Adebrelimab and Famitinib After Surgery for Non-Small Cell Lung Cancer With Remaining Tumor

Trial details

Who runs it

Ruijin Hospital

Trial code

NCT07890636

Record updated

22 October 2026

Original description

Neoadjuvant immunotherapy combined with chemotherapy followed by surgery has become an important treatment strategy for resectable non-small cell lung cancer (NSCLC). However, patients who do not achieve a pathological complete response (non-pCR) after neoadjuvant treatment remain at a high risk of disease recurrence, and optimal postoperative adjuvant treatment for these patients remains unclear. Adebrelimab, an immune checkpoint inhibitor targeting PD-L1, and famitinib, a multitarget tyrosine kinase inhibitor with antiangiogenic activity, may have complementary antitumor effects. Therefore, we conduct this prospective, single-arm, phase II clinical trial to investigate the efficacy and safety of adebrelimab combined with famitinib as postoperative adjuvant therapy in patients with resectable NSCLC who did not achieve pCR after neoadjuvant chemoimmunotherapy followed by surgery.Read full original descriptionShow less

A Prospective, Single-Arm, Phase II Study of the Efficacy and Safety of Adebrelimab in Combination With Famitinib as Postoperative Adjuvant Therapy for NSCLC Patients Who Did Not Achieve Pathological Complete Response

Neoadjuvant immunotherapy combined with chemotherapy followed by surgery has become an important treatment strategy for resectable non-small cell lung cancer (NSCLC). However, patients who do not achieve a pathological complete response (non-pCR) after neoadjuvant treatment remain at a high risk of disease recurrence, and optimal postoperative adjuvant treatment for these patients remains unclear. Adebrelimab, an immune checkpoint inhibitor targeting PD-L1, and famitinib, a multitarget tyrosine kinase inhibitor with antiangiogenic activity, may have complementary antitumor effects. Therefore, we conduct this prospective, single-arm, phase II clinical trial to investigate the efficacy and safety of adebrelimab combined with famitinib as postoperative adjuvant therapy in patients with resectable NSCLC who did not achieve pCR after neoadjuvant chemoimmunotherapy followed by surgery.

Inclusion: Patients aged 18-75 years, male or female; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), initially diagnosed as stage II-IIIB according to the AJCC 9th edition. Stage IIIB disease is restricted to N2 involvement, with non-bulky lymph nodes (short-axis diameter <2 cm) considered completely resectable by the investigator or multidisciplinary team; Patients who have received 2-4 cycles of neoadjuvant adebrelimab combined with platinum-based doublet chemotherapy followed by radical surgery, with postoperative pathological confirmation of non-pathological complete response (non-pCR); No prior anticancer treatment other than the specified neoadjuvant chemoimmunotherapy, including radiotherapy or targeted therapy; Adequate pulmonary function for curative-intent R0 resection, as assessed by the treating thoracic surgeon; Adequate organ function, including absolute neutrophil count ≥1.8 × 10⁹/L, hemoglobin ≥100 g/L, platelet count ≥125 × 10⁹/L, total bilirubin ≤1.5 × upper limit of normal (ULN), ALT and AST ≤2.5 × ULN, serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min, without blood transfusion, hematopoietic growth factors, or corrective medication within 14 days; Women of childbearing potential must have a negative pregnancy test within 3 days before the first dose and agree to use effective contraception during treatment and for 180 days after the last dose. Male patients with partners of childbearing potential must also agree to use effective contraception during the same period; Patients voluntarily participate in the study, provide written informed consent, and agree to comply with the study procedures and follow-up.

Exclusion: Patients who have received systemic immunosuppressive medications within 4 weeks before the first dose of study treatment, except intranasal or inhaled corticosteroids or physiological doses of systemic corticosteroids (≤10 mg/day prednisone equivalent), discontinued for at least 1 week; Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned vaccination during the study; Current participation in another interventional clinical trial or receipt of investigational drugs or devices within 4 weeks before the first dose, or failure to recover from previous treatment-related toxicities to grade ≤1 or baseline, except fatigue or alopecia; Severe infection requiring intravenous antibiotics, antifungal, or antiviral treatment within 4 weeks before the first dose, or unexplained fever >38.5°C during screening; T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina; T4 tumors with separate tumor nodules in different ipsilateral lobes; or superior sulcus (Pancoast) tumors; History of malignancy other than NSCLC within the past 5 years; History of or suspected pneumonitis, interstitial lung disease, or other pulmonary conditions that may interfere with pulmonary function assessment; Active autoimmune disease or history of autoimmune disease. Patients with hypothyroidism controlled by hormone replacement therapy, vitiligo, or resolved childhood asthma requiring no treatment in adulthood may be eligible. Patients requiring bronchodilator treatment are excluded; Known congenital or acquired immunodeficiency, including HIV infection, active hepatitis B, hepatitis C, HBV/HCV coinfection, or alcoholic cirrhosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known allergy, hypersensitivity, or intolerance to the study drugs or their components; Patients with known psychiatric disorders or substance abuse that may interfere with study participation; Any underlying medical condition that, in the investigator's opinion, may compromise patient safety or prevent compliance with study requirements; Patients with known EGFR mutations or ALK alterations; Significant cardiovascular disease, including myocardial ischemia or infarction, uncontrolled arrhythmia (QTc ≥450 ms in males or ≥470 ms in females), heart failure of NYHA class II or higher, left ventricular ejection fraction <50%, myocardial infarction within 6 months, uncontrolled angina, clinically significant pericardial disease, or active ischemic or conduction abnormalities; Creatine kinase (CK) >3 × ULN, history of severe bleeding events, or arterial or venous thromboembolic events.

ClinicalTrials.gov NCT07890636