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Recruiting Phase 2 NCT06667154

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

Trial Parameters

Condition Lung Cancer, Nonsmall Cell
Sponsor Aline Fusco Fares, MD
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 33
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-10
Completion 2025-10-31
Interventions
Low-dose nivolumab combined with platinum-based doublet chemotherapy

Brief Summary

The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.

Eligibility Criteria

Inclusion Criteria: * Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol. * Male or female, aged 18 years or older. * Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA. * Receiving treatment at Hospital de Base. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose. * Tumor sample meets the following requirements: * Negative for EGFR gene expression. * Negative for ALK and ROS1 protein expression. * PD-L1 protein expression documented and assessable. * Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review. * Adequate organ and bone marrow function as defined below: * Hemoglobin: ≥ 9.0 g/dL\* * Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\* * Pl

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