Pirfenidone + Chemotherapy for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: CYP1A2 inhibitors

Disqualifiers: Brain metastases, Drug dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jhanelle Gray, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

This trial is for adults with advanced-stage non-small cell lung cancer (NSCLC) who haven't had chemotherapy for their stage IV disease. They must have good organ function, no severe allergies to the drugs being tested, and not be on certain other medications. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

I have previously received immunotherapy.

You have at least one tumor that can be measured according to specific guidelines.

Your blood and urine tests must show normal levels for liver and kidney function, and women must have a negative pregnancy test before starting the study.

Exclusion Criteria

My thyroid condition is not under control.

I am allergic to pirfenidone, carboplatin, pemetrexed, or paclitaxel.

I am not receiving any other cancer treatments and do not have another active cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Dose Escalation

A single center, dose-escalation study of pirfenidone combined with standard chemotherapy to determine the recommended Phase II dose

6 months

Multiple visits as per 3+3 design

Phase Ib Dose Expansion

Evaluate early signs of efficacy and obtain more toxicity data with pirfenidone and standard chemotherapy

6 months

Regular visits for efficacy and toxicity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 48 months

Treatment Details

Interventions

• Carboplatin
• Paclitaxel
• Pemetrexed
• Pirfenidone

Trial Overview The study tests Pirfenidone combined with standard first-line chemotherapy drugs (Carboplatin, Pemetrexed, Paclitaxel) in patients with NSCLC. Pirfenidone is usually used for a lung condition called IPF but isn't yet approved for NSCLC.

Participant Groups

Group I: Non-Squamous Cell Lung Cancer (SQCLC) Active Control 3 Interventions

Arm B Combination Therapy: Pirfenidone combined with standard first-line chemotherapy. Participants will receive the combination of Pirfenidone and carboplatin plus pemetrexed in study treatment cycles that last 21 days. Phase 1 Dose Escalation; followed by Phase 1b Dose Expansion.

Group II: Squamous Cell Lung Cancer (SQCLC) Active Control 3 Interventions

Arm A Combination Therapy: Pirfenidone combined with standard first-line chemotherapy. Participants will receive the combination of Pirfenidone and carboplatin plus paclitaxel in study treatment cycles that last 21 days. Phase 1 Dose Escalation; followed by Phase 1b Dose Expansion.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+