A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- 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 Investigator — After surgical resection (approximately study Week 8)
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | Withdrawn |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 |
On this site
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Other trials for the same condition
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