A Study of Alectinib, Entrectinib, or Vemurafenib Plus Cobimetinib in Participants With Stages I-III Non-Small Cell Lung Cancer With ALK, ROS1, NTRK, or BRAF v600E Molecular Alterations

  • Cancer
  • Lung Cancer
  • Non‑Small Cell Lung Cancer (NSCLC)
  • Non Small Cell Lung Carcinoma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Cities
  • Ann Arbor
  • Aurora
  • Boston
  • Chicago
  • Columbia
  • Columbus
  • Duarte
  • Fairfax
  • Farmington Hills
  • Geneva
  • Houston
  • Irvine
  • kingwood
  • Lebanon
  • Los Angeles
  • Memphis
  • Nashville
  • New Haven
  • New York
  • Orange
  • Pittsburgh
  • Rochester
  • Sacramento
  • Saint Louis
  • San Francisco
  • Seattle
  • Tampa
  • Warrenville
  • Washington
Trial Identifier:

NCT04302025 ML41591

  • AHN Cancer Institute ? Allegheny General Hospital

    Recruiting

    314 E North Ave15212PittsburghUnited States
  • Baptist Clinical Research Institute

    Recruiting

    6025 Walnut Grove Rd38120MemphisUnited States
  • Baylor College of Medicine

    Recruiting

    1 Baylor Plz77030HoustonUnited States
  • Boston Medical Center

    Recruiting

    One Boston Medical Center Pl02118BostonUnited States
  • City of Hope - Orange County Lennar Foundation Cancer Center

    Recruiting

    1000 Fivepoint92618IrvineUnited States
  • City of Hope Comprehensive Cancer Center

    Recruiting

    1500 E Duarte Rd91010DuarteUnited States
  • Columbia University Medical Center

    Recruiting

    177 Fort Washington Ave10032New YorkUnited States
  • Dana-Farber Cancer Institute

    Recruiting

    02115BostonUnited States
  • Dartmouth Hitchcock Medical Center

    Recruiting

    30 Lafayette St03756LebanonUnited States
  • Kelsey Seybold Clnic

    Recruiting

    2727 W Holcombe Blvd77025HoustonUnited States
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    Recruiting

    160 E 34th St10016New YorkUnited States
  • Mayo Clinic

    Recruiting

    200 1st St SW55905RochesterUnited States
  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

    Recruiting

    3800 Reservoir Rd NW20007WashingtonUnited States
  • Memorial Sloan Kettering Cancer Center

    Recruiting

    10065New YorkUnited States
  • Moffitt Cancer Center

    Recruiting

    12902 USF Magnolia Drive33612TampaUnited States
  • Northwestern University

    Recruiting

    300 E Superior St60611ChicagoUnited States
  • Ohio State University

    Recruiting

    281 W Lane Ave43210ColumbusUnited States
  • Siteman Cancer Center - Washington University Medical Campus

    Recruiting

    4901 Forest Park Ave63108Saint LouisUnited States
  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

    Recruiting

    1000 W La Veta Ave92868OrangeUnited States
  • UC Davis Comprehensive Cancer Center

    Recruiting

    2279 45th St95817SacramentoUnited States
  • UCLA Hematology Oncology

    Recruiting

    90095Los AngelesUnited States
  • UCSF

    Recruiting

    1701 Divisadero St94115San FranciscoUnited States
  • University of Colorado Anschutz Medical Campus

    Recruiting

    13001 E 17th Pl80045AuroraUnited States
  • University of Michigan

    Recruiting

    500 S State St48109Ann ArborUnited States
  • University of Missouri Health Care

    Recruiting

    1 Hospital Dr65212ColumbiaUnited States
  • University of Texas MD Anderson Cancer Center

    Recruiting

    77030-4008
  • Virginia Cancer Specialists

    Recruiting

    8613 US-2922031FairfaxUnited States
  • Yale Cancer Center

    Recruiting

    333 Cedar St06520New HavenUnited States
  • Cedars-Sinai Medical Center

    Withdrawn

    8700 Beverly Blvd90048Los AngelesUnited States
  • City of Hope Comprehensive Cancer Center

    Withdrawn

    1500 E Duarte Rd91010DuarteUnited States
  • Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center

    Withdrawn

    31995 Northwestern Hwy48334Farmington HillsUnited States
  • Lumi Research

    Withdrawn

    22751 Professional Dr77339kingwoodUnited States
  • Northwestern Medicine Cancer Center Delnor

    Withdrawn

    304 S Randall Rd60134GenevaUnited States
  • Northwestern Medicine Cancer Center Kishwaukee

    Withdrawn

    10 Health Services Dr60115
  • Northwestern Medicine Cancer Center Warrenville

    Withdrawn

    4405 Weaver Pkwy60555WarrenvilleUnited States
  • Seattle Cancer Care Alliance

    Withdrawn

    820 Yale Ave N98109SeattleUnited States
  • Tennessee Oncology - Nashville

    Withdrawn

    250 25th Ave N37203NashvilleUnited States
  • University Hospitals Cleveland Medical Center

    Withdrawn

    44016
  • USC Norris Cancer Center

    Withdrawn

    1441 Eastlake Ave90033Los AngelesUnited States
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria

    Genentech, Inc. Sponsor
    Phase 2 Phase
    NCT04302025, ML41591 Trial Identifier
    Alectinib, Entrectinib, Vemurafenib (Enrollment closed), Cobimetinib (Enrollment closed), Pralsetinib (Enrollment closed), Atezolizumab, SBRT, Resection, Chemotherapy, Divarasib Treatments
    Non-small Cell Lung Cancer Condition
    Official Title

    NAUTIKA1: Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

    Eligibility Criteria

    All Gender
    ≥18 Years Age
    No Healthy Volunteers
    Inclusion Criteria

    Inclusion Criteria for Neoadjuvant Therapy:

    • Pathologically documented NSCLC:
    • Newly diagnosed early-stage NSCLC stages IB, IIA, IIB, IIIA, or selected IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the American Joint Committee on Cancer (AJCC)/Union Internationale Contre le Cancer (UICC) NSCLC staging system.
    • T4 primary NSCLC will be allowed only on the basis of size. Invasion of the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, and separate tumor nodules in a different ipsilateral lobe is not permitted.
    • All patients will undergo clinical staging using CT and PET scanning, as well as brain imaging using MRI. Invasive mediastinal staging by either mediastinoscopyor endo- bronchial ultrasonography is highly encouraged for patients with radiographically suspected mediastinal nodal disease (ie, N2) but not mandated if the CT or PET scans showed no evidence of N2 disease.
    • 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 (enrollment closed); RET fusion (enrollment closed), PD-L1, KRAS G12C expression in ≥ 1% tumor cells as determined by FDA-approved test.
    • Measurable disease, as defined by RECIST v1.1
    • NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component.
    • 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
    • Adequate hematologic and end-organ function
    • Negative hepatitis B surface antigen (HBsAg) test at screening for cohort
    • Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
    • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
    • 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 (TKI Cohorts and KRAS G12C cohort [if continuing on Divarasib]):

    • 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
    • Major surgical procedure within 28 days prior to Cycle 1, Day 1
    • Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of patients with a negligible risk of metastasis or death and with expected curative outcome
    • Treatment with an investigational agent for any condition within 4 weeks 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

    About Clinical Research

    What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

    Find out now