September 30, 2025 — Leads & Copy — Nuvation Bio Inc. (NYSE: NUVB) has enrolled the first patient in TRUST-IV (NCT07154706), a Phase 3 study evaluating the efficacy and safety of IBTROZI™ (taletrectinib) versus placebo for the adjuvant treatment of patients with resected ROS1-positive (ROS1+) early-stage non-small cell lung cancer (NSCLC).
The trial, which has aligned with the U.S. Food and Drug Administration on study design, will enroll approximately 180 patients in the U.S., Canada, Europe, Japan, and China with ROS1+ stage IB, II, or IIIA NSCLC who have undergone surgery. Patients must not have received adjuvant anticancer therapy except standard postoperative platinum-based doublet chemotherapy and will be randomized 2:1 to receive either taletrectinib or placebo daily. The primary endpoint is disease-free survival, with an estimated primary completion date in 2033.
Alexander Drilon, M.D., Chief, Early Drug Development, Memorial Sloan Kettering Cancer Center and trial investigator, stated that patients with ROS1 fusion-positive cancers need new options in the adjuvant setting beyond chemotherapy. David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, expressed excitement about exploring IBTROZI’s potential in earlier-stage disease.
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, the FDA approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.
Contact: No contact information was provided in the press release.
Source: Nuvation Bio
