Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)

PHASE3RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

August 21, 2025

Primary Completion Date

August 30, 2030

Study Completion Date

August 30, 2033

Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
DRUG

Taletrectinib

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.

DRUG

Placebo

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

Trial Locations (3)

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

78731

RECRUITING

Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central South, Austin

02215

RECRUITING

Dana Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nuvation Bio Inc.

INDUSTRY

NCT07154706 - Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) | Biotech Hunter | Biotech Hunter