Lung CancerPhase 1NCT03177291

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

A Phase 1 study testing Pirfenidone, Carboplatin and Paclitaxel in people with Lung Cancer and Non Small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Non Small Cell Lung Cancer, Advanced Cancer
What is being tested?: Pirfenidone, Carboplatin and Paclitaxel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2017to 4 Dec 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I/Ib Trial of Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

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.

Read the detailed description

This study will be conducted in two phases: 1) a Phase I dose escalation study with a Standard 3+3 design to determine the recommended Phase II dose and 2) a Phase Ib expansion study to evaluate early signs of efficacy and obtain more toxicity data. The Phase I trial will be a single center, dose-escalation study of pirfenidone combined with standard chemotherapy in the treatment of advanced/metastatic NSCLC, followed by a Phase Ib trial to determine early clinical efficacy [objective tumor response rate (ORR)] and toxicity data.

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
Being tested: Pirfenidone, Carboplatin, Paclitaxel, Pemetrexed
Keywords: NSCLC, SCLC
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PirfenidoneDrug
Also called 5-methyl-1-phenyl-1H-pyridine-one, Esbriet
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.
CarboplatinDrug
Also called Paraplatin
Area under the curve (AUC) 6 on Day 1 of a 21-day cycle for 4 - 6 cycles.
PaclitaxelDrug
Also called Abraxane
200 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.
PemetrexedDrug
Also called Alimta
500 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.

Study groups in NCT03177291
Study group	Role	What they receive
Squamous Cell Lung Cancer (SQCLC)	Active comparator	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. Receives: Drug: Pirfenidone; Drug: Carboplatin; Drug: Paclitaxel
Non-Squamous Cell Lung Cancer (SQCLC)	Active comparator	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. Receives: Drug: Pirfenidone; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1: Recommended Phase 1b Dose
Recommended Phase 1b dose of Pirfenidone in combination with standard first-line chemotherapy, based on Dose Limiting Toxicity (DLT) from phase 1. Dose-limiting Toxicity: The occurrence of any of the following toxicities will be considered a DLT, if judged by the Investigator to be possibly, probably, or definitely related to study drug administration, referring to grade 3-5 adverse events as listed in the protocol document.
Measured: 6 months post final enrollment in phase 1 - up to 48 months
Phase 1b: Overall Response Rate (ORR)
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete Response (CR) plus Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 6 months post final enrollment in phase 1b - up to 48 months

Secondary outcomes (2)

Progression Free Survival (PFS)
PFS according to RECIST 1.1: defined as the time from study registration to progression or death, whichever comes first. PFS for patients last known to be alive and progression free will be censored at the date of last disease assessment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm).
(Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: Up to 48 months
Overall Survival (OS)
Overall survival (OS) defined as the time from study registration or death due to any cause. OS for patients last known to be alive will be censored at the date of last contact.
Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 20174 Dec 2024

First posted6 Jun 2017
Study start26 Sep 2017
Primary completion9 May 2021
Study completion4 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03177291
Sponsor's protocol ID: MCC-19082
Status last verified: Dec 2025
First submitted: 2 Jun 2017
Last updated: 5 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/Ib Trial of Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
ClinicalTrials.gov ID: NCT03177291
Acronym / sponsor ID: MCC-19082
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
Keywords: NSCLC, SCLC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
Study start: 26 Sep 2017 (actual)
Primary completion: 9 May 2021 (actual)
Study completion: 4 Dec 2024 (actual)
First posted: 6 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Squamous Cell Lung Cancer (SQCLC)	Active comparator	Drug: Pirfenidone, Drug: Carboplatin, Drug: PaclitaxelArm 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.
Non-Squamous Cell Lung Cancer (SQCLC)	Active comparator	Drug: Pirfenidone, Drug: Carboplatin, Drug: PemetrexedArm 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PirfenidoneAlso: 5-methyl-1-phenyl-1H-pyridine-one, EsbrietPirfenidone: 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	Non-Squamous Cell Lung Cancer (SQCLC), Squamous Cell Lung Cancer (SQCLC)
CarboplatinAlso: ParaplatinArea under the curve (AUC) 6 on Day 1 of a 21-day cycle for 4 - 6 cycles.	Drug	Non-Squamous Cell Lung Cancer (SQCLC), Squamous Cell Lung Cancer (SQCLC)
PaclitaxelAlso: Abraxane200 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.	Drug	Squamous Cell Lung Cancer (SQCLC)
PemetrexedAlso: Alimta500 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.	Drug	Non-Squamous Cell Lung Cancer (SQCLC)

Primary outcome

Phase 1: Recommended Phase 1b Dose
Time frame: 6 months post final enrollment in phase 1 - up to 48 months
Recommended Phase 1b dose of Pirfenidone in combination with standard first-line chemotherapy, based on Dose Limiting Toxicity (DLT) from phase 1. Dose-limiting Toxicity: The occurrence of any of the following toxicities will be considered a DLT, if judged by the Investigator to be possibly, probably, or definitely related to study drug administration, referring to grade 3-5 adverse events as listed in the protocol document.
Phase 1b: Overall Response Rate (ORR)
Time frame: 6 months post final enrollment in phase 1b - up to 48 months
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete Response (CR) plus Partial Response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

2 secondary outcomes

Progression Free Survival (PFS)
Time frame: Up to 48 months
Overall Survival (OS)
Time frame: Up to 48 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.

Related trials for Lung Cancer

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jhanelle Gray, M.D. principal investigator

H. Lee Moffitt Cancer Center and Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Recommended Phase 1b Dose (time frame: 6 months post final enrollment in phase 1 - up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03177291.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.