NCT03177291

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Pirfenidone	Pirfenidone: 267 mg Capsules by mouth (PO) 3 times per day (TID). Dose Escalation: Level 1:One capsule (total daily dose 801 mg); Level 2: Two capsules (total daily dose 1602 mg); Level 3: Three capsules (total daily dose 2403 mg). Dose Expansion: Treatment at dose determined by the Phase 1 Dose Escalation.
DRUG	Carboplatin	Area under the curve (AUC) 6 on Day 1 of a 21-day cycle for 4 - 6 cycles.
DRUG	Paclitaxel	200 mg/m\^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.
DRUG	Pemetrexed	500 mg/m\^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.

Timeline

• Start date: 2017-09-26
• Primary completion: 2021-05-09
• Completion: 2024-12-04
• First posted: 2017-06-06
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study