NCT04302025

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-06
• Primary completion: 2026-11-30
• Completion: 2030-05-30
• First posted: 2020-03-10
• Last updated: 2026-04-03

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study