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Study of Multiple Therapies for Resectable Non-small Cell Lung Cancer (NSCLC)

This study is looking at different treatments for people with early-stage, resectable (can be surgically removed) non-small cell lung cancer (NSCLC). You might be eligible if your tumor has specific biomarkers like ALK, BRAF, KRAS, KRAS G12C, PD-L1, RET, or ROS1. The study is testing drugs like alectinib, entrectinib, vemurafenib, cobimetinib, and pralsetinib. Researchers want to see how well these treatments shrink tumors before surgery (measured by major pathologic response or pathological complete response) and if they cause side effects. The study plans to enroll about 99 participants aged 18 and older. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 99 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured after surgical resection, which is approximately study Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04302025

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Genentech, Inc.
~99 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:AlectinibEntrectinibVemurafenibCobimetinibPralsetinibAtezolizumab

At a glance

Recruiting sites
23 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)
Measured over After surgical resection (approximately study Week 8)
+3 more outcomes measured

Conditions

Non-small Cell Lung Cancer

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Lung Non-Small Cell CarcinomaALK GeneBRAF GeneGTPase KRasNTRK Family GeneProgrammed Cell Death 1 Ligand 1ROS1 Gene

NCT04302025

Where you'd take part

This study runs at 38 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Clinical Research Institute

    Memphis, Tennesseeno site contact published

    Recruiting

  • Columbia University Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsno site contact published

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshireno site contact published

    Recruiting

  • Ellis Fischel Cancer Center

    Columbia, Missourino site contact published

    Recruiting

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New Yorkno site contact published

    Recruiting

  • Mayo Clinic

    Rochester, Minnesotano site contact published

    Recruiting

  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

    Washington D.C., District of Columbiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: ML41591 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728
Email the study team

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Eligibility criteria

Inclusion

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
Participants whose tumors lack radiographic progression
ECOG Performance Status of 0 or 1
Adequate hematologic and end-organ function

Exclusion

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

What this trial measures

  • Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)After surgical resection (approximately study Week 8)

    MPR is defined as ≤ 10% residual viable tumor cells as scored by local pathologists.

  • Checkpoint Inhibitor (CPI) Cohort: Pathological Complete Response (pCR)After surgical resection (approximately study Week 8)

    Scored by local pathologists; defined as lack of any viable tumor cells on review of hematoxylin and eosin (H\&E) slides after complete evaluation of a resected lung cancer specimen including all sampled regional lymph nodes.

  • KRAS G12C Cohort: Percentage of Participants With 3-5 Grade Adverse Events (AEs)After surgical resection (approximately study Week 8)
  • KRAS G12C Cohort: Percentage of Participants Without Delays of Surgery due to Treatment-related AEs as Reported by the InvestigatorAfter surgical resection (approximately study Week 8)