NCT04302025 · Genentech, Inc.
A Study of Multiple Therapies in Biomarker-Selected Patients With Resectable Stages IB-III Non-Small Cell Lung Cancer
What this study is about
This trial will evaluate the effectiveness 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
View original scientific description
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
Interventions
DRUG
Alectinib
Participants will receive oral alectinib twice per day (BID).
DRUG
Entrectinib
Participants will receive oral entrectinib daily.
DRUG
Vemurafenib
Participants will receive oral vemurafenib BID.
DRUG
Cobimetinib
Participants will receive oral cobimetinib daily.
DRUG
Pralsetinib
Participants will receive oral pralsetinib daily.
DRUG
Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion.
DRUG
SBRT
Participants will receive SBRT given concurrently, starting with the first dose of atezolizumab.
PROCEDURE
Resection
Participants will receive surgical resection of the primary tumor along with selected lymph nodes per SOC.
DRUG
Chemotherapy
Participants will receive SOC chemotherapy as determined by the treating physician.
DRUG
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.
Primary outcome measures
Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)
Time frame: 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)
Time frame: 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)
Time frame: 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 Investigator
Time frame: After surgical resection (approximately study Week 8)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 evid
Where
- Duarte, California
- Irvine, California
- Los Angeles, California
- Orange, California
- Sacramento, California
- San Francisco, California
- Aurora, Colorado
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Tampa, Florida
- Chicago, Illinois
- DeKalb, Illinois
And 19 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations