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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

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

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung) (NCT07120698) is a Phase 2 interventional studying NSCLC (Non-small Cell Lung Cancer) and MRD, sponsored by Guangdong Association of Clinical Trials. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NSCLC (Non-small Cell Lung Cancer) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 115 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused NSCLC (Non-small Cell Lung Cancer) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed written willing to sign a consent form prior to the initiation of any trial-related procedures. 2. Male or female aged ≥18 years and ≤75 years. 3. diagnosed by tissue sample (biopsy-confirmed) non-small cell lung cancer (NSCLC). 4. Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy. 5. 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. 6. 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. 7. Patients with pathological response assessment of 1%-90% residual viable tumor (RVT). 8. No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor. 9. No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer. 10. 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. 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 12. Life expectancy \>6 months. 13. your organs (liver, kidneys, etc.) are working well enough based on blood tests: 1\. Absolute neutrophil count (ANC) ≥1.5×10\^9/L without the use of granulocyte colony-stimulating factor within the past 14 days. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed written informed consent prior to the initiation of any trial-related procedures. 2. Male or female aged ≥18 years and ≤75 years. 3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 4. Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy. 5. 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. 6. 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. 7. Patients with pathological response assessment of 1%-90% residual viable tumor (RVT). 8. No EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions. Other potentially targetable driver gene alterations will be determined in consultation with the sponsor. 9. No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer. 10. 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. 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 12. Life expectancy \>6 months. 13. 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). Exclusion Criteria: 1. 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). 2. Received adjuvant radiotherapy prior to dosing. 3. Patients who underwent pneumonectomy. 4. Currently participating in an interventional clinical study or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose. 5. Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy. 6. Presence of unhealed surgical incisions, ulcers, or fractures. 7. 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. 8. Presence of primary immunodeficiency diseases. 9. 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. 10. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 11. Known allergy to the active ingredient or excipients of the study drug, sintilimab. 12. 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).

Treatments Being Tested

DRUG

Sintilimab

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

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The third people's hospital of chengdu
Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07120698), the sponsor (Guangdong Association of Clinical Trials), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07120698 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07120698?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07120698?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07120698. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07120698. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.