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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Nuvation Bio Inc.
Study ID
NCT07154706
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Taletrectinib — DRUG
    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.
  • Placebo — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
May 2026
Primary completion
Aug 30, 2030
Completion
Aug 30, 2033

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Taletrectinib Active Arm
    Active Arm
  • Placebo Comparator: Placebo Arm
    Placebo Arm

Primary Outcome Measure

Primary Outcome Measure: To compare the efficacy of taletrectinib with that of placebo, as measured by disease-free survival (DFS) by investigator assessment. [ Time Frame: Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months). ]

Locations (12)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90404
Tina Tieu
[email protected]
310-633-8400
Jonathan Goldman, MD (PRINCIPAL_INVESTIGATOR)
UCI Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Zhaohui Arter, MD
[email protected]
877-827-8839
Zhaohui Arter, MD (PRINCIPAL_INVESTIGATOR)
Georgetown University Medical Cener (GUMC)Washington D.C.District of Columbia20007
Stephen Liu, MD
[email protected]
416-946-4501
Stephen Liu, MD (PRINCIPAL_INVESTIGATOR)
Advent HealthOrlandoFlorida32804
Karin Donaldson
[email protected]
(407) 303-2800
Mark Socinski, MD (PRINCIPAL_INVESTIGATOR)
Saint Alphonsus Health SystemBoiseIdaho83706
Janine Wiese
[email protected]
208-367-7131
Andrew Pierson, MD (PRINCIPAL_INVESTIGATOR)
Tulane Cancer CenterNew OrleansLouisiana70112
Mel Martino
[email protected]
504-988-6120
Mark Sides, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Lindsey Allen
[email protected]
857-215-3105
Narjust Florez, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Karlyn Pierson
[email protected]
(507) 293-0807
Robert Shen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alexander Drilon, MD
[email protected]
646-888-4206
Alexander Drilon, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central SouthAustinTexas78731
Marian Heaven, Manager
[email protected]
512-427-9400
James Uyeki, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas45559
Yasir Elamin, MD
[email protected]
713-792-6363
Yasir Elamin, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Carrie Friedman, Clinical Trials Navigator
[email protected]
703-636-1473
Alexander Spira, MD, PhD (PRINCIPAL_INVESTIGATOR)

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