A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.
Trial Parameters
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Brief Summary
The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.
Eligibility Criteria
Inclusion Criteria: * Subjects voluntarily participated, signed an informed consent form (ICF), and were able to follow the study procedures. * Histopathologically confirmed squamous or non-squamous non-small cell lung cancer * Stage II-IIIB according to the 8th edition of the American Joint Committee on Cancer (AJCC) , and had received radical surgical resection (R0) treatment. * Participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery. * Non-squamous NSCLC subjects without EGFR-sensitizing mutation or ALK fusion gene. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug. Exclusion Criteria: * Currently participating in and receiving study treatment or participating in an investigational drug study and receiving st