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Clinical Trials in the USA / NCT04302025
Recruiting Phase 2

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

NCT04302025 · tracked via the Priya Life Science USA tracker
Sponsor
Genentech, Inc.
Phase
Phase 2
Started
2020-11-06
Last updated
2026-09-10

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

AlectinibEntrectinibVemurafenibCobimetinibPralsetinibAtezolizumabSBRTResectionChemotherapyDivarasib

Alectinib: Participants will receive oral alectinib twice per day (BID).

Entrectinib: Participants will receive oral entrectinib daily.

Vemurafenib: Participants will receive oral vemurafenib BID.

Cobimetinib: Participants will receive oral cobimetinib daily.

Pralsetinib: Participants will receive oral pralsetinib daily.

Atezolizumab: Atezolizumab will be administered by intravenous (IV) infusion.

SBRT: Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.

Resection: Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.

Chemotherapy: Participants will receive SOC chemotherapy as determined by the treating physician.

Divarasib: Participants in the KRAS G12C cohort will receive oral divarasib for approximately 8 weeks until the day before surgery as neoadjuvant therapy up to 3 years as adjuvant therapy.

Study 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

Sex
ALL
Min age
18 Years
Max age
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 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 mediastinoscopy or endo-bronchial ultrasonography is highly encouraged for participants with radiographically suspected mediastinal nodal disease (i.e., 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 Food and Drug Administration (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

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
City of Hope Comprehensive Cancer Center Duarte California Withdrawn
City of Hope - Orange County Lennar Foundation Cancer Center Irvine California Withdrawn
USC Norris Cancer Center Los Angeles California Withdrawn
Cedars-Sinai Medical Center Los Angeles California Withdrawn
University of California Los Angeles - Jonsson Comprehensive Cancer Center Los Angeles California Recruiting
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange Orange California Recruiting
UC Davis Comprehensive Cancer Center Sacramento California Recruiting
UCSF Helen Diller Family CCC San Francisco California Withdrawn
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) Aurora Colorado Withdrawn
Yale Cancer Center New Haven Connecticut Recruiting
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) Washington D.C. District of Columbia Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Northwestern University Chicago Illinois Recruiting
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois Recruiting
Northwestern Medicine Cancer Center Delnor Geneva Illinois Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois Recruiting
Boston Medical Center Boston Massachusetts Withdrawn
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center Farmington Hills Michigan Withdrawn
Mayo Clinic Rochester Minnesota Recruiting
Ellis Fischel Cancer Center Columbia Missouri Recruiting
Siteman Cancer Center - Washington University Medical Campus St Louis Missouri Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Laura and ISAAC Perlmutter Cancer Center at NYU Langone. New York New York Recruiting
Columbia University Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Withdrawn
Ohio State University Columbus Ohio Recruiting
AHN Cancer Institute ? Allegheny General Hospital Pittsburgh Pennsylvania Completed
Baptist Clinical Research Institute Memphis Tennessee Recruiting
Tennessee Oncology - Nashville Nashville Tennessee Withdrawn
Kelsey Seybold Clnic Houston Texas Withdrawn
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Baylor College of Medicine Houston Texas Withdrawn
Lumi Research Kingwood Texas Withdrawn
Virginia Cancer Specialists (Fairfax) - USOR Fairfax Virginia Recruiting
Seattle Cancer Care Alliance Seattle Washington Withdrawn

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04302025 on ClinicalTrials.gov ↗ ← All trials in the USA