A Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC)
Phase 3
Recruiting
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05170204
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A1: ALK-positive (durvalumab arm) Durvalumab Participants will receive 1500 mg of intravenous (IV) durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first Cohort A1: ALK-Positive (alectinib arm) Alectinib Participants will receive alectinib 600 mg orally twice daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first Cohort A2: ROS 1-positive (entrectinib arm) Entrectinib Participants will receive entrectinib 600 mg orally once daily until completion of treatment period (3 years), or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first. Cohort A2 has been closed to enrollment. Cohort A2: ROS 1-positive (durvalumab arm) Durvalumab Participants will receive 1500 mg of IV durvalumab every 4 weeks until completion of treatment period (1 year) or until disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death, whichever occurs first Cohort A2 has been closed to enrollment.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) From randomization to the first documented disease progression as determined by blinded independent central review (BICR) per Response Evaluation Criterial in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurs first (up to 3 years)
- Secondary Outcome Measures
Name Time Method Time to central nervous system (CNS) progression From randomization to the first occurrence of disease progression in the CNS as determined by BICR per RECIST v1.1 (up to 3 years) Distant metastasis-free survival (DMFS) From randomization to the first occurrence of distant metastasis or death (whichever occurs first) as determined by BICR per RECIST v1.1 (up to 3 years) Objective response rate (ORR), defined as the percentage of participants with measurable disease who attain a complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1 Up to 3 years PFS From randomization to the first documented disease progression as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurs first (up to 3 years) Duration of response (DOR) From the first documented CR or PR to the first documented disease progression or death (whichever occurs first) as determined by the investigator per RECIST v1.1 (up to 3 years) ORR, defined as the percentage of participants with measurable disease who attain a CR or PR as determined by BICR per RECIST v1.1 Up to 3 years DOR From the first documented CR or PR to the first documented disease progression or death (whichever occurs first) as determined by BICR per RECIST v1.1 (up to 3 years) Overall survival (OS) From randomization to death from any cause (up to 5 years) Time to CNS progression From randomization to the first occurrence of disease progression in the CNS as determined by the investigator per RECIST v1.1 (up to 3 years) Time-to-confirmed deterioration (TTCD) From randomization to the first deterioration of >/= 10 points that is either maintained for two consecutive assessments or followed by death from any cause within 3 weeks (up to 3 years) Proportion of participants who have maintained or improved baseline health as measured by the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 physical functioning and role functioning scales 5, 11, and 17 months Proportion of participants who have maintained or improved from their baseline health in cough, chest pain, and dyspnea symptoms as measured using the EORTC QLQ-LC13 5, 11, and 17 months Percentage of participants with adverse events (AEs) Up to 3 years
Trial Locations
- Locations (179)
University of South Alabama
🇺🇸Mobile, Alabama, United States
Southern California Kaiser Permanente
🇺🇸Los Angeles, California, United States
Rocky Mountain Cancer Centers - Lone Tree
🇺🇸Lone Tree, Colorado, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States
Oregon Health Sciences Uni
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tigard, Oregon, United States
Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Scroll for more (169 remaining)University of South Alabama🇺🇸Mobile, Alabama, United States