A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer (ROSETTA study)(WJOG22925L)

A Multicenter Prospective Observational Study of Taletrectinib in Patients with Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer (ROSETTA study)(WJOG22925L) - ROSETTA study(WJOG22925L)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061120

Enrollment

100

Registered

2026-04-01

Start date

2026-08-12

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Advanced or Recurrent ROS1 Fusion Positive Non Small Cell Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with advanced or recurrent ROS1 fusion positive non small cell lung cancer (NSCLC) that is not amenable to curative treatment. 2. Patients meet one of the following prior treatment criteria: Cohort A: patients who have not previously received treatment with a ROS1 TKI; or Cohort B: patients who have previously received treatment with one or more ROS1 TKI. *There are no restrictions regarding prior treatment with cytotoxic chemotherapy, immune checkpoint inhibitors, or other therapies. 3. Patients who have not previously received taletrectinib and are scheduled to initiate taletrectinib in routine clinical practice in accordance with the latest Japanese package insert. (In principle, treatment with taletrectinib should be initiated after written informed consent has been obtained and patient registration in the electronic data capture (EDC) system has been completed. However, initiation of treatment before EDC registration will be permitted, provided that EDC registration is completed by the next business day after informed consent is obtained.) 4. Patients have undergone radiologic evaluation with CT, including the chest, within 42 days prior to the date of registration, and brain MRI or CT within 56 days prior to the date of registration.Contrast enhanced CT and MRI are preferred; however, non contrast imaging will also be permitted. 5. Patients are aged 18 years or older. 6. Patients have provided written informed consent prior to study registration after receiving a full explanation of the study.

Exclusion criteria

Exclusion criteria: Patients who are deemed unsuitable for participation in this clinical study by the investigator or treating physician.

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Countries

Japan

Contacts

Public ContactNaoki Ishizuka

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results