🏛️ Verified NIH Record • Updated 2026-08-10

A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) (NCT04302025)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Genentech, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (10 items).

Location: City of Hope Comprehensive Cancer Center — Duarte, California

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria
  • 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
  • Major surgical procedure within 28 days prior to Cycle 1, Day 1
  • Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of participants with a negligible risk of metastasis or death and with expected curative outcome
  • Treatment with an investigational agent for any condition within 4 weeks prior to Cycle 1, Day 1
  • Participants known to be positive for human immunodeficiency virus (HIV) are excluded if they meet any of the following criteria: cluster of differentiation 4 (CD4)+ T-cell count of \<350 cells/microliters (cells/µL); 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • 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
  • UC Davis Comprehensive Cancer Center — Sacramento, California
  • UCSF Helen Diller Family CCC — San Francisco, California
  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) — Aurora, Colorado
  • Yale Cancer Center — New Haven, Connecticut
  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) — Washington D.C., District of Columbia
  • Moffitt Cancer Center — Tampa, Florida
  • Northwestern University — Chicago, Illinois
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois
  • Boston Medical Center — Boston, Massachusetts
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • University of Michigan — Ann Arbor, Michigan
  • Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center — Farmington Hills, Michigan
  • Mayo Clinic — Rochester, Minnesota
  • Ellis Fischel Cancer Center — Columbia, Missouri
  • Siteman Cancer Center - Washington University Medical Campus — St Louis, Missouri
  • Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire
  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone. — New York, New York

📞 Contact the Study Coordinator

Phone: (888) 662-6728

Email: global-roche-genentech-trials@gene.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗