Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion

Description

Summary

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.

Official Title

NAUTIKA1: Multicenter, Phase II, Neoadjuvant and Adjuvant 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

Keywords

Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Vemurafenib Entrectinib Alectinib Cobimetinib Resection Chemotherapy Pralsetinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology Oncology not yet accepting patients
    Los Angeles California 90095 United States
  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04302025
Phase
Phase 2
Study Type
Interventional
Last Updated