Neoadjuvant Toripalimab Combined With Chemotherapy in Rare Mutations Stage IIB-IIIB NSCLC

What this Trial Is About

Researchers are evaluating the clinical feasibility and safety of combining Toripalimab with chemotherapy as a neoadjuvant treatment in patients with stage IIB-IIIB non-small cell lung cancer (NSCLC) that have rare genetic mutations. This Phase II, single-arm, open-label study focuses on patients with specific rare mutations including RET fusions, BRAF mutations, ERBB2 exon20 insertion, and MET alterations. The goal is to assess the pathological complete response after treatment and surgery. Participants will receive three cycles of Toripalimab (240 mg every 3 weeks) combined with either nab-paclitaxel plus carboplatin or pemetrexed plus carboplatin, chosen by investigators. After neoadjuvant treatment, patients may have surgery or radiation depending on their response. Following local treatment, optional adjuvant therapy including chemotherapy or targeted therapy with rare mutation TKIs may be given based on investigator decisions. During the study, researchers will collect blood samples before, during, and after treatment for analysis. Patients will be monitored for pathological response within two weeks after surgery, event-free survival up to 36 months, overall survival up to 60 months, and treatment-related adverse events up to 14 weeks. The total participation includes treatment, surgery or radiation, optional adjuvant therapy, and follow-up evaluations to assess outcomes and safety.

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC