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Kinase Inhibitor

Combination Therapy for Lung Cancer

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable
Must not have
Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years
NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after surgical resection (approximately study week 8)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing different therapies to see which is most effective and safe to treat patients with NSCLC tumors.

Who is the study for?
This trial is for adults with resectable, untreated Stage IB-III non-small cell lung cancer (NSCLC) that have specific biomarkers. They must be medically fit for surgery, have good organ function and performance status, and not have had any prior lung cancer treatments in the last 2 years. Participants should agree to use contraception and cannot join if they've had major surgery recently or other cancers within 3 years.
What is being tested?
The study tests multiple therapies including Divarasib, Vemurafenib, Alectinib, Chemotherapy, Resection (surgery), Cobimetinib, Pralsetinib, SBRT (a type of radiation therapy), Atezolizumab (immunotherapy), and Entrectinib on patients with NSCLC who meet certain genetic criteria. The goal is to see which treatment works best.
What are the potential side effects?
Possible side effects include reactions related to the immune system from drugs like Atezolizumab; skin issues from targeted therapies like Vemurafenib; liver changes due to Divarasib; fatigue from chemotherapy; surgical complications from resection; and tissue damage from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My surgeon confirmed I can have surgery to remove my cancer completely.
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I have been tested for hepatitis B, and either don't have it or it's not currently active.
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My cancer has one of the specific genetic changes listed.
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I am fully active or can carry out light work.
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My heart is healthy enough for surgery aimed at curing my condition.
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My lungs work well enough for surgery to remove my cancer.
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I am willing to use contraception.
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My lung cancer is at a specific stage (IB, IIA, IIB, IIIA, or some IIIB).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had lung cancer treatment in the last 2 years.
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My lung cancer has spread to the middle of my chest or to lymph nodes far from the tumor.
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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgical resection (approximately study week 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgical resection (approximately study week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Checkpoint inhibitor (CPI) cohort: Pathological complete response (pCR)
Tyrosine kinase inhibitor (TKI) cohort: Proportion of Participants with Major Pathologic Response (MPR)
Secondary study objectives
Pathological Complete Response (pCR) as Assessed by Local and Central Pathology Laboratories
Proportion of Participants with MPR
Proportion of Participants with pCR

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
Alanine aminotransferase increased
14%
White blood cell count decreased
14%
Thrombocytopenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Group I: ROS 1 CohortExperimental Treatment3 Interventions
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per standard of care. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the Adjuvant Treatment Phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Group II: RET Cohort (Enrollment closed)Experimental Treatment3 Interventions
Participants will receive up to 8 weeks of pralsetinib neoadjuvant treatment before undergoing surgical resection per standard of care. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the Adjuvant Treatment Phase with pralsetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of pralsetinib. Enrollment closed.
Group III: PD-L1 CohortExperimental Treatment3 Interventions
Participants with positive PD-L1 in ≥1% tumor cells will receive 4 cycles of atezolizumab neoadjuvant treatment. During neoadjuvant Cycle 1 of atezolizumab, patients will also receive low-dose SBRT (8Gy X 3). Adjuvant treatment consists of SOC treatment as determined by the investigator, per NCCN guidelines
Group IV: NTRK CohortExperimental Treatment3 Interventions
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per standard of care. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the Adjuvant Treatment Phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Group V: KRAS G12C CohortExperimental Treatment2 Interventions
Participants will receive up to 8 weeks of divarasib as neoadjuvant treatment before undergoing surgical resection per standard of care. PD-L1 negative patients whose tumors have pathological response or lack radiographic progression will be have the option of continuing divarasib for up to 2 years as adjuvant therapy. For patients who test positive PD-L1, they will have the option to receive Atezolizumab for up to 16 cycles.
Group VI: BRAF Cohort (Enrollment closed, no participants enrolled)Experimental Treatment4 Interventions
Participants will receive up to 8 weeks of vemurafenib plus cobimetinib neoadjuvant treatment before undergoing surgical resection per standard of care. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the Adjuvant Treatment Phase with vemurafenib plus cobimetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of of vemurafenib plus cobimetinib. Enrollment closed.
Group VII: ALK CohortExperimental Treatment3 Interventions
Participants will receive up to 8 weeks of alectinib neoadjuvant treatment before undergoing surgical resection per standard of care. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the Adjuvant Treatment Phase with alectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of alectinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
2019
Completed Phase 3
~2810
Chemotherapy
2003
Completed Phase 4
~3050
Resection
2023
Completed Phase 2
~420
SBRT
2014
Completed Phase 2
~1060
Atezolizumab
2016
Completed Phase 3
~5860
Entrectinib
2014
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,558 Previous Clinical Trials
569,311 Total Patients Enrolled
Blueprint Medicines CorporationIndustry Sponsor
29 Previous Clinical Trials
6,083 Total Patients Enrolled
Chugai Pharmaceutical Co.UNKNOWN
3 Previous Clinical Trials
276 Total Patients Enrolled

Media Library

Alectinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04302025 — Phase 2
Lung Cancer Research Study Groups: PD-L1 Cohort, RET Cohort (Enrollment closed), NTRK Cohort, BRAF Cohort (Enrollment closed, no participants enrolled), ALK Cohort, ROS 1 Cohort, KRAS G12C Cohort
Lung Cancer Clinical Trial 2023: Alectinib Highlights & Side Effects. Trial Name: NCT04302025 — Phase 2
Alectinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04302025 — Phase 2
~27 spots leftby Dec 2025