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

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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPirfenidone and Carboplatin

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 5, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied: Drug: Pirfenidone; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically/cytologically documented Stage IIIB to Stage IV unresectable non-small cell lung cancer (either squamous cell carcinoma or non-squamous cell lung cancer or mixed histology; epidermal growth factor (EGFR) or ALK mutation excluded unless previously treated with a TKI, given a 2 week washout period). Patients with adenocarcinoma must have been tested for EGFR and ALK mutations.
At least one measurable tumor lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
18 years of age and older.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Participants should be chemotherapy naïve in the Stage IV NSCLC setting, with the exception of chemotherapy for neoadjuvant or adjuvant treatment that completed at least 6 months before the study treatment.
Participants' blood test must meet the following requirements: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; Platelets ≥ 100 x 10\^9/L; Hemoglobin level ≥ 9 g/dL.
Clinical biochemistry examination must meet the following requirements: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 X ULN for patients with liver metastases; Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 50 mL/min/m\^2; Total bilirubin ≤ 1.5 x ULN; Urine pregnancy test is negative for women of childbearing potential, within 14 days before study treatment.
Estimated life expectancy of at least 6 months.
May have received prior immunotherapy.
Have archived tissue available or be willing to undergo a fresh biopsy during screening, if deemed feasible by the investigator/study PI. If neither available, the patients enrollment must be reviewed and approved by the PI.
Voluntarily participate in the clinical trial, understanding they may withdraw participation at any time.
Able to understand and provide written informed consent prior to trial participation.

Reasons someone may not be able to joinExclusion criteria

Are currently undergoing other anti-tumor therapies or have concurrent active cancer.
Patients who were enrolled into any other treatment clinical trial and received treatment on that trial within 4 weeks of study treatment.
Any clinical laboratory findings give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
Patients with previously untreated brain metastases should be excluded. Patients with treated and stable (\>4 weeks) brain metastases may be eligible for enrollment.
History of allergic reactions to carboplatin or paclitaxel.
Have had immunotherapy or radiotherapy within 4 weeks prior to study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to study treatment. Prior history of palliative radiation for symptomatic bony or brain metastases is permissible.
Are receiving any other investigational agents.
Patients with known ROS1 mutations who have not received prior targeted therapy.
Alcohol or drug dependence.
Uncontrolled coagulopathy.
Uncontrolled hyper- or hypothyroidism.
Known hypersensitivity to pirfenidone, carboplatin, pemetrexed or paclitaxel.
Pre-existing peripheral neuropathy of Grade II or higher.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III/IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients receiving any medications or substances that are moderate to strong inhibitors CYP1A2 are ineligible.
Pregnant women are excluded from this study. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2025. Always confirm current availability with the study team.

View original record ↗