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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ after surgical resection (approximately study week 8)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgical resection (approximately study week 8)
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 • NCT0200053129%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not have hepatitis C virus (HCV) or it should not be active in your body.I am fully active or can carry out light work.My blood and organs are functioning well.My surgeon confirmed I can have surgery to remove my cancer completely.I haven't had lung cancer treatment in the last 2 years.I agree to use birth control if I can have children.I have been tested for hepatitis B, and either don't have it or it's not currently active.I haven't had any other cancers in the last 3 years, except for those with a low risk and curable outcome.My cancer has one of the specific genetic changes listed.You have a disease that can be measured using specific guidelines.I am HIV positive but do not meet any of the exclusion criteria.My lung cancer is classified as T4 based on its size.I am fully active or can carry out light work.I have not had a severe infection or been hospitalized for one in the last 4 weeks.Your tumor has not shown any growth on imaging tests.My heart is healthy enough for surgery aimed at curing my condition.I will have CT, PET scans, and an MRI of the brain for cancer staging.My lung cancer has spread to the middle of my chest or to lymph nodes far from the tumor.I have not had major surgery in the last 28 days.My previous lung cancer has been in remission for less than 2 years, except for certain less aggressive types.My lungs work well enough for surgery to remove my cancer.I am willing to use contraception.My lung cancer is at a specific stage (IB, IIA, IIB, IIIA, or some IIIB).You tested negative for hepatitis B surface antigen.
Research Study Groups:
This trial has the following groups:- Group 1: PD-L1 Cohort
- Group 2: RET Cohort (Enrollment closed)
- Group 3: NTRK Cohort
- Group 4: BRAF Cohort (Enrollment closed, no participants enrolled)
- Group 5: ALK Cohort
- Group 6: ROS 1 Cohort
- Group 7: KRAS G12C Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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