A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
Trial Status: active
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
Inclusion 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 patients will undergo clinical staging using CT and PET scanning, as well as brain imaging using MRI. Invasive mediastinal staging by either mediastinoscopyor 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 (enrollment closed); RET fusion (enrollment closed), PD-L1, KRAS G12C expression in ≥ 1% tumor cells as determined by FDA-approved test. - 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) DNA test at screening - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV 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 patients 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 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 locations may be listed on ClinicalTrials.gov for NCT04302025.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableLos Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lia Etheridge
Phone: 310-825-7174
Email: LEtheridge@mednet.ucla.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not AvailableColorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Stephanie Biller
Phone: 720-848-0729
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableIllinois
Chicago
Northwestern University
Status: Active
Name Not AvailableMassachusetts
Boston
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not AvailableBrigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not AvailableMinnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Jamie Erin Chaft
Phone: 646-888-4545
Email: chaftj@mskcc.org
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableOhio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase II
Trial Typetreatment
Lead OrganizationGenentech Inc.
- Primary IDML41591
- Secondary IDsNCI-2020-01859
- ClinicalTrials.gov IDNCT04302025