Actively Recruiting
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
Led by Nuvation Bio Inc. · Updated on 2026-04-14
180
Participants Needed
29
Research Sites
418 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IB, II, or IIIA NSCLC based on pathological staging
- Documented ROS1 rearrangement in primary tumor by a validated local assay
- Adequate tissue available for central laboratory confirmatory testing
- Age 18 years or older (or 20 years as required by local regulations)
- ECOG performance status of 0 or 1
- Received definitive curative surgery for stage IB, II, or IIIA NSCLC with negative surgical margins
- Complete recovery from surgery, performed 4 to 16 weeks before Randomization if no adjuvant chemotherapy given
- Surgery performed 4 to 30 weeks before Randomization if adjuvant chemotherapy was given
- For those who had chemotherapy, last dose at least 7 days before Randomization and all toxicities resolved to baseline or Grade 1 or less
You will not qualify if you...
- Prior postoperative or planned radiation therapy for current lung cancer (neoadjuvant radiotherapy allowed if completed at least 4 weeks before Randomization)
- Prior adjuvant anticancer therapy for NSCLC other than standard postoperative platinum-based doublet chemotherapy (no more than 4 cycles)
- Prior immune checkpoint inhibitor treatment exceeding 4 cycles or less than 12 weeks washout before Randomization
- Major surgery within 4 weeks of Randomization (excluding vascular access port placement)
- Segmentectomy or wedge resection instead of complete tumor resection except for certain stage IB cases
- Investigational therapy for any condition other than NSCLC within 6 months before Randomization
- Presence of EGFR co-mutations or ALK fusion
- History of other malignancies except specific treated cancers with no evidence of disease for over 3 years
- Significant cardiovascular disease within 3 months before Randomization
- Known uncontrolled hypertension
- Ongoing cardiac dysrhythmias Grade 2 or higher, uncontrolled atrial fibrillation, QTcF over 470 ms, symptomatic bradycardia under 45 bpm, or use of medications linked to Torsades de Pointes
- Active clinically significant infections including hepatitis B, C, HIV/AIDS
- Current or past interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroids
- Use of strong CYP3A inducers or inhibitors within 14 days before Randomization
AI-Screening
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Trial Site Locations
Total: 29 locations
1
UCLA
Los Angeles, California, United States, 90404
Actively Recruiting
2
UCI Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Georgetown University Medical Cener (GUMC)
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
4
Saint Alphonsus Health System
Boise, Idaho, United States, 83706
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central South
Austin, Texas, United States, 78731
Actively Recruiting
9
MD Anderson
Houston, Texas, United States, 45559
Actively Recruiting
10
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
11
Princess Margaret Cancer Centre-University Health Network
Toronto, Ontario, Canada, MG5 1Z5
Actively Recruiting
12
McGill University
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
13
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
14
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
15
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510163
Actively Recruiting
16
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530221
Actively Recruiting
17
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450003
Actively Recruiting
18
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
Actively Recruiting
19
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
20
Nantong Tumor Hospital
Nantong, Jiangsu, China, 226300
Actively Recruiting
21
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
22
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
23
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
24
Linyi Cancer Hospital
Linyi, Shandong, China, 276034
Actively Recruiting
25
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
26
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
27
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
28
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
29
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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