Spots Global Cancer Trial Database for Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

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Trial Identification

Brief Title: Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

Official Title: A Phase I/Ib Trial of Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

Study ID: NCT03177291

Conditions

Lung Cancer

Non Small Cell Lung Cancer

Advanced Cancer

Metastatic Lung Cancer

Squamous Cell Lung Cancer

Non-Squamous Non-Small Cell Neoplasm of Lung

Interventions

Study Description

Brief Summary: The purpose of this study is to find out what effects (good and/or bad) Pirfenidone combined with standard first-line chemotherapy will have on you and non-small cell lung cancer (NSCLC). The investigational drug Pirfenidone is being combined with standard chemotherapy in participants with advanced non-small cell lung cancer. Pirfenidone is approved to treat idiopathic pulmonary fibrosis (IPF) but it isn't currently approved to treat non-small cell lung cancer.

Detailed Description: This study will be conducted in two phases: 1) a Phase I dose escalation study with a Standard 3+3 design to determine the recommended Phase II dose and 2) a Phase Ib expansion study to evaluate early signs of efficacy and obtain more toxicity data. The Phase I trial will be a single center, dose-escalation study of pirfenidone combined with standard chemotherapy in the treatment of advanced/metastatic NSCLC, followed by a Phase Ib trial to determine early clinical efficacy \[objective tumor response rate (ORR)\] and toxicity data.