First Patient Enrolled in Global Phase 3 Study Aimed at Post-Surgical NSCLC Patients
Nuvation Bio (NYSE: NUVB) marked a significant milestone today, announcing enrollment of the first patient in its pivotal TRUST-IV Phase 3 study of IBTROZI (taletrectinib). The trial is focused on early-stage non-small cell lung cancer (NSCLC) patients who harbor ROS1-positive tumors—representing a patient population with historically limited adjuvant treatment options beyond chemotherapy.
Key Study Details Highlight Expanding Role for Targeted Therapies
TRUST-IV is set to enroll approximately 180 patients across the U.S., Canada, Europe, Japan, and China, randomizing participants 2:1 between IBTROZI and placebo following surgical resection and standard chemotherapy. The study’s primary endpoint is disease-free survival, an essential measure for reducing post-surgery cancer recurrence in this population. Primary results are anticipated by 2033.
| Study Name | Target Population | Geography | Primary Endpoint | Sample Size | Estimated Completion |
|---|---|---|---|---|---|
| TRUST-IV (NCT07154706) | Early-stage, ROS1+ NSCLC, post-resection | U.S., Canada, Europe, Japan, China | Disease-Free Survival | 180 | 2033 |
Recent FDA Approval Adds Weight to the Trial's Rationale
The study’s launch follows the recent FDA approval of IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC, positioning it as one of the few targeted options in a challenging setting. With approximately 2% of the more than one million new annual NSCLC cases being ROS1-positive, and about 20–30% of these amenable to surgical resection, the patient impact could be substantial.
Safety and Adverse Event Profile in Focus
While IBTROZI’s next-generation, CNS-active ROS1 inhibition mechanism holds promise for efficacy, the therapy does come with notable safety considerations. The most common adverse reactions reported (in =20% of patients) include diarrhea, nausea, vomiting, dizziness, rash, constipation, and fatigue. More serious risks such as hepatotoxicity, interstitial lung disease (2.3% of patients), QTc interval prolongation (13% had >60 ms QTcF increase), hyperuricemia (14%), and skeletal fractures (3.4%) are important for both clinicians and patients to monitor.
| Adverse Event | Incidence (%) | Grade 3/4 (%) |
|---|---|---|
| Diarrhea | 64 | - |
| Nausea | 47 | - |
| Vomiting | 43 | - |
| Rash | 22 | - |
| Increased ALT | 85 | 13 |
| Increased AST | 88 | 10 |
| Skeletal Fractures | 3.4 | 1.4 |
| QTcF Prolongation (>60 ms) | 13 | 3.4 |
| ILD/Pneumonitis | 2.3 | 1.1 |
Takeaway: New Hope Emerges for Early-Stage ROS1+ NSCLC Patients
For early-stage NSCLC patients facing the risk of recurrence post-surgery, IBTROZI’s expanded study could signal a paradigm shift—provided results support its efficacy and safety. Nuvation Bio’s continued pipeline momentum is likely to remain in focus as the trial progresses and results become available.
For those following developments in targeted lung cancer treatments, the TRUST-IV study marks a key event worth watching closely over the coming years.
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