NAUTIKA1: Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer

What's the purpose of this trial?

This trial will evaluate the efficacy and safety of various therapies in patients with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated non-small cell lung cancer (NSCLC) tumors that meet protocol-specified biomarker criteria

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria for Neoadjuvant Therapy:

* Pathologically documented NSCLC: Stage IB, IIA, IIB, IIIA, or selected IIIB, including T3N2, or T4 (by size criteria, not by mediastinal invasion) NSCLC (based on the 8th edition of the American Joint Committee on Cancer \[AJCC\] Non-Small Cell Lung Cancer Staging system
* T4 primary NSCLC will be allowed only on the basis of size
* All patients will undergo clinical staging using CT and PET scanning, as well as brain imaging using MRI. Invasive mediastinal staging by either mediastinoscopy or endo- bronchial ultrasonography is highly encouraged for patients with radiographically suspected mediastinal nodal disease (ie, N2) but not mandated if the CT or PET scans showed no evidence of N2 disease.
* Molecular testing results from CLIA-certified laboratories and showing at least one of the following abnormalities: ALK fusion, ROS1 fusion, NTRK1/2/3 fusion; BRAF V600 mutation; RET fusion, PD-L1 expression in ≥ 1% tumor cells as determined by FDA-approved test
* Measurable disease, as defined by RECIST v1.1
* Evaluated by the attending surgeon prior to study enrollment to verify that the primary tumor and any involved lymph nodes are technically completely resectable and verify that the participant is medically operable
* Adequate pulmonary function to be eligible for surgical resection with curative intent
* Adequate cardiac function to be eligible for surgical resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Male participants must be willing to use acceptable methods of contraception
* Female participants of childbearing potential must agree to use acceptable methods of contraception

Inclusion Criteria for Adjuvant Therapy

* Participants whose tumors lack radiographic progression
* ECOG Performance Status of 0 or 1
* Adequate hematologic and end-organ function

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 that have been in remission for \<2 years with the exception of minimally invasive adenocarcinoma or incidental typical carcinoid tumors
* Major surgical procedure within 28 days prior to Cycle 1, Day 1
* Participants known to be positive for HIV are excluded if they meet any of the following criteria: CD4+ T-cell count of \<350 cells/microliters; 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

Additional Trial Information

Phase 2

Enrollment: 85 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.


UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

USC Norris Comprehensive Cancer Center University of Southern California

Los Angeles, CA

Open and Accepting

Providence St. Joseph Hospital Orange

Orange, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting


University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting


Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting


Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting


University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting


Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Ellis Fischel Cancer Center University of Missouri Health

Columbia, MO

Open and Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Perlmutter Cancer Center at NYU Langone Arena Oncology

North New Hyde Park, NY

Open and Accepting



MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting


Virginia Cancer Specialists

Fairfax, VA

Open and Accepting


Seattle Cancer Care Alliance SCCA

Seattle, WA

Open and Accepting

Washington, D.C.

MedStar Georgetown University Hospital

Washington, DC

Open and Accepting
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