RecruitingPhase 2NCT04302025

A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)

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

Sponsor

Genentech, Inc.

Enrollment

99 participants

Start Date

Nov 6, 2020

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing several different drug combinations given before surgery (neoadjuvant therapy) to treat early-stage non-small cell lung cancer (NSCLC), to see which combinations work best based on specific genetic features (biomarkers) in a patient's tumor. **You may be eligible if...** - You have a newly diagnosed early-stage NSCLC (stage IB through IIIB, T3N2 only) - Your cancer has not yet been treated with surgery, chemotherapy, or other drugs - Your cancer can be surgically removed - You have had appropriate staging scans (CT, PET, and brain imaging) - You are in adequate overall health **You may NOT be eligible if...** - You have already received treatment for this lung cancer - Your cancer has spread outside the chest or to both sides of the chest - You have active autoimmune disease - You have serious heart, liver, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

Participants will receive oral alectinib twice per day (BID).

DRUGEntrectinib

Participants will receive oral entrectinib daily.

DRUGVemurafenib

Participants will receive oral vemurafenib BID.

DRUGCobimetinib

Participants will receive oral cobimetinib daily.

DRUGPralsetinib

Participants will receive oral pralsetinib daily.

DRUGAtezolizumab

Atezolizumab will be administered by intravenous (IV) infusion.

DRUGSBRT

Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.

PROCEDUREResection

Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.

DRUGChemotherapy

Participants will receive SOC chemotherapy as determined by the treating physician.

DRUGDivarasib

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

View Full Details on ClinicalTrials.gov

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NCT04302025

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