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Evaluating therapies for early-stage non-small cell lung cancer patients

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

Phase 2 Interventional Genentech, Inc. · NCT04302025

This study is testing different treatments for patients with early-stage non-small cell lung cancer to see which ones work best and are safe.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment99 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations38 sites (Duarte, California and 37 other locations)
Trial IDNCT04302025 on ClinicalTrials.gov

What this trial studies

This trial assesses the effectiveness and safety of multiple therapies in patients diagnosed with resectable stages IB-III non-small cell lung cancer (NSCLC) that meet specific biomarker criteria. Participants will receive treatments such as Alectinib, Entrectinib, and others, while undergoing thorough clinical staging through imaging techniques. The study aims to identify the best therapeutic options for this patient population to improve outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with newly diagnosed, resectable stages IB, IIA, IIB, IIIA, or selected IIIB non-small cell lung cancer.

Not a fit: Patients with advanced or unresectable non-small cell lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide more effective treatment options for patients with early-stage non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise in using biomarker-selected therapies for non-small cell lung cancer, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 a different ipsilateral lobe is not permitted
* All participants will undergo clinical staging using computed tomography (CT) and positron emission tomography (PET) scanning, as well as brain imaging using magnetic resonance imaging (MRI). Invasive mediastinal staging by either mediastinoscopyor endo- bronchial ultrasonography is highly encouraged for participants 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 clinical laboratory improvement amendments (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, KRAS G12C mutation
* Measurable disease, as defined by RECIST v1.1
* NSCLC must have a solid or subsolid appearance on CT scan and cannot have a purely ground glass opacity appearance. For subsolid lesions, the tumor size (i.e., clinical T stage) should be measured based on the solid component only, exclusive of the ground glass opacity component
* 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
* Adequate hematologic and end-organ function
* Negative hepatitis B surface antigen (HBsAg) test at screening for cohort
* Negative total hepatitits B core antibody (HBcAb) test at screening for cohort, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test at screening
* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
* 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 (TKI Cohorts and KRAS G12C cohort \[if continuing on Divarasib\]):

* 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
* 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

Where this trial is running

Duarte, California and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.