The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.
Target population is unresectable stage III non-small cell lung cancer.
Written informed consent provided.
Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene.
Male and female patients aged ≥18 years, < 75 years.
Known severe hypersensitivity to IBI308 or any of the excipients of this product.
Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Prior chemotherapy or radiotherapy.
Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
Single group
IBI308
DrugIBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.
Bevacizumab
DrugBevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.
Pemetrexed
DrugPemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.
Carboplatin
DrugCarboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.
Thoracic surgery
Procedure/SurgerySurgery will be performed at least 21 days after the last dose of neoadjuvant therapy.
Resectability rate
Resectability rate was defined as the percentage of patients who were able to undergo surgery after induction.
Number of participants with perioperative complications
Safety
Event-free survival
Event-free survival was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first.
Overall survival
Overall survival was assessed from randomization to death as a result of any cause.
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