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

NCT03177291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-05

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jhanelle Gray, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-26
Primary Completion
2021-05-09
Completion
2024-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03177291 on ClinicalTrials.gov