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A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Sponsor: Genentech, Inc.
Summary
This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.
Official title: NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2020-11-06
Completion Date
2030-05-30
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Alectinib
Participants will receive oral alectinib twice per day (BID).
Entrectinib
Participants will receive oral entrectinib daily.
Vemurafenib
Participants will receive oral vemurafenib BID.
Cobimetinib
Participants will receive oral cobimetinib daily.
Pralsetinib
Participants will receive oral pralsetinib daily.
Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion.
SBRT
Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.
Resection
Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.
Chemotherapy
Participants will receive SOC chemotherapy as determined by the treating physician.
Divarasib
Participants in the KRAS G12C cohort will receive oral divarasib for approximately 8 weeks until the day before surgery as neoadjuvant therapy up to 3 years as adjuvant therapy.
Locations (38)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UCSF Helen Diller Family CCC
San Francisco, California, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Kelsey Seybold Clnic
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States