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OncoMatch/Clinical Trials/NCT07120698

Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)

Is NCT07120698 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Sintilimab for nsclc (non-small cell lung cancer).

Phase 2RecruitingGuangdong Association of Clinical TrialsNCT07120698Data as of Jun 2026Location: China

Treatment: SintilimabThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Sintilimab

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Required: RET wild-type

Required: ROS1 wild-type

Disease stage

Required: Stage II, IIIA, IIIB (LIMITED TO RESECTABLE N2) (AJCC 8th edition TNM classification)

Clinical stage II, IIIA, or IIIB (limited to resectable N2) according to the AJCC 8th edition TNM classification for lung cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages 28–75

Prior therapy

Must have received: PD-1 inhibitor — neoadjuvant

Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy

Must have received: chemotherapy — neoadjuvant

Received 3-4 cycles of neoadjuvant immunotherapy (PD-1 inhibitor) combined with chemotherapy

Must have received: surgery — definitive

Underwent radical surgical treatment (R0), with surgical procedures including lobectomy or sleeve lobectomy

Cannot have received: anti-tumor treatment other than PD-1 inhibitors and chemotherapy

No prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy before radical surgery for lung cancer

Cannot have received: adjuvant radiotherapy

Received adjuvant radiotherapy prior to dosing

Cannot have received: neoadjuvant anti-tumor therapies other than chemotherapy and immunotherapy

Received neoadjuvant treatment with anti-tumor therapies other than chemotherapy and immunotherapy

Lab requirements

Blood counts

ANC ≥1.5×10^9/L without G-CSF within 14 days; platelets ≥100×10^9/L without transfusion within 14 days; hemoglobin >9 g/dL without transfusion or ESA within 14 days

Kidney function

Serum creatinine ≤1.5×ULN and creatinine clearance ≥60 ml/min

Liver function

Total bilirubin ≤1.5× ULN; AST and ALT ≤2.5×ULN (≤5×ULN with liver metastases)

Cardiac function

Cardiac enzyme profile within normal range (isolated lab abnormalities not clinically significant by investigator are eligible)

Adequate organ function: ... see full criteria for details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07120698 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-tumor treatment other than PD-1 inhibitors and chemotherapy, adjuvant radiotherapy, neoadjuvant anti-tumor therapies other than chemotherapy and immunotherapy disqualifies patients from enrollment.

Does this trial require ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

Does this trial require RET?

Yes, RET wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or IIIA or IIIB (LIMITED TO RESECTABLE N2) is required.

Is there an age limit?

Yes. Patients must be 75 years or younger and at least 28 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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