A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection
Summary
The purpose of this phase 3 multicenter double-blind randomized study is to assess the use of taletrectinib in the early-stage non-small cell lung cancer (NSCLC). The study compares taletrectinib (study drug) versus placebo (sugar pill) in patients with ROS1-fusion positive stage IB, II, IIIA NSCLC. The study will evaluate if taletrectinib is better than placebo at preventing the participant's disease from coming back after the participant's lung tumor was removed.
Arms & interventions
- DrugTaletrectinib
Intervention Label: Taletrectinib Intervention Name: Taletrectinib Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level (s): 400 mg QD Route of Administration: Oral Use: Experimental IMP and NIMP/AxMP : IMP Former Name(s) or Alias(es): AB-106.
- DrugPlacebo
Intervention Label: Placebo Intervention Name: Placebo Type: Drug Dosage Formulation: Capsule Unit Dose Strength(s): 200 mg Dosage Level(s): 400 mg QD Route of Administration: Oral Use: Placebo Comparator IMP and NIMP/AxMP: IMP Former Name(s) or Alias(es): Placebo
Outcome measures
Primary
Primary Outcome Measure: To compare the efficacy of taletrectinib with that of placebo, as measured by disease-free survival (DFS) by investigator assessment.
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence) by investigator's assessment.
Time frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Secondary
Secondary Outcome Measure: DFS rates by investigator assessment at 2, 3, 4, and 5 years.
Time frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months). DFS rate 2 years (%), 3 years (%), 4 years (%), and 5 years (%) are presented.
Secondary Outcome Measure: Overall Survival (OS).
Time frame: Time Frame: Up to approximately 7 years after the first patient is randomized (maximum follow-up of 86 months).
Secondary Outcome Measure: DFS by blinded independent central review (BICR).
Time frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Secondary Outcome Measure: OS rates at 2, 3, 4, and 5 years.
Time frame: Time Frame: Up to approximately 7 years after the first patient is randomized (maximum follow-up of 86 months). DFS rate 2 years (%), 3 years (%), 4 years (%), and 5 years (%) are presented.
Secondary Outcome Measure: Central nervous system (CNS) DFS by Investigator assessment and by BICR.
Time frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Secondary Outcome Measure: Plasma concentrations of taletrectinib.
Time frame: Time Frame: Collected between 1-3 hours post-dose on Cycle1 Day 1, and pre-dose and 1-3 hours post-dose at Cycle 2 Day 1, and pre-dose at Cycle 4 Day 1, and Cycle 7 Day 1. The length of each cycle is 28 days.
Secondary Outcome Measure: Incidence of adverse events (AEs).
Time frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).
Eligibility criteria
Study locations (12)
UCLA
Los Angeles, California, 90404
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
Georgetown University Medical Cener (GUMC)
Washington D.C., District of Columbia, 20007
Advent Health
Orlando, Florida, 32804
Saint Alphonsus Health System
Boise, Idaho, 83706
Tulane Cancer Center
New Orleans, Louisiana, 70112
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central South
Austin, Texas, 78731
MD Anderson
Houston, Texas, 45559
Virginia Cancer Specialists
Fairfax, Virginia, 22031