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Non-small Cell Lung Cancer (NSCLC)Phase 3NCT07154706

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

A Phase 3 study testing Taletrectinib in people with Non-small Cell Lung Cancer (NSCLC), run by Nuvation Bio Inc. at 33 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Taletrectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
33 sitesin 3 countries
Study dates
21 Aug 2025to 30 Aug 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed stage IB, II, or IIIA NSCLC (AJCC 9th edition) based on pathological staging.
  • Documented ROS1 rearrangement in primary tumor by a validated local assay performed in CLIA-certified or locally equivalent diagnostic laboratories.
  • 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.
  • Age ≥18 years (or ≥20 years as required by local regulations).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Received definitive locoregional curative surgery for stage IB, II, or IIIA NSCLC. All surgical margins of resection must be negative for tumor.
  • 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.

Who cannot join

  • Has previously received 1 or more of the following cancer treatments:
  • 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.
  • 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.
  • 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.
  • Major surgery (including surgical resection of the primary tumor but excluding placement of vascular access port) within 4 weeks of Randomization.
Show all 16Show fewer
  • 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.
  • Any investigational therapy for any condition other than NSCLC within 6 months of Randomization.
  • Co-mutations of epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) fusion.
  • 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.
  • Have clinically significant cardiovascular disease within 3 months prior to Randomization.
  • Have a known history of uncontrolled hypertension.
  • 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).
  • 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.
  • Currently have or have a history of interstitial lung disease (ILD), drug-related pneumonitis, or radiation pneumonitis that required steroid treatment.
  • Use of food or drugs that are known as strong cytochrome P450 (CYP)3A inducers or inhibitors within 14 days prior to Randomization.

Trial locations and contacts

33 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

33 sites in 3 countries

China19 sites, 19 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Xiang Yan, MD, 13581786750, yanxiang@pkuph.edu.cn

    Xiang Yan, MD

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Nan Wu, MD, 13940154426, nanwu@bjmu.edu.cn

    Nan Wu, MD

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Qinghua Zhou, MD, 18980606202, Prof._QH.Zhou_GCP@wchscu.cn

    Qinghua Zhou, MD

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163

    Wenhua Liang, MD, 13710249454, liangwh@gird.cn

    Wenhua Liang, MD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangzhou, 510060

    Haoxian Yang, MD, 13610052912, yanghx@sysucc.org.cn

    Haoxian Yang, MD

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Qixun Chen, BS Clin Med, 13958108371, chenqixun64@163.com

    Qixun Chen, BS Clin Med

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong, 250117

    Pingping Song, MD, 18663776711, spp128@126.com

    Pingping Song, MD

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong, 276034

    Jianhua Shi, MS Clin Med, 15963998868, shijianhualy@126.com

    Jianhua Shi, MS Clin Med

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Jun Deng, MD, 15079140883, dengjun19871106@ncu.edu.cn

    Jun Deng, MD

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Yongsheng Wang, MD, 15150580136, 15150580136@163.com

    Yongsheng Wang, MD

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530221

    Naiquan Mao, BS Clin Med, 13978889618, maonaiquan@126.com

    Naiquan Mao, BS Clin Med

    Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226300

    Xiaodong Zhang, BS Clin Med, 15051243672, 419317110@qq.com

    Xiaodong Zhang, BS Clin Med

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Lijie Tan, MD, 13681972151, tan.lijie@zs-hospital.sh.cn

    Lijie Tan, MD

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Caicun Zhou, MD, 13301825532, caicunzhoudr@163.com

    Caicun Zhou, MD

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Peng Zhang, MD, 13512185932, zhangpeng1121@tongji.edu.cn

    Peng Zhang, MD

    Recruiting

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

    Daqiang Sun, MD, 13034337758, sdqmd@tju.edu.cn

    Daqiang Sun, MD

    Recruiting

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, 430030

    Qian Chu, MD, 13212760751, qchu@hust.edu.cn

    Qian Chu, MD

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Yu Yao, MD, 13572101611, 13572101611@163.com

    Yu Yao, MD

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450003

    Xiangnan Li, MD, 13592502553, lxn_2000@163.com

    Xiangnan Li, MD

    Recruiting

Other trials in China

United States12 sites, 12 recruiting

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

    Austin, Texas, 78731

    Marian Heaven, Manager, 512-427-9400, marian.heaven@usoncology.com

    James Uyeki, MD

    Recruiting

  • Saint Alphonsus Health System

    Boise, Idaho, 83706

    Janine Wiese, 208-367-7131, Janine.Wiese@SaintAlphonsus.org

    Andrew Pierson, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Lindsey Allen, 857-215-3105, Lindsey_allen@dfci.harvard.edu

    Narjust Florez, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Carrie Friedman, Clinical Trials Navigator, 703-636-1473, carrie.friedman@usoncology.com

    Alexander Spira, MD, PhD

    Recruiting

  • MD Anderson

    Houston, Texas, 45559

    Yasir Elamin, MD, 713-792-6363, yyelamin@mdanderson.org

    Yasir Elamin, MD

    Recruiting

  • UCLA

    Los Angeles, California, 90404

    Tina Tieu, 310-633-8400, TinaTieu@mednet.ucla.edu

    Jonathan Goldman, MD

    Recruiting

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

    Mel Martino, 504-988-6120, mmartino1@tulane.edu

    Mark Sides, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Alexander Drilon, MD, 646-888-4206, drilona@mskcc.org

    Alexander Drilon, MD

    Recruiting

  • UCI Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Zhaohui Arter, MD, 877-827-8839, ucstudy@hs.uci.edu

    Zhaohui Arter, MD

    Recruiting

  • Advent Health

    Orlando, Florida, 32804

    Karin Donaldson, (407) 303-2800 ext. 1114439, Karin.Donaldson@AdventHealth.com

    Mark Socinski, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Karlyn Pierson, (507) 293-0807, RSTTHORACICRES@mayo.edu

    Robert Shen, MD

    Recruiting

  • Georgetown University Medical Cener (GUMC)

    Washington D.C., District of Columbia, 20007

    Stephen Liu, MD, 416-946-4501 ext. 3428, stephen.v.liu@gunet.georgetown.edu

    Stephen Liu, MD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • McGill University

    Montreal, Quebec, H4A 3J1

    Scott Owen, MD, 514-934-1934, scott.owen.med@ssss.gouv.qc.ca

    Owen Scott, MD

    Recruiting

  • Princess Margaret Cancer Centre-University Health Network

    Toronto, Ontario, MG5 1Z5

    Geoffrey Liu, MD, 416-946-4501 ext. 3428, geoffrey.liu@uhn.ca

    Geoffrey Liu, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Being tested
Taletrectinib, Placebo
Keywords
NSCLC, Adjuvant, ROS1, Stage IB, Stage II, Stage IIIA, Resection
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TaletrectinibDrug

    Also called AB-106

    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.

  • PlaceboDrug

    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 groups in NCT07154706
Study groupRoleWhat they receive
Taletrectinib Active ArmActive comparatorActive Arm
Receives: Drug: Taletrectinib
Placebo ArmPlacebo comparatorPlacebo Arm
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (7)

  1. Secondary Outcome Measure: DFS rates by investigator assessment at 2, 3, 4, and 5 years.

    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.

    Measured: 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.

  2. Secondary Outcome Measure: Overall Survival (OS).

    Measure Description: Defined as the time from the date of randomization until date of death due to any cause.

    Measured: Time Frame: Up to approximately 7 years after the first patient is randomized (maximum follow-up of 86 months).

  3. Secondary Outcome Measure: DFS by blinded independent central review (BICR).

    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.

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

  4. Secondary Outcome Measure: OS rates at 2, 3, 4, and 5 years.

    Measure Description: The percent of participants that are alive at 2, 3, 4, and 5 years after date of randomization.

    Measured: 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.

  5. Secondary Outcome Measure: Central nervous system (CNS) DFS by Investigator assessment and by BICR.

    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.

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

  6. Secondary Outcome Measure: Plasma concentrations of taletrectinib.

    Measure Description: The pharmacokinetics exposure parameters derived from plasma concentrations of taletrectinib.

    Measured: 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.

  7. Secondary Outcome Measure: Incidence of adverse events (AEs).

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start21 Aug 2025
  3. Primary completion30 Aug 2030 (estimated)
  4. Study completion30 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154706
Sponsor's protocol ID
AB-106-G319
Status last verified
May 2026
First submitted
18 Aug 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Taletrectinib in people with Non-small Cell Lung Cancer (NSCLC), run by Nuvation Bio Inc. at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07154706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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