Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC (NCT03177291) | Clinical Trial Compass
CompletedPhase 1
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
United States48 participantsStarted 2017-09-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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 receive…
What they're measuring
1
Phase 1: Recommended Phase 1b Dose
Timeframe: 6 months post final enrollment in phase 1 - up to 48 months
2
Phase 1b: Overall Response Rate (ORR)
Timeframe: 6 months post final enrollment in phase 1b - up to 48 months
Trial details
NCT IDNCT03177291
SponsorH. Lee Moffitt Cancer Center and Research Institute