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

NCT07154706 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-19

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Nuvation Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2030-08-30
Completion
2033-08-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154706 on ClinicalTrials.gov