FindTrial
Sign In

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

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521971-29-00
Enrollment
25
Registered
2026-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer (NSCLC)

Brief summary

DFS by Investigator assessment

Detailed description

1 DFS rates by Investigator assessment at 2, 3, 4, and 5 years., 2 Overall survival (OS), 3 DFS by blinded independent central review (BICR)., 4 OS rates at 2, 3, 4, and 5 years., 5 Central nervous system (CNS) DFS by Investigator assessment and by BICR., 6 Plasma concentrations of taletrectinib., 7 Adverse events (AEs), as graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0; laboratory abnormalities as graded by CTCAE v5.0; vital signs, physical examinations, and digital electrocardiograms (ECGs).

Interventions

DRUGTaletrectinib
DRUGPlacebo matching Taletrectinib capsules

Sponsors

Nuvation Bio Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
DFS by Investigator assessment—

Secondary

MeasureTime frame
1 DFS rates by Investigator assessment at 2, 3, 4, and 5 years., 2 Overall survival (OS), 3 DFS by blinded independent central review (BICR)., 4 OS rates at 2, 3, 4, and 5 years., 5 Central nervous system (CNS) DFS by Investigator assessment and by BICR., 6 Plasma concentrations of taletrectinib., 7 Adverse events (AEs), as graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0; laboratory abnormalities as graded by CTCAE v5.0; vital signs, physical examinations, and digital electrocardiograms (ECGs).—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 2, 2026