NCT03177291View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 26, 2017

Primary Completion Date

May 9, 2021

Study Completion Date

December 4, 2024

Conditions
Lung CancerNon Small Cell Lung CancerAdvanced CancerMetastatic Lung CancerSquamous Cell Lung CancerNon-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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC | Biotech Hunter | Biotech Hunter