Phase II clinical trial of Neo-adjuvant chemo/immunotherapy followed by adjuvant treatment depending on the resection status for the treatment of NSCLC patients diagnosed with pancoast tumor. A multicenter exploratory study_DUMAS

Resectable Non-small cell lung cancer Pancoast tumor

The primary objective is to estimate progression-free survival (PFS) at 24 months from diagnosis. The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first.

1. Overall survival rate (OS) at 24 months: Overall survival is defined as the time between the date of enrollment and the date of death. OS will be censored on the last date a participant was known to be alive, 2. Complete resection (R0) after induction treatment with chemotherapy plus nivolumab, 3. Objective treatment response rate (ORR), Disease control rate (DCR) and Duration of response (DOR). Systemic ORR, defined as a complete or partial response as determined by the investigator according to RECIST v1.1., 4. Pathological response and percentage of Residual tumor viable (RTV%) in the primary tumor: pathological complete response (pCR) defined as the absence of residual tumor, Major pathological response rate (MPR), defined as number of randomized participants with <10% residual tumor, 5. Safety and tolerability: will be measured by incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Association between treatment adverse events and PFS and OS will be determined. Adverse events will be graded according to CTCAE v5.0., 6. Biomarker endpoints: study of the prognostic value of the basal ctDNA (association of basal levels with PFS and OS)

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