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

  • Non-Small Cell Lung Cancer
Trial Status:


This trial runs in
  • Ann Arbor
  • Aurora
  • Boston
  • Columbia
  • Columbus
  • Fairfax
  • Farmington Hills
  • Houston
  • Lebanon
  • Los Angeles
  • New York
  • Orange
  • Sacramento
  • Seattle
  • St. Louis
  • Tampa
  • Washington
Trial Identifier:

NCT04302025 ML41591

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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, Cobimetinib, Pralsetinib, 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: Stage IB, 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
      • T4 primary NSCLC will be allowed only on the basis of size
      • All patients will undergo clinical staging using CT and PET scanning, as well as brain imaging using MRI. Invasive mediastinal staging by either mediastinoscopy or 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; RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by FDA-approved test
      • 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

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