Taletrectinib

DRUG10 trials

Conditions

Breast CancerBronchogenic CarcinomaCarcinomaHealthy Adult ParticipantsLung DiseasesLung NeoplasmsMetastatic Breast CancerNeoplasms

Phase 1

Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

Not yet recruitingNCT07742384

Nuvation Bio Inc.Healthy Adult Participants

Start: 2026-08-01End: 2027-02-02Target: 56Updated: 2026-08-03

Phase 2

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Active, not recruitingNCT04919811

Nuvation Bio Inc.Non Small Cell Lung Cancer

Start: 2021-09-01End: 2027-12-31Updated: 2026-01-07

Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)

SuspendedNCT06214793

Megan Kruse, MDBreast Cancer, Metastatic Breast Cancer

Start: 2026-10-01End: 2030-01-01Target: 61Updated: 2026-06-05

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors

Active, not recruitingCTIS2024-516604-41-00

Anheart Therapeutics Inc.Non-small Cell Lung Cancer

Start: 2022-08-08Target: 98Updated: 2025-11-13

Phase 3

A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients

RecruitingNCT06564324

Nuvation Bio Inc.Non Small Cell Lung Cancer

Start: 2024-11-27End: 2030-09-01Target: 194Updated: 2026-04-13

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

RecruitingNCT07154706

Nuvation Bio Inc.Non-small Cell Lung Cancer (NSCLC)

Start: 2025-08-21End: 2033-08-30Target: 180Updated: 2026-05-19

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

Not yet recruitingCTIS2025-521971-29-00

Nuvation Bio Inc.Non Small Cell Lung Cancer (NSCLC)

Target: 25Updated: 2026-07-01

Unknown Phase

Expanded Access Program of Taletrectinib in Patients With Advanced or Metastatic ROS1-Positive NSCLC

NCT06841874

Nuvation Bio Inc.Bronchogenic Carcinoma, Carcinoma, Lung Diseases +8

Updated: 2025-12-24

Real-world Study of Taletrectinib for Advanced ROS1+ NSCLC With Brain Metastases

RecruitingNCT07008287

Innovent Biologics (Suzhou) Co. Ltd.Non-Small Cell Lung Cancer

Start: 2025-06-04End: 2027-12-31Target: 100Updated: 2025-07-22

Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

Not yet recruitingNCT07199010

Innovent Biologics (Suzhou) Co. Ltd.Non-small Lung Cancer

Start: 2025-10-31End: 2027-12-31Target: 50Updated: 2025-09-30

Journal of Clinical Oncology2026-05-28

Randomized, double-blind, phase 3 TRUST-IV study of adjuvant taletrectinib vs placebo in patients with stage IB–IIIA ROS1+ non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2026-05-28

Abstract CT244: Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II

Cancer Research2026-04-17

Abstract CT300: Taletrectinib in tyrosine kinase inhibitor (TKI)-naïve patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II

Cancer Research2026-04-17

Comparable efficacy and safety of taletrectinib for advanced ROS1+ non–small cell lung cancer across pivotal studies and between races and world regions.

Journal of Clinical Oncology2025-05-281 citations

Abstract 5612: Taletrectinib, a next generation selective ROS1 inhibitor, inhibits growth of ROS1 wild-type and ROS1-G2032R xenografts

Cancer Research2025-04-211 citations

Efficacy and Safety of Taletrectinib in Chinese Patients With <i>ROS1+</i> Non–Small Cell Lung Cancer: The Phase II TRUST-I Study

Journal of Clinical Oncology2024-06-0128 citations

Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study.

Journal of Clinical Oncology2024-06-01

TRUST-II: A global phase II study for taletrectinib in <i>ROS1</i> fusion–positive lung cancer and other solid tumors.

Journal of Clinical Oncology2022-06-014 citations