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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post final enrollment in phase 1 - up to 48 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Recommended Phase 1b Dose
Phase 1b: Overall Response Rate (ORR)
Secondary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)
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.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,444 Total Patients Enrolled
Jhanelle Gray, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
6 Previous Clinical Trials
326 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid condition is not under control.I am allergic to pirfenidone, carboplatin, pemetrexed, or paclitaxel.I have previously received immunotherapy.I am not receiving any other cancer treatments and do not have another active cancer.My brain metastases have been treated and stable for over 4 weeks.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.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.I am not taking any strong medications that affect liver enzymes.I am not pregnant and agree to use contraception during and after the study.My lung cancer is advanced and cannot be removed by surgery, and I've been tested for specific genetic mutations.Your blood test must show enough white blood cells, platelets, and hemoglobin.I haven't had immunotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.My cancer has a ROS1 mutation and I haven't had targeted therapy for it.I have a bleeding disorder that is not under control.I do not have severe nerve damage in my hands or feet.I am 18 years old or older.I haven't had chemotherapy for my stage IV lung cancer, except as part of earlier treatment that ended over 6 months ago.I can provide previous biopsy samples or am willing to have a new biopsy if needed.I agree to join the trial willingly and know I can leave at any time.I don't have any health conditions that would make the study medication unsafe for me.I am fully active or can carry out light work.You depend on alcohol or drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Non-Squamous Cell Lung Cancer (SQCLC)
- Group 2: Squamous Cell Lung Cancer (SQCLC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Non-Squamous Cell Lung Cancer (SQCLC) a hazard to human health?
"SQCLC scored a 1 since this is an early-stage trial with limited evidence of efficacy and safety."
Answered by AI
To what extent is Non-Squamous Cell Lung Cancer (SQCLC) utilized for therapeutic purposes?
"Non-Squamous Cell Lung cancer (SQCLC) is a viable therapeutic option for the management of palliative therapy, malignant peritoneal neoplasm, and advanced endometrial cancer."
Answered by AI
Is the recruitment stage of this experiment still open?
"This research endeavour is unfortunately no longer accepting participants. It was initially published on September 26th 2017 and last updated November 2nd 2022; however, there are currently 2050 trials actively seeking patients with Non-Small Cell Lung Carcinoma (NSCLC) and 1,237 studies for Squamous Cell Lung cancer (SQCLC)."
Answered by AI
How many participants are currently enrolled in this experiment?
"As of present, this clinical trial is not enrolling participants. The study was initially published on September 26th 2017 and has been updated as recently as November 2nd 2022. For those searching for alternative studies, there are currently 2050 trials actively seeking volunteers with non-small cell lung carcinoma (NSCLC) and 1237 trials recruiting individuals with Non-Squamous Cell Lung cancer (SQCLC)."
Answered by AI
How have other research studies explored the efficacy of Non-Squamous Cell Lung Cancer (SQCLC) treatments?
"Currently, there are 1237 active research projects examining Non-Squamous Cell Lung cancer (SQCLC). Of these trials, 349 have entered Phase 3. Shanghai alone has numerous clinical sites for SQCLC; in total, 70526 medical centres worldwide host studies on this cancer type."
Answered by AI
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