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

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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…

Interventions

Drug
Alectinib
Participants will receive oral alectinib twice per day (BID).
Drug
Entrectinib
Participants will receive oral entrectinib daily.
Drug
Vemurafenib
Participants will receive oral vemurafenib BID.
Drug
Cobimetinib
Participants will receive oral cobimetinib daily.
Drug
Pralsetinib
Participants will receive oral pralsetinib daily.
Drug
Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion.
Drug
SBRT
Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.
Procedure
Resection
Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.
Drug
Chemotherapy
Participants will receive SOC chemotherapy as determined by the treating physician.
Drug
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
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California
USC Norris Cancer Center
Los Angeles, California
Cedars-Sinai Medical Center
Los Angeles, California
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Los Angeles, California
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

Detailed criteria

Interventions

Drug

Alectinib

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

Drug

Entrectinib

Participants will receive oral entrectinib daily.

Drug

Vemurafenib

Participants will receive oral vemurafenib BID.

Drug

Cobimetinib

Participants will receive oral cobimetinib daily.

Drug

Pralsetinib

Participants will receive oral pralsetinib daily.

Drug

Atezolizumab

Atezolizumab will be administered by intravenous (IV) infusion.

Drug

SBRT

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

Procedure

Resection

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

Drug

Chemotherapy

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

Drug

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
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California
USC Norris Cancer Center
Los Angeles, California
Cedars-Sinai Medical Center
Los Angeles, California
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Los Angeles, California
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California