Platinum-Based Chemotherapy and Durvalumab for the Treatment of Stage IIIB or IV Non-small Cell Lung Cancer

Summary

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PRIMARY OBJECTIVE: I. To determine the 6-months progression-free survival (PFS) rate with the combination of dose attenuated doublet chemotherapy with durvalumab in advanced non-small cell lung cancer (NSCLC) patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 status or...

PRIMARY OBJECTIVE: I. To determine the 6-months progression-free survival (PFS) rate with the combination of dose attenuated doublet chemotherapy with durvalumab in advanced non-small cell lung cancer (NSCLC) patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 status or age >= 70. SECONDARY OBJECTIVES: I. To investigate overall response rate. II. To determine the safety profile of the regimen. III. To determine the median PFS and overall survival. EXPLORATORY OBJECTIVE: I. Exploratory investigation of biomarkers that could potentially serve as predictive indicators: characterize immunoprofile in peripheral blood by flow cytometry. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (SQUAMOUS NSCLC): Patients receive carboplatin intravenously (IV) over 15-60 minutes, paclitaxel IV over 3 hours and durvalumab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who do not progress receive durvalumab IV every 4 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. ARM II (NON-SQUAMOUS NSCLC): Patients receive carboplatin IV over 15-60 minutes, pemetrexed IV over 10 minutes and durvalumab IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who do not progress receive durvalumab IV and pemetrexed IV every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months.

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