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
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
- DrugAlectinib
Participants will receive oral alectinib twice per day (BID).
- DrugEntrectinib
Participants will receive oral entrectinib daily.
- DrugVemurafenib
Participants will receive oral vemurafenib BID.
- DrugCobimetinib
Participants will receive oral cobimetinib daily.
- DrugPralsetinib
Participants will receive oral pralsetinib daily.
- DrugAtezolizumab
Atezolizumab will be administered by intravenous (IV) infusion.
- DrugSBRT
Locations (38)
- City of Hope Comprehensive Cancer CenterDuarte, California
- City of Hope - Orange County Lennar Foundation Cancer CenterIrvine, California
- USC Norris Cancer CenterLos Angeles, California
- Cedars-Sinai Medical CenterLos Angeles, California
- University of California Los Angeles - Jonsson Comprehensive Cancer CenterLos Angeles, California
- The Center for Cancer Prevention and Treatment at St.Joseph Hospital of OrangeOrange, California