A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT04302025
Last Updated: 2026-01-12
Study Results
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Basic Information
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RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2020-11-06
2030-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ALK Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of alectinib neoadjuvant treatment before undergoing surgical resection per standard of care (SOC). All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with alectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of alectinib.
Enrolment Closed.
Alectinib
Participants will receive oral alectinib twice per day (BID).
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.
ROS 1 Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Enrolment Closed.
Entrectinib
Participants will receive oral entrectinib daily.
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.
NTRK Cohort (Enrolment Closed)
Participants will receive up to 8 weeks of entrectinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with entrectinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of entrectinib.
Enrolment Closed.
Entrectinib
Participants will receive oral entrectinib daily.
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.
BRAF Cohort (No Participants Enrolled, Cohort Closed)
Participants will receive up to 8 weeks of vemurafenib plus cobimetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with vemurafenib plus cobimetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of of vemurafenib plus cobimetinib.
Cohort closed.
Vemurafenib
Participants will receive oral vemurafenib BID.
Cobimetinib
Participants will receive oral cobimetinib daily.
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.
RET Cohort (Cohort closed)
Participants will receive up to 8 weeks of pralsetinib neoadjuvant treatment before undergoing surgical resection per SOC. All participants that undergo surgical resection and whose tumors have pathological response or lack radiographic progression will be eligible for the adjuvant treatment phase with pralsetinib. Adjuvant therapy will consist of 4 cycles of chemotherapy followed by up to 2 years of pralsetinib.
Cohort closed.
Pralsetinib
Participants will receive oral pralsetinib daily.
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.
PD-L1 Cohort (Enrolment Closed)
Participants with positive programmed death-ligand 1 (PD-L1) in ≥1% tumor cells will receive 4 cycles of atezolizumab neoadjuvant treatment. During neoadjuvant Cycle 1 of atezolizumab, participants will also receive low-dose stereotactic body radiation therapy (SBRT) (8 gray \[Gy\] X 3). Adjuvant treatment consists of SOC treatment as determined by the investigator, per National Comprehensive Cancer Network (NCCN) guidelines.
Enrolment Closed.
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.
KRAS G12C Cohort
Participants will receive up to 8 weeks of divarasib as neoadjuvant treatment before undergoing surgical resection per SOC. PD-L1 negative participants whose tumors have pathological response or lack radiographic progression will be have the option of continuing divarasib alone for up to 3 years or 1-4 cycles of SOC chemotherapy followed by divarasib for 3 years as adjuvant therapy. For participants who test positive PD-L1, they will have the option to receive 1-4 cycles of SOC chemotherapy followed by atezolizumab for up to 16 cycles or SOC alone.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Participants whose tumors lack radiographic progression
* ECOG Performance Status of 0 or 1
* Adequate hematologic and end-organ function
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UCSF Helen Diller Family CCC
San Francisco, California, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute - Farmington Hills/Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Ellis Fischel Cancer Center
Columbia, Missouri, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
AHN Cancer Institute ? Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Kelsey Seybold Clnic
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Lumi Research
Kingwood, Texas, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Central Contacts
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Reference Study ID Number: ML41591 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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ML41591
Identifier Type: -
Identifier Source: org_study_id
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