A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
NCT04302025 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2026-05-22
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.
Conditions
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
-
Participants will receive oral cobimetinib daily.
- DRUG
-
Pralsetinib
Participants will receive oral pralsetinib daily.
- DRUG
-
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
-
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.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-06
- Primary Completion
- 2026-11-30
- Completion
- 2030-05-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3]
NCT06607393 ·Status: COMPLETED
-
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
NCT01846416 ·Status: COMPLETED ·Phase: PHASE2
-
Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
NCT03600701 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
NCT02047344 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer
NCT05777603 ·Status: RECRUITING ·Phase: PHASE1
-
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
NCT06632327 ·Status: RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)
NCT04924101 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
NCT00686959 ·Status: COMPLETED ·Phase: PHASE3
-
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
NCT04624204 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
NCT06077760 ·Status: RECRUITING ·Phase: PHASE3
-
A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
NCT04832854 ·Status: TERMINATED ·Phase: PHASE2
-
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
NCT05468489 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Neoadjuvant MPDL3280A, Nab-paclitaxel and Carboplatin (MAC) in NSCLC
NCT02716038 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
NCT05920356 ·Status: RECRUITING ·Phase: PHASE3
-
CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS4]
NCT06585189 ·Status: COMPLETED
-
Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)
NCT00312975 ·Status: COMPLETED ·Phase: PHASE2
-
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer
NCT01809210 ·Status: COMPLETED ·Phase: PHASE1
-
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
NCT03737994 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
NCT03846310 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
NCT00040794 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
NCT01519804 ·Status: COMPLETED ·Phase: PHASE2
-
Tocilizumab and Atezolizumab in Adults With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to 1st Line Immune Checkpoint Inhibitor-Based Therapy
NCT04691817 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
NCT01860040 ·Status: TERMINATED ·Phase: PHASE2
-
Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer
NCT07172412 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT04619797 ·Status: COMPLETED ·Phase: PHASE2/PHASE3