A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST)
- Conditions
- Cancer
- Registration Number
- PACTR202211687583152
- Lead Sponsor
- Hoffmann La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 682
Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
-Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
-Measurable disease
-Adequate recovery from most recent systemic or local treatment for cancer
-Adequate organ function
-Life expectancy greater than or equal to (>/=) 12 weeks
-For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception
-Inability to swallow oral medication
-Women who are pregnant or lactating
-Symptomatic, untreated CNS metastases
-History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
-Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
-Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
-Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
-Inability to comply with other requirements of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]<br>Cohort G: PFS as Determined by Blinded Independent Central Review (BICR) Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ]
- Secondary Outcome Measures
Name Time Method