Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT07154368
Eligibility Criteria:
Inclusion Criteria:
* Key Inclusion Criteria
* Subjects with histologically or cytologically documented NSCLC.
* Locally advanced or metastatic ROS1 fusion positive NSCLC.
* Prior one or two ROS1-TKI(s) Treatment.
* World Health Organization (WHO) performance status 0-1.
* Life expectancy of at least 3 months.
* At least one measurable lesion according to RECISIT 1.1.
Exclusion Criteria:
* Key Exclusion Criteria:
* Current participation in another therapeutic clinical trial.
* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
* All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than 1.
* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
* Known active infe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07154368
Study Brief:
Protocol Section:
NCT07154368