion Therapy for Potentially Resectable Stage III Non-small Cell Lung Cancer With Bulky Disease.
- ClinicalTrials.gov ID
- NCT07775040
- Acronym / sponsor ID
- KY-2026-189-02
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer (Stage III, Bulky Disease, Potentially Resectable)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Aug 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.
This is a prospective, single-arm, multicenter phase II clinical study evaluating the efficacy and safety of spatially fractionated radiotherapy (SFRT) combined with tislelizumab and platinum-based doublet chemotherapy as induction/conversion therapy for patients with potentially resectable stage III non-small cell lung cancer (NSCLC) with bulky disease (primary tumor >5 cm).
SFRT, also known as lattice radiation therapy, is a novel radiotherapy technique that creates alternating high-dose and low-dose regions within the tumor. This approach not only reduces tumor burden but also may enhance anti-tumor immune responses, potentially working synergistically with immunotherapy.
Study participants will receive SFRT to the primary lung tumor (GTV 20 Gy/5 fractions, GTV-Lattice 60 Gy/5 fractions), followed by 2-4 cycles of tislelizumab (200 mg, Q3W) combined with platinum-based doublet chemotherapy. Surgery will be performed 4-6 weeks after the last cycle of neoadjuvant therapy. The first 6 enrolled patients will undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drug.
The primary endpoint is major pathological response (MPR) rate, defined as the proportion of patients with ≤10% viable tumor cells in the resected specimen. Secondary endpoints include 1-year event-free survival (EFS), pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), R0 resection rate, 1-year overall survival (OS), time to distant metastasis (TTDM), and safety.
A total of 44 patients will be enrolled across multiple centers in China. An interim analysis will be conducted after 50% of patients are enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SFRT + Tislelizumab + Chemotherapy | Experimental | Radiation: Spatially Fractionated Radiotherapy (SFRT), Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Procedure: Radical Lung Resection SurgeryParticipants receive spatially fractionated radiotherapy (lattice radiation therapy) to the primary lung tumor, with a prescription dose of GTV 20 Gy in 5 fractions and GTV-Lattice 60 Gy in 5 fractions, delivered on Monday, Wednesday, and Friday over one week. Following SFRT, participants receive 2 to 4 cycles (depending on clinical evaluation and per protocol specifications) of tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle (Q3W), combined with platinum-based doublet chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m², plus pemetrexed 500 mg/m² for non-squamous histology or paclitaxel 175 mg/m² for squamous histology). Definitive radical surgery (lobectomy, bilobectomy, pneumonectomy, or sleeve resection with systematic mediastinal lymph node dissection) is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. The first 6 enrolled patients undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drugs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary agreement to participate and signed written informed consent.
- Cytologically or histologically confirmed (via percutaneous lung biopsy, bronchoscopy, mediastinoscopy, etc.) bulky stage III non-small cell lung cancer (NSCLC) per AJCC 9th edition staging, with primary tumor >5 cm (T3-T4), N0-N2, and no prior chemotherapy, radiotherapy, surgery, or immunotherapy.
- Pulmonary lesion considered potentially resectable by a multidisciplinary team (MDT) including a thoracic surgeon.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Adequate hematologic and organ function as demonstrated by:
Key exclusion criteria (15 listed)
- Has or is suspected of having an autoimmune disease. Note: patients with vitiligo, type I diabetes mellitus, or hypothyroidism (Hashimoto's thyroiditis) requiring only hormone replacement therapy may be enrolled if no significant signs of recurrence are present.
- Requires systemic corticosteroid therapy (>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10 mg prednisone or equivalent per day) for patients without active autoimmune disease, are permitted.
- Prior history of thoracic radiotherapy.
- Active bleeding prior to treatment.
- Severe cardiac, pulmonary, hepatic, renal, or hematopoietic dysfunction, cachexia, or any condition that would preclude tolerance to radiochemotherapy.
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 |
|---|---|---|
| Spatially Fractionated Radiotherapy (SFRT)Participants receive lattice radiation therapy to the primary lung tumor. The gross tumor volume (GTV) is delineated, and lattice target volumes (GTV-Lattice) are generated using a hexagonal close-packed model within the tumor. Volumetric modulated arc therapy (VMAT) plans are designed. Prescription dose: GTV receives 20 Gy in 5 fractions, and GTV-Lattice receives 60 Gy in 5 fractions. After plan verification, treatment is delivered on 3 non-consecutive working days (e.g., Monday, Wednesday, Friday). | Radiation | SFRT + Tislelizumab + Chemotherapy |
| Tislelizumab200 mg administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles, starting on Day 8-15 following SFRT. | Drug | SFRT + Tislelizumab + Chemotherapy |
| CarboplatinAUC 5 administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion. | Drug | SFRT + Tislelizumab + Chemotherapy |
| Cisplatin75 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion. Adequate hydration and antiemetic prophylaxis are required. | Drug | SFRT + Tislelizumab + Chemotherapy |
| Pemetrexed500 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with non-squamous NSCLC. Vitamin B12 and folic acid supplementation are required per standard practice. | Drug | SFRT + Tislelizumab + Chemotherapy |
| Paclitaxel175 mg/m² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with squamous NSCLC. Premedication to prevent hypersensitivity is required per standard practice. | Drug | SFRT + Tislelizumab + Chemotherapy |
| Radical Lung Resection SurgeryDefinitive radical surgery is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. Surgical approaches include minimally invasive techniques (video-assisted thoracoscopic surgery [VATS] or robotic-assisted surgery) or open thoracotomy. Procedures include lobectomy, bilobectomy, pneumonectomy, or sleeve resection, combined with ipsilateral systematic mediastinal lymph node dissection. | Procedure or surgery | SFRT + Tislelizumab + Chemotherapy |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: Assessed at the time of surgical resection, performed 4-6 weeks (±7 days) after the last dose of neoadjuvant therapy.
MPR is defined as the proportion of participants with ≤10% viable tumor cells remaining in the resected primary tumor specimen. Assessment method: based on the longest diameter (a cm) of the gross tumor, at least one pathological section per cm is stained with H\&E; the percentages of viable tumor cells, necrosis, stroma, and inflammatory cells are calculated for each section, and the average percentage of viable tumor cells is derived. MPR is achieved when this average is ≤10%.
8 secondary outcomes
1-Year Event-Free Survival (EFS) Rate
Time frame: At 1 year after enrollment
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgical resection
Objective Response Rate (ORR)
Time frame: At the pre-operative imaging assessment (within 14 days before surgery)
Disease Control Rate (DCR)
Time frame: At the pre-operative imaging assessment (within 14 days before surgery)
R0 Resection Rate
Time frame: At the time of surgery
1-Year Overall Survival (OS) Rate
Time frame: At 1 year after enrollment
Time to Distant Metastasis (TTDM)
Time frame: During post-operative follow-up (assessed at 1 month after surgery, then every 3 months for the first 2 years, and every 6 months for years 3-5, with chest/abdominal CT and, if indicated, brain MRI/CT)
Safety and Tolerability
Time frame: From signing of informed consent through 90 days after the last dose (SAEs reported up to 90 days; SAEs considered related to study drugs reported beyond 90 days)
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 Aug 2026.
- 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.
peng xu, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spatially Fractionated Radiotherapy (SFRT), Tislelizumab and Carboplatin in people with Non-Small Cell Lung Cancer, run by Sichuan Cancer Hospital and Research Institute 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 14 inclusion and 15 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 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 bin hu, PhD (028-85420367, hubin@sczlyy.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: Assessed at the time of surgical resection, performed 4-6 weeks (±7 days) after the last dose of neoadjuvant therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.