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

May 17, 2026 updated by: Nuvation Bio Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, MG5 1Z5
        • Recruiting
        • Princess Margaret Cancer Centre-University Health Network
        • Principal Investigator:
          • Geoffrey Liu, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University
        • Contact:
        • Principal Investigator:
          • Owen Scott, MD
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Nan Wu, MD
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Xiang Yan, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510163
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Wenhua Liang, MD
    • Guangxi
      • Nanning, Guangxi, China, 530221
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Naiquan Mao, BS Clin Med
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Haoxian Yang, MD
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Xiangnan Li, MD
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical College Of Hust
        • Contact:
        • Principal Investigator:
          • Qian Chu, MD
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Yongsheng Wang, MD
        • Contact:
      • Nantong, Jiangsu, China, 226300
        • Recruiting
        • Nantong Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Xiaodong Zhang, BS Clin Med
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Principal Investigator:
          • Jun Deng, MD
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'An Jiaotong University
        • Contact:
        • Principal Investigator:
          • Yu Yao, MD
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Pingping Song, MD
      • Linyi, Shandong, China, 276034
        • Recruiting
        • LinYi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jianhua Shi, MS Clin Med
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Lijie Tan, MD
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
        • Principal Investigator:
          • Peng Zhang, MD
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • Caicun Zhou, MD
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
        • Principal Investigator:
          • Qinghua Zhou, MD
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300222
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
        • Principal Investigator:
          • Daqiang Sun, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qixun Chen, BS Clin Med
  • United States
    • California
      • Los Angeles, California, United States, 90404
        • Recruiting
        • UCLA
        • Contact:
        • Principal Investigator:
          • Jonathan Goldman, MD
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhaohui Arter, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Cener (GUMC)
        • Principal Investigator:
          • Stephen Liu, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health
        • Principal Investigator:
          • Mark Socinski, MD
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Health System
        • Contact:
        • Principal Investigator:
          • Andrew Pierson, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Cancer Center
        • Principal Investigator:
          • Mark Sides, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Narjust Florez, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Robert Shen, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Alexander Drilon, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central South
        • Principal Investigator:
          • James Uyeki, MD
        • Contact:
      • Houston, Texas, United States, 45559
        • Recruiting
        • MD Anderson
        • Contact:
        • Principal Investigator:
          • Yasir Elamin, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Alexander Spira, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging.
  2. Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories.

  3. Adequate tissue is available for prospective central laboratory confirmatory testing. Confirmation of central test positivity is required prior to Randomization.

    Note: In the event that the local testing assay is the same as the central testing assay, and the local test was conducted in a CLIA-certified laboratory or local equivalent, prospective central confirmation is not needed, but tumor tissue must still be provided for other biomarker studies.

  4. Age ≥18 years (or ≥20 years as required by local regulations).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Received definitive locoregional curative surgery for stage IB, II, or IIIA NSCLC. All surgical margins of resection must be negative for tumor.
  7. Complete recovery from surgery (including complete wound healing) that was performed ≥4 weeks but no more than 16 weeks before Randomization if no adjuvant chemotherapy was given. Surgery must have occurred ≥4 weeks but no more than 30 weeks prior to Randomization if adjuvant chemotherapy was given. For participants who received post-resection adjuvant chemotherapy, the final dose of chemotherapy must also have occurred at least 7 days before Randomization. All chemotherapy related toxicities must have resolved to baseline or ≤Grade 1 (per CTCAE v5.0) prior to Randomization.

Exclusion Criteria:

  1. Has previously received 1 or more of the following cancer treatments:

    1. Postoperative or planned radiation therapy for the current lung cancer. Note: radiotherapy in the neoadjuvant setting is allowed and must be completed at least 4 weeks prior to Randomization.

    2. Any adjuvant anticancer therapy (including investigational therapy) for treatment of NSCLC other than standard postoperative platinum-based doublet chemotherapy. Participants should have received no more than 4 cycles of the platinum doublet regimen.

      Notes: Adjuvant immune checkpoint inhibitor (ICI) treatment is allowed, but participants should have received no more than 4 cycles of the ICI, and at the time of Randomization, have at least 12 weeks of washout from the last dose of the ICI. Any prior immune-related toxicity, such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.

    3. Neoadjuvant chemotherapy with or without ICIs is allowed. Those treated with prior ICIs are eligible if ≥12 weeks have elapsed after completion of the ICI at the time of Randomization. Any prior immune-related toxicity (if an ICI was given), such as immune-related hepatitis, colitis, or pneumonitis, must be completely resolved prior to Randomization.
    4. Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.
    5. Segmentectomies or wedge resections, instead of complete resections, of the primary tumor. Note: These limited resections are allowed for patients with stage IB disease with T2aN0M0, with tumor size >3 to ≤4 cm, and without visceral pleura or central invasion.
  2. Any investigational therapy for any condition other than NSCLC within 6 months of Randomization.
  3. Co-mutations of epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) fusion.
  4. History of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other tumors curatively treated with no evidence of disease for >3 years after the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
  5. Have clinically significant cardiovascular disease within 3 months prior to Randomization.
  6. Have a known history of uncontrolled hypertension.
  7. Experiencing ongoing cardiac dysrhythmias of ≥Grade 2 (CTCAE v5.0), uncontrolled atrial fibrillation of any CTCAE grade, a QT interval corrected by Fridericia's formula (QTcF) of >470 milliseconds, symptomatic bradycardia <45 bpm; undergoing treatment with medication(s) known to be associated with the development of Torsades de Pointes (TdP).
  8. Have active and clinically significant bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV); or known human immunodeficiency virus (HIV)- or acquired immunodeficiency syndrome-related illness.
  9. Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.
  10. Use of food or drugs that are known as strong cytochrome P450 (CYP)3A inducers or inhibitors within 14 days prior to Randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Taletrectinib Active Arm
Active Arm
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.
Other Names:
  • AB-106
Placebo Comparator: Placebo Arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measure Description: The percentage of participants disease free and alive as determined by investigator assessment at 2, 3, 4, and 5 years after date of randomization.
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).
Measure Description: Defined as the time from the date of randomization until date of death due to any cause.
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).
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence of death (by any cause in the absence of recurrence) by blinded independent central review.
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.
Measure Description: The percent of participants that are alive at 2, 3, 4, and 5 years after date of randomization.
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).
Measure Description: Defined as the time from the date of randomization until the date of disease recurrence within the CNS or death (by any cause in the absence of recurrence) by investigator's assessment and blinded independent central review.
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.
Measure Description: The pharmacokinetics exposure parameters derived from plasma concentrations of taletrectinib.
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).
Measure Description: Defined as the number of patients reporting adverse events within one study arm compared to the overall number of patients within the same study arm.
Time Frame: Up to approximately 5 years after the first patient is randomized (maximum follow-up of 70 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvation Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2025

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

August 30, 2033

Study Registration Dates

First Submitted

August 18, 2025

First Submitted That Met QC Criteria

August 26, 2025

First Posted (Actual)

September 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-106-G319

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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