A Phase 2 interventional study of Adebrelimab and Adjuvant treatment in Lung Neoplasm Malignant, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
Lung cancer is one of the leading causes of cancer-related deaths worldwide. Neoadjuvant immunotherapy combined with platinum-based chemotherapy followed by surgery has significantly improved treatment outcomes in patients with resectable non-small cell lung cancer (NSCLC). However, patients with residual viable tumor after neoadjuvant treatment (non-pCR) remain at increased risk of postoperative recurrence. Adebrelimab is a monoclonal antibody targeting PD-L1 that enhances antitumor immune responses, while famitinib is a multitarget tyrosine kinase inhibitor with antiangiogenic activity. The combination of immune checkpoint blockade and antiangiogenic therapy may provide additional antitumor benefits. Therefore, we conduct this prospective, open-label, single-arm, multicenter phase II clinical trial to evaluate 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. A total of 64 patients with stage II-IIIB NSCLC (stage IIIB restricted to N2 disease) who have received 2-4 cycles of neoadjuvant adebrelimab plus platinum-based chemotherapy followed by radical surgery will be enrolled. Patients will receive adebrelimab (1200 mg intravenously every 3 weeks) combined with famitinib (20 mg orally once daily). The primary endpoint is the 2-year disease-free survival (DFS) rate. Secondary endpoints include DFS, overall survival (OS), and treatment-related adverse events.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 64 is close to the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Participants who have received 2-4 cycles of neoadjuvant adebrelimab combined with platinum-based chemotherapy followed by radical surgery without achieving a pathological complete response (non-pCR) will receive postoperative adjuvant treatment with adebrelimab (1200 mg, IV) every 3 weeks (Q3W) and famitinib (20 mg, orally) once daily. Treatment will continue for up to 16 cycles or until disease recurrence, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.
Drug: Adebrelimab · Drug: Adjuvant treatment
Adebrelimab 1200 mg, administered intravenously every 3 weeks (Q3W) for up to 16 cycles as postoperative adjuvant treatment.
Famitinib 20 mg, administered orally once daily in 21-day cycles as postoperative adjuvant treatment. Dose reduction to 15 mg is permitted in patients experiencing treatment-related toxicity.
2-Year Disease-Free Survival (DFS) Rate
The 2-year DFS rate is defined as the probability of patients remaining alive without disease recurrence or metastasis at 2 years from the first dose of postoperative adjuvant treatment with adebrelimab and famitinib.
Time frame: Up to 2 years from the first dose of study treatment.
Disease-Free Survival (DFS)
DFS is defined as the time from the first dose of postoperative adjuvant treatment to the first documented disease recurrence, metastasis, or death from any cause, whichever occurs first.
Time frame: From the first dose of study treatment, assessed up to 3 years.
Overall Survival (OS)
OS is defined as the time from the first dose of postoperative adjuvant treatment to death from any cause. Patients who are alive at the last follow-up will be censored at the date they were last known to be alive.
Time frame: From the first dose of study treatment, assessed up to 3 years.
Safety
The incidence and severity of treatment-related adverse events (TRAEs), serious adverse events (SAEs), and clinically significant laboratory abnormalities will be assessed. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Time frame: From informed consent to 30 days after the last dose for AEs, and up to 90 days after the last dose for SAEs/AESIs.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Adebrelimab