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Tyrosine Kinase Inhibitor

Targeted Therapy for Lung Cancer (B-FAST Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dfp: pre-dose (0 hours [hr]) on day 1 of cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on day 1 of cycle 2 (1 cycle=28 days)

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who haven't had recent cancer treatments and are in fairly good health. They should be able to perform daily activities with ease to moderate difficulty, have a life expectancy of at least 12 weeks, and agree to use contraception.

What is being tested?

The study tests various targeted therapies and immunotherapies—either alone or combined—for NSCLC. These include Alectinib, Atezolizumab, Pemetrexed, among others. The effectiveness of these treatments will be measured by their ability to shrink tumors or slow disease progression.

What are the potential side effects?

Potential side effects may include fatigue, nausea, skin reactions, increased risk of infections due to immune system suppression by the drugs tested like Atezolizumab and Bevacizumab; organ-specific toxicity such as liver or kidney issues from agents like Cisplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at an advanced stage and cannot be removed by surgery.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart issues like recent heart attacks or unstable angina.

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I am HIV positive or have an AIDS-related illness.

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I cannot swallow pills.

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I am not pregnant or breastfeeding.

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I have brain metastases that haven't been treated and are causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dfp: pre-dose (0 hours [hr]) on day 1 of cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on day 1 of cycle 2 (1 cycle=28 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dfp: pre-dose (0 hours [hr]) on day 1 of cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on day 1 of cycle 2 (1 cycle=28 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and dfp: pre-dose (0 hours [hr]) on day 1 of cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on day 1 of cycle 2 (1 cycle=28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Group I: Cohort G: Divarasib or DocetaxelExperimental Treatment2 Interventions

Experimental: Cohort G: GDC-6036 or Docetaxel This cohort includes participants with KRAS G12C mutation. Participants will receive GDC-6036 PO QD or IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity New participants will no longer receive docetaxel.

Group II: Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and PemetrexedExperimental Treatment4 Interventions

This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death. Enrollment to Cohort F is complete.

Group III: Cohort E: Atezolizumab, Vemurafenib, and CobimetinibExperimental Treatment3 Interventions

This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period. Enrollment to Cohort E is complete.

Group IV: Cohort D: Entrectinib 600 Milligrams (mg)Experimental Treatment1 Intervention

This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort D is complete.

Group V: Cohort C: Atezolizumab 1200 mgExperimental Treatment1 Intervention

This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort C is complete.

Group VI: Cohort B: Dose Finding Phase (DFP) AlectinibExperimental Treatment1 Intervention

This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose. Enrollment to Cohort B is complete.

Group VII: Cohort B: Dose Expansion Phase (DEP) AlectinibExperimental Treatment1 Intervention

This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort B is complete.

Group VIII: Cohort A: Alectinib 600 Milligrams (mg)Experimental Treatment1 Intervention

This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort A is complete.

Group IX: Cohort C: Pemetrexed, Cisplatin or CarboplatinActive Control3 Interventions

This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m\^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care. Enrollment to Cohort C is complete.

Group X: Cohort Z: Natural History CohortActive Control1 Intervention

Participants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.

Group XI: Cohort C: Gemcitabine, Cisplatin or CarboplatinActive Control3 Interventions

This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m\^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D. Enrollment to Cohort C is complete.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3550

Alectinib

2019

Completed Phase 3

~2810