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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study treatment to first documented disease progression per recist v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 8 years)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study treatment to first documented disease progression per recist v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 8 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study treatment to first documented disease progression per recist v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 8 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment to first documented disease progression per recist v1.1, or local or distant disease recurrence as determined by investigator, or death from any cause, whichever occurs first, through the end of study (up to 8 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

Checkpoint inhibitor (CPI) cohort: Pathological complete response (pCR)

KRAS cohort: Percentage of participants with 3-5 grade Adverse Events

KRAS cohort: Percentage of participants without delays of surgery due to treatment-related adverse events as reported by the investigator

+1 more

Secondary outcome measures

Circulating tumor DNA ctDNA Clearance Rate

Disease-Free Survival (DFS)

Event-Free Survival (EFS)

+9 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

White blood cell count decreased

14%

Vomiting

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

14%

Anaemia

14%

Neutropenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Dizziness

Back pain

Diarrhea

Musculoskeletal pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

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 CohortExperimental 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

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

Group VI: BRAF CohortExperimental 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

Vemurafenib

2015

Completed Phase 3

~3100

Alectinib

2015

Completed Phase 3

~2400

Chemotherapy

2003

Completed Phase 4

~3050

Resection

2021

Completed Phase 2

~410

Cobimetinib

2017

Completed Phase 3

~2660

Pralsetinib

2021

Completed Phase 2

~260

SBRT

2014

Completed Phase 2

~1060

Atezolizumab

2017

Completed Phase 3

~5860

Entrectinib

2014

Completed Phase 2

~360

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,540 Previous Clinical Trials

567,753 Total Patients Enrolled

Blueprint Medicines CorporationIndustry Sponsor

29 Previous Clinical Trials

6,073 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

Non-Small Cell Lung Cancer Research Study Groups: NTRK Cohort, PD-L1 Cohort, ALK Cohort, ROS 1 Cohort, KRAS G12C Cohort, RET Cohort, BRAF Cohort

Non-Small Cell 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

Frequently Asked Questions

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

What maladies are most often treated with Chemotherapy?

"Chemotherapy is a viable therapeutic option for patients experiencing solid tumors, non-small cell lung carcinoma, or unresectable melanoma."

Answered by AI

Are applicants still being taken for this research exploration?

"According to the official clinicaltrials.gov page, this trial initiated on November 6th 2020 and is actively searching for participants as of today's date (November 10th 2022)."

Answered by AI

How many medical facilities are currently undertaking this clinical trial?

"The ongoing clinical trial is accepting participants at University Hospitals Cleveland Medical Center, Ohio State University; Hemat/Onc, Moffitt Cancer Center and an additional 20 sites."

Answered by AI

To what degree is chemotherapy potentially hazardous for patients?

"Based on the Phase 2 trial data, our team at Power determined that chemotherapy should be ranked a 2 for safety; there is some evidence to support its security but none suggesting effectiveness."

Answered by AI

Are there any recorded accounts of Chemotherapy being used in prior research?

"First studied in 2012, chemotherapy has since been explored in 231 trials. Presently, 97 clinical studies are actively recruiting with many of these experiments being conducted out of Cleveland, Ohio."

Answered by AI

How many guinea pigs are involved in this experiment?

"To move ahead with this research, 80 qualified individuals must be recruited. Blueprint Medicines Corporation is handling the trial from two distinct locations: University Hospitals Cleveland Medical Center in Cleveland, Ohio and Ohio State University; Hemat/Onc in Columbus, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

2020. "A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04302025.

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