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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 4 weeks until disease progression, up to approximately 6 years
Awards & highlights

B-FAST Trial 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.Check my eligibility
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.See study design
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.

B-FAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is at an advanced stage and cannot be removed by surgery.
Select...
I am able to get out of my bed or chair and move around.

B-FAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 4 weeks until disease progression, up to approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 4 weeks until disease progression, up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
+4 more
Secondary outcome measures
All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
+43 more

B-FAST Trial Design

10Treatment groups
Experimental Treatment
Active Control
Group I: Cohort G: GDC-6036 or DocetaxelExperimental Treatment2 Interventions
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
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 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
Entrectinib
2014
Completed Phase 2
~360
Vemurafenib
2015
Completed Phase 3
~3100
Docetaxel
1995
Completed Phase 4
~5620
Bevacizumab
2013
Completed Phase 4
~5280
Pemetrexed
2014
Completed Phase 3
~5250
Cobimetinib
2017
Completed Phase 3
~2660
Alectinib
2015
Completed Phase 3
~2400
Atezolizumab
2017
Completed Phase 3
~5860
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,088,410 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,732 Total Patients Enrolled

Media Library

Alectinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03178552 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Cohort C: Pemetrexed, Cisplatin or Carboplatin, Cohort A: Alectinib 600 Milligrams (mg), Cohort C: Atezolizumab 1200 mg, Cohort C: Gemcitabine, Cisplatin or Carboplatin, Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib, Cohort G: GDC-6036 or Docetaxel, Cohort D: Entrectinib 600 Milligrams (mg), Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed, Cohort B: Dose Finding Phase (DFP) Alectinib, Cohort B: Dose Expansion Phase (DEP) Alectinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Alectinib Highlights & Side Effects. Trial Name: NCT03178552 — Phase 2 & 3
Alectinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03178552 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical condition is Atezolizumab commonly prescribed?

"Atezolizumab is not only useful for initial treatment, but it can also be employed to manage urinary bladder, small cell lung cancer (sclc), and advanced testicular cancer."

Answered by AI

Does Atezolizumab have a history of being tested in other scientific investigations?

"City of Hope Comprehensive Cancer Center first looked at atezolizumab in 1997. Out of the 3501 completed clinical trials, 2042 are still recruiting patients. The majority of these trials are based in Sacramento, California."

Answered by AI
~392 spots leftby Aug 2028