Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 66
Summary
- Conditions
- Advanced Cancer
- Lung Cancer
- Metastatic Lung Cancer
- Non -Small Cell Lung Cancer
- Non-Squamous Non-Small Cell Neoplasm of Lung
- Squamous Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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-es...
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.
Tracking Information
- NCT #
- NCT03177291
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jhanelle Gray, M.D. H. Lee Moffitt Cancer Center and Research Institute
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