Cancer
Conditions
Interventions
Cohort F Atezolizumab Bevacizumab Carboplatin and Pemetrexed
Cohort G GDC 6036
Cohort G Docetaxel
Sponsors
Hoffmann La Roche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) ] 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
| Measure | Time frame |
|---|---|
| -All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ] -Cohorts A, B, D, F, G: PFS as Assessed by the Investigator Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ] -Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ] -Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ] -Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1 [ Time Frame: Baseline up to disease progression or death (up to approximately 6 years) ] -All Cohorts: Overall Survival (OS) [ Time Frame: Baseline up to approximately 6 years ] -All Cohorts: Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to approximately 6 years ] ;-Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ] -Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years ] -Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale [ Time Frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or | — |
Countries
Kenya
Contacts
Public ContactTamara Talhouk
Interim Clinical Operations Lead Clinical Operations Network Area Africa
Outcome results
None listed