OncoMatch/Clinical Trials/NCT07120698
Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung)
Is NCT07120698 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab for nsclc (non-small cell lung cancer).
Treatment: Sintilimab — 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.
Check if I qualifyExtracted eligibility criteria
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)
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.
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