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Alkylating agent

Pirfenidone + Chemotherapy for Lung Cancer

Phase 1

Waitlist Available

Led By Jhanelle Gray, M.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and older.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Must not have

Uncontrolled hyper- or hypothyroidism.

Known hypersensitivity to pirfenidone, carboplatin, pemetrexed or paclitaxel.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post final enrollment in phase 1 - up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding Pirfenidone to standard first-line chemotherapy will help people with NSCLC, and what side effects (good and/or bad) this combination may have.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include liver issues, nausea, fatigue, skin reactions from Pirfenidone; blood count changes from Carboplatin; kidney toxicity and nerve damage from Pemetrexed; allergic reactions and muscle pain from Paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thyroid condition is not under control.

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

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not taking any strong medications that affect liver enzymes.

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I am not pregnant and agree to use contraception during and after the study.

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My cancer has a ROS1 mutation and I haven't had targeted therapy for it.

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I have a bleeding disorder that is not under control.

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I do not have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post final enrollment in phase 1 - up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post final enrollment in phase 1 - up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post final enrollment in phase 1 - up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Recommended Phase 1b Dose

Phase 1b: Overall Response Rate (ORR)

Secondary study objectives

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Non-Squamous Cell Lung Cancer (SQCLC)Active Control3 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 Control3 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.

0 / 11Eligibility criteria met