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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the drug Pirfenidone, combined with standard chemotherapy, affects individuals with advanced non-small cell lung cancer (NSCLC). Pirfenidone is already used for idiopathic pulmonary fibrosis, but its effects on lung cancer remain unknown. The trial includes two groups: one for squamous cell lung cancer and another for non-squamous cell lung cancer, each receiving a combination of Pirfenidone and chemotherapy (including drugs like Carboplatin and Paclitaxel). This trial may suit those diagnosed with advanced NSCLC who have not yet undergone chemotherapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants taking certain medications that affect liver enzymes (CYP1A2 inhibitors). It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using pirfenidone with carboplatin-based chemotherapy might be a safe option for treating non-small cell lung cancer (NSCLC). Studies have examined this combination in patients with both lung cancer and idiopathic pulmonary fibrosis, a lung disease that causes scarring. These studies suggest that this treatment is generally well-tolerated.

For those receiving pirfenidone with carboplatin and pemetrexed, the combination seems safe as an initial treatment for the cancer. Similarly, studies indicate that pirfenidone with carboplatin and paclitaxel also appears to be a safe option.

It's important to note that while pirfenidone is approved for another lung condition, it is still being tested for safety in lung cancer treatments. This trial aims to assess how well people tolerate this combination. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard of care for lung cancer, which typically involves chemotherapy drugs like carboplatin, paclitaxel, and pemetrexed, the investigational treatment combines these with pirfenidone. Pirfenidone is particularly exciting because it is traditionally used to treat lung fibrosis and is believed to have anti-fibrotic and anti-inflammatory properties. Researchers are curious to see if adding pirfenidone can enhance the effectiveness of chemotherapy by potentially reducing tumor growth and improving outcomes for both squamous and non-squamous cell lung cancer patients. This unique approach could offer new hope by tackling the cancer with a dual-action strategy that current treatments don't employ.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial examines two different treatment combinations for non-small cell lung cancer (NSCLC). One arm combines pirfenidone with carboplatin and pemetrexed, while the other combines pirfenidone with carboplatin and paclitaxel. Studies have shown that pirfenidone with carboplatin-based treatments could be a safe initial option for NSCLC, especially for patients with idiopathic pulmonary fibrosis (IPF). Research suggests that both combinations might be effective and could enhance treatment outcomes for NSCLC. Current evidence supports the potential benefit of these combinations for NSCLC patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Jhanelle Gray, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

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.

My brain metastases have been treated and stable for over 4 weeks.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7606001/

Safety and effectiveness of pirfenidone combined with ... The present study found that pirfenidone combined with carboplatin‐based regimens or ICIs might be safe first‐line chemotherapy for patients with IPF and NSCLC.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32986306/

Safety and effectiveness of pirfenidone combined with ... The present study found that pirfenidone combined with carboplatin-based regimens or ICIs might be safe first-line chemotherapy for patients with IPF and NSCLC.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/1759-7714.13675

Safety and effectiveness of pirfenidone combined with ... Safety and efficacy of S-1 in combination with carboplatin in non-small cell lung cancer patients with interstitial lung disease: A pilot study.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03177291

Study Details | NCT03177291 | Pirfenidone Combined With ... 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 ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016950021000173X

The safety and efficacy of weekly paclitaxel in combination ... Weekly paclitaxel and carboplatin combination chemotherapy was as effective as conventional regimens in advanced NSCLC patients without IIP and was safer than ...

6. researchgate.net researchgate.net/publication/344423987_Safety_and_effectiveness_of_pirfenidone_combined_with_carboplatin-based_chemotherapy_in_patients_with_idiopathic_pulmonary_fibrosis_and_non-small_cell_lung_cancer_A_retrospective_cohort_study

(PDF) Safety and effectiveness of pirfenidone combined ... Results: Median PFS for lung cancer was 110 days (95% confidence interval [CI]: 57-199 days), while the median OS was 362 days (95% CI: 220-526 ...