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A Study of Alectinib, Entrectinib, Vemurafenib Plus Cobimetinib, or Pralsetinib in Patients With Resectable Stages II-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, BRAF V600, or RET Molecular Alterations

Trial Status: Active

This trial will evaluate the efficacy and safety of targeted therapies in participants with resectable Stage IIA, IIB, IIIA, and select IIIB (T3N2) resectable and untreated non-small cell lung cancer (NSCLC) tumors with selected molecular alterations.

Inclusion Criteria

  • Inclusion Criteria for Neoadjuvant Therapy: - Pathologically documented NSCLC: Stage IIA, IIB, IIIA, or selected IIIB, including T3N2, or T4 (by size criteria, not by mediastinal invasion) NSCLC (based on the 8th edition of the American Joint Committee on Cancer [AJCC] Non-Small Cell Lung Cancer Staging system - Molecular testing results from CLIA-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion; BRAF V600 mutation; RET fusion - Measurable disease, as defined by RECIST v1.1 - 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 - Adequate pulmonary function to be eligible for surgical resection with curative intent - Adequate cardiac function to be eligible for surgical resection with curative intent - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Male participants must be willing to use acceptable methods of contraception - Female participants of childbearing potential must agree to use acceptable methods of contraception Inclusion Criteria for Adjuvant Therapy - Participants whose tumors lack radiographic progression - ECOG Performance Status of 0 or 1 - Adequate hematologic and end-organ function Exclusion Criteria - NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by virtue of N3 disease - Any prior therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 2 years - Participants with prior lung cancer that have been in remission for <2 years with the exception of minimally invasive adenocarcinoma or incidental typical carcinoid tumors - Major surgical procedure within 28 days prior to Cycle 1, Day 1 - Participants known to be positive for HIV are excluded if they meet any of the following criteria: CD4+ T-cell count of <350 cells/microliters; detectable HIV viral load; history of an opportunistic infection within the past 12 months; on stable antiretroviral therapy for <4 weeks - Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infections, or any active infection that, in the opinion of the investigator, could impact participant safety - Pregnant or lactating, or intending to become pregnant during the study

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Grace M Facio
Phone: 323-409-7027ext3511
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Grace M Facio
Phone: 323-409-7027ext3511
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Jamie Erin Chaft
Phone: 646-888-4545
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Genentech Inc.

  • Primary ID ML41591
  • Secondary IDs NCI-2020-01859
  • Clinicaltrials.gov ID NCT04302025