NSCLC (Non-small Cell Lung Cancer)Phase 2CTONG 2508NCT07120698
Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
A Phase 2 study testing Sintilimab in people with NSCLC (Non-small Cell Lung Cancer) and MRD, run by Guangdong Association of Clinical Trials at 2 sites in China.
Trial summary
This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after… Read more about this study
- Who is it for?
- Ages 28 to 75 years
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer), MRD, II-IIIB Stages
- What is being tested?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesChina
- Study dates
- 5 Nov 2025to 26 Jul 2029
- 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 28 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to the initiation of any trial-related procedures.
- Male or female aged ≥18 years and ≤75 years.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.
- Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy. All gross tumors must be completely resected at the end of surgery, and all surgical margins of the resected tumors must be negative. Systemic lymph node dissection is required.
- Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to the AJCC 8th edition TNM classification for lung cancer. Resectable N2 refers to non-massive (defined as short-axis diameter <3 cm), discrete, or single-station N2 involvement. If clinically suspected of N2 or N3, pathological confirmation is recommended whenever feasible.
Show all 23Show fewer
- Patients with pathological response assessment of 1%-90% residual viable tumor (RVT).
- No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor.
- No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer.
- Completed radical surgery for lung cancer 4-12 weeks prior to study enrollment, with pathological confirmation of R0 resection and radiological evidence of no residual tumor foci 1 month after radical surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy >6 months.
- Adequate organ function:
- 1. Absolute neutrophil count (ANC) ≥1.5×10^9/L without the use of granulocyte colony-stimulating factor within the past 14 days.
- 2. Platelets ≥100×10^9/L without transfusion within the past 14 days. 3. Hemoglobin >9 g/dL without transfusion or use of erythropoiesis-stimulating agents within the past 14 days.
- 4. Total bilirubin ≤1.5× upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN).
- 6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min.
- 7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
- 8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range are eligible if total T3 (or free T3) and free T4 are within the normal range.
- 9. Cardiac enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed not clinically significant by the investigator are also eligible).
- 14. For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Postmenopausal women are defined as those who have been amenorrheic for at least 1 year, or those who have undergone surgical sterilization or hysterectomy.
- 15. All subjects (regardless of gender) at risk of conception must use contraception with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).
- 16. Provide samples for MRD assessment (surgical tissue + blood).
Who cannot join
- Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected).
- Received adjuvant radiotherapy prior to dosing.
- Patients who underwent pneumonectomy.
- Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
- Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy.
- Presence of unhealed surgical incisions, ulcers, or fractures.
Show all 12Show fewer
- In the investigator's opinion, severe concomitant systemic diseases that may affect the subject's ability to complete the study. Subjects with positive autoimmune antibodies must be assessed and confirmed by the investigator to have no autoimmune diseases requiring systemic treatment before enrollment.
- Presence of primary immunodeficiency diseases.
- Receiving systemic corticosteroid therapy within 7 days prior to the first dose of the study (excluding intranasal, inhaled, or other topical corticosteroids). Note: The use of physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted.
- Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to the active ingredient or excipients of the study drug, sintilimab.
- Not fully recovered from toxicities and/or complications caused by any prior interventions prior to the start of treatment (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The third people's hospital of chengdu
Chengdu, Sichuan, 610031
Yi Y Yang, 13980013944, cd3yyyy@126.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Ben yuan Jiang, 15918748727, jiangbenyuan@gdph.org.cn
About this study
Official title: Adaptive Adjuvant Sintilimab Therapy Guided by MRD in II-IIIB Stage NSCLC Patients With Non-pCR Pathological Response After Neoadjuvant Immunotherapy Combined With Chemotherapy: a Prospective, Multi-center, Single-arm, Phase II Trial
This is a multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.
Read the detailed description
Patients with Stage II-IIIB NSCLC who have not achieved a pathological complete response after neoadjuvant immunotherapy combined with chemotherapy will be enrolled in this study. Eligible patients will receive adjuvant sintilimab therapy guided by MRD.
Patients should undergo a test 3 to 7 days after surgery, and another test 28 days (±3 days) after. surgery The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD test results or a single positive MRD test result will be included in the MRD + treatment cycle: they will receive adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns negative, treatment will be discontinued and participants will be monitored. If the MRD test result remains positive, sintilimab treatment will continue.
Participants with two consecutive negative MRD test results will be included in the MRD - treatment cycle: they will only receive follow-up observation. Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns positive, adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks) will be initiated. If the MRD test result remains negative, follow-up observation will continue.
The maximum number of treatment cycles for sintilimab therapy is 18 cycles. Safety will be evaluated through adverse events (AE) and laboratory tests.
- Being tested
- Sintilimab
- Keywords
- MRD, II-IIIB stages, NSCLC (non-small cell lung cancer), adjuvant immunotherapy
- 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.
SintilimabDrug
Patients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD.
Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle：they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue.
Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle：they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | sintilimab Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year EFS rate
Event-free survival (EFS) is defined as the time from the date of randomization (or the start of treatment) to the first occurrence of any of the following events: disease progression, local or distant recurrence, or death due to any cause. If a patient does not experience any of these events within 2 years, they are considered to have achieved 2-year EFS.
Measured: 2 year after treatment initiation
Secondary outcomes (5)
mEFS
The median Event-Free Survival (mEFS) is defined as the median time from the date of randomization or the initiation of treatment to the first occurrence of a prespecified event, such as disease progression, death, or change in treatment regimen.
Measured: From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
2-year OS rate
The 2-year Overall Survival (OS) rate is defined as the proportion of patients who remain alive at the specific time point of 2 years from the date of randomization or the initiation of treatment.
Measured: 24 months
mOS
The median overall survival (mOS) is defined as from date of enrollment until the date of first documented date of death from any cause, whichever came first, assessed up to 40 months, at which the survival rate is 50%.
Measured: OS is defined as the time from enrollment to death, regardless of disease recurrence, assessed up to 100 months
AEs
Safety and tolerability will be assessed by the incidence of adverse events (AEs), serious adverse events (SAEs), immune-related adverse events (irAEs), deaths, and laboratory abnormalities.
Measured: 24 months
QoL
Per physician's discretion, the patient will complete one or more of the following QoL instruments:
EQ-5D is a 5 item questionnaire with a total score ranging from 0 to 100 with the higher score indicating greater satisfaction, EORTC QLQ-C30 is a 30 item questionnaire with a total score ranging from 1 to 4 with the lower score indicating greater satisfaction.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start5 Nov 2025
- Primary completion26 Jun 2029 (estimated)
- Study completion26 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies 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
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Zunyi Medical College, Suining Central Hospital, Shenzhen Second People's Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Yi Yang, Guangdong Association of Clinical Trials
- Investigators
- Yang, Principal investigator, Guangdong Association of Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120698
- Sponsor's protocol ID
- 2025-S-174
- Acronym
- CTONG 2508
- Status last verified
- Dec 2025
- First submitted
- 8 Jul 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share individual participant data (IPD) because the original informed-consent forms signed by participants did not explicitly cover secondary use of their data by external parties, and thus sharing IPD would risk violating the approved ethics agreement.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Adjuvant Sintilimab Therapy Guided by MRD in II-IIIB Stage NSCLC Patients With Non-pCR Pathological Response After Neoadjuvant Immunotherapy Combined With Chemotherapy: a Prospective, Multi-center, Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT07120698
- Acronym / sponsor ID
- CTONG 2508 / 2025-S-174
- Keywords
- MRD, II-IIIB stages, NSCLC (non-small cell lung cancer), adjuvant immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Collaborators
- Zunyi Medical College, Suining Central Hospital, Shenzhen Second People's Hospital, Guangdong Provincial People's Hospital
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 26 Jun 2029 (estimated)
- Study completion
- 26 Jul 2029 (estimated)
- First posted
- 13 Aug 2025 (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 multicenter, prospective, open-label Phase II study designed to evaluate the safety and efficacy of adjuvant sintilimab therapy guided by minimal residual disease (MRD) in patients with Stage II-IIIB non-small cell lung cancer (NSCLC) who have not achieved a pathological complete response (non-pCR) after neoadjuvant immunotherapy combined with chemotherapy. The study is being conducted at the Third People's Hospital of Chengdu and the Guangdong Provincial People's Hospital.
Detailed description
Patients with Stage II-IIIB NSCLC who have not achieved a pathological complete response after neoadjuvant immunotherapy combined with chemotherapy will be enrolled in this study. Eligible patients will receive adjuvant sintilimab therapy guided by MRD.
Patients should undergo a test 3 to 7 days after surgery, and another test 28 days (±3 days) after. surgery The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD test results or a single positive MRD test result will be included in the MRD + treatment cycle: they will receive adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns negative, treatment will be discontinued and participants will be monitored. If the MRD test result remains positive, sintilimab treatment will continue.
Participants with two consecutive negative MRD test results will be included in the MRD - treatment cycle: they will only receive follow-up observation. Follow-up will be conducted every 3 months, during which chest CT scans and MRD tests will be performed. If the MRD test result turns positive, adjuvant therapy with sintilimab (200 mg, intravenous infusion, every 3 weeks) will be initiated. If the MRD test result remains negative, follow-up observation will continue.
The maximum number of treatment cycles for sintilimab therapy is 18 cycles. Safety will be evaluated through adverse events (AE) and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Sintilimabsintilimab |
Who may qualify
- Ages
- 28 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed written informed consent prior to the initiation of any trial-related procedures.
- Male or female aged ≥18 years and ≤75 years.
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy.
- Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy. All gross tumors must be completely resected at the end of surgery, and all surgical margins of the resected tumors must be negative. Systemic lymph node dissection is required.
Key exclusion criteria (12 listed)
- Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely resected).
- Received adjuvant radiotherapy prior to dosing.
- Patients who underwent pneumonectomy.
- Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
- Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy.
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 |
|---|---|---|
| SintilimabPatients who met the inclusion criteria were treated with adaptive adjuvant sintilimab therapy guided by MRD. Patients should test twice at postoperative days 3 to 7 and again at postoperative day 28 (±3 days). The results of these two tests will be used to determine the subsequent treatment pathway. Participants with two consecutive positive MRD tests or a single positive MRD test will be enrolled in the MRD+ treatment cycle：they will receive adjuvant treatment with sintilimab (200 mg, intravenous infusion, every 3 weeks). Follow-up visits will be conducted every 3 months, during which chest CT scans and MRD testing will be performed. If MRD becomes negative, treatment will be discontinued and the participant will be monitored. If MRD remains positive, treatment with sintilimab will continue. Participants with two consecutive negative MRD tests will be enrolled in the MRD- treatment cycle：they will undergo follow-up observation only. Follow-up visits will be conducted every 3 months | Drug | Experimental arm |
Primary outcome
2-year EFS rate
Time frame: 2 year after treatment initiation
Event-free survival (EFS) is defined as the time from the date of randomization (or the start of treatment) to the first occurrence of any of the following events: disease progression, local or distant recurrence, or death due to any cause. If a patient does not experience any of these events within 2 years, they are considered to have achieved 2-year EFS.
5 secondary outcomes
mEFS
Time frame: From enrollment to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
2-year OS rate
Time frame: 24 months
mOS
Time frame: OS is defined as the time from enrollment to death, regardless of disease recurrence, assessed up to 100 months
AEs
Time frame: 24 months
QoL
Time frame: 24 months
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 5 Jan 2026.
- Individual participant dataSharing planned: No. We will not share individual participant data (IPD) because the original informed-consent forms signed by participants did not explicitly cover secondary use of their data by external parties, and thus sharing IPD would risk violating the approved ethics agreement.
Related trials for NSCLC (Non-small Cell Lung Cancer)
RecruitingPhase 1/2
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer (NSCLC)
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma
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.
Yang principal investigator
Guangdong Association of Clinical Trials
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sintilimab in people with NSCLC (Non-small Cell Lung Cancer) and MRD, run by Guangdong Association of Clinical Trials at 2 sites 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 23 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yi Yang (+8613980013944, cd3yyyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year EFS rate (time frame: 2 year after treatment initiation). 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 5 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.