Study Summary
This trial is designed to study the safety and effectiveness of different cancer treatments in people with NSCLC that can't be removed by surgery and have certain oncogenic mutations or high TMB.
Eligible Conditions
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 55 Secondary · Reporting Duration: Baseline, every 4 weeks until disease progression, up to approximately 6 years
Year 6
Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1
Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1
Year 6
All Cohorts: Overall Survival (OS)
All Cohorts: Percentage of Participants with Adverse Events (AEs)
Cohort C: OS in bTMB PP2
Cohort E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Cohort G: Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
Cohort G: TTCD on the EORTC QLQ-C30 Physical Functioning and Role Functioning Scales
Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC
Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)
Year 6
All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
All Cohorts: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
All Cohorts: PFS as Assessed by IRF Based on RECIST v1.1
All Cohorts: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2
Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
Cohort G: PFS as Determined by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
Cohorts A, B, D, F, G: PFS as Assessed by the Investigator Based on RECIST v1.1
Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1
Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1
Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
Year 6
All Cohorts: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
All Cohorts: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
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)
Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
Year 6
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
Cohorts D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
Day 28
Cohort G: Change from Baseline in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Cohort G: Proportion of Participants Reporting Clinically Meaningful Deterioration in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Day 21
Cohort G: Tolerability of GDC-6036 or Docetaxel as Assessed by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Day 21
Cohort G: Plasma Concentration of GDC-6036
Day 28
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
Day 28
Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
Cohort B: Half-Life (t1/2) of Alectinib
Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
Cohort B: Metabolite to Parent Exposure Ratio for Cmax
Cohort B: Time to Reach Cmax (Tmax) of Alectinib
Day 28
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Month 12
Cohort E: TIR as Assessed by IRF
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Month 9
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
Months 6, 12
Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12
Day 28
Cohorts E, F: Serum Concentration of Atezolizumab
Day 28
Cohort D: Mean Plasma Concentration of Entrectinib
Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
10 Treatment Groups
Cohort C: Pemetrexed, Cisplatin or Carboplatin
1 of 10
Cohort C: Gemcitabine, Cisplatin or Carboplatin
1 of 10
Cohort D: Entrectinib 600 Milligrams (mg)
1 of 10
Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib
1 of 10
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed
1 of 10
Cohort G: GDC-6036 or Docetaxel
1 of 10
Cohort C: Atezolizumab 1200 mg
1 of 10
Cohort A: Alectinib 600 Milligrams (mg)
1 of 10
Cohort B: Dose Expansion Phase (DEP) Alectinib
1 of 10
Cohort B: Dose Finding Phase (DFP) Alectinib
1 of 10
Active Control
Experimental Treatment
1000 Total Participants · 10 Treatment Groups
Primary Treatment: Atezolizumab · No Placebo Group · Phase 2 & 3
Cohort D: Entrectinib 600 Milligrams (mg)
Drug
Experimental Group · 1 Intervention: Entrectinib · Intervention Types: DrugCohort E: Atezolizumab, Vemurafenib, and CobimetinibExperimental Group · 3 Interventions: Atezolizumab, Cobimetinib, Vemurafenib · Intervention Types: Drug, Drug, Drug
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and PemetrexedExperimental Group · 4 Interventions: Atezolizumab, Pemetrexed, Carboplatin, Bevacizumab · Intervention Types: Drug, Drug, Drug, Drug
Cohort G: GDC-6036 or DocetaxelExperimental Group · 2 Interventions: GDC-6036, Docetaxel · Intervention Types: Drug, Drug
Cohort C: Atezolizumab 1200 mg
Drug
Experimental Group · 1 Intervention: Atezolizumab · Intervention Types: DrugCohort A: Alectinib 600 Milligrams (mg)
Drug
Experimental Group · 1 Intervention: Alectinib · Intervention Types: DrugCohort B: Dose Expansion Phase (DEP) Alectinib
Drug
Experimental Group · 1 Intervention: Alectinib · Intervention Types: DrugCohort B: Dose Finding Phase (DFP) Alectinib
Drug
Experimental Group · 1 Intervention: Alectinib · Intervention Types: DrugCohort C: Pemetrexed, Cisplatin or CarboplatinActiveComparator Group · 3 Interventions: Pemetrexed, Cisplatin, Carboplatin · Intervention Types: Drug, Drug, Drug
Cohort C: Gemcitabine, Cisplatin or CarboplatinActiveComparator Group · 3 Interventions: Cisplatin, Carboplatin, Gemcitabine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
FDA approved
Atezolizumab
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Entrectinib
FDA approved
Bevacizumab
FDA approved
Cobimetinib
FDA approved
Vemurafenib
FDA approved
Docetaxel
1995
Completed Phase 4
~8840
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, every 4 weeks until disease progression, up to approximately 6 years
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,360 Previous Clinical Trials
1,066,641 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,146 Previous Clinical Trials
874,695 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have adequate organ function.
You have a performance status of 0-2.
You have had no recurrence of cancer for at least 3 years.
You are willing to use acceptable methods of contraception.
References
- Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22.
- 2017. "A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03178552.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments