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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer (NSCLC)

In brief

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 facts

Study ID

NCT07154706

Run by

Nuvation Bio Inc.

People needed

180

Starts

2025-08-21

Expected to finish

2033-08-30

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• UCLA — Los Angeles, California, United States (enrolling)
• UCI Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• Georgetown University Medical Cener (GUMC) — Washington D.C., District of Columbia, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Saint Alphonsus Health System — Boise, Idaho, United States (enrolling)
• Tulane Cancer Center — New Orleans, Louisiana, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Sarah Cannon Research Institute (SCRI) - Texas Oncology-Central South — Austin, Texas, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Princess Margaret Cancer Centre-University Health Network — Toronto, Ontario, Canada (enrolling)
• McGill University — Montreal, Quebec, Canada (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangzhou, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.