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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05351320
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 years or older;
* Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
* Has active mutation of ALK or ROS1;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Has at least one evaluable lesion (according to RECIST 1.1);
* Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) \>50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) \>40% of predicted normal value;
* Have adequate organ and marrow function;
* If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
* A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.
Exclusion Criteria:
* Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
* Mixed small cell and non-small cell lung cancer histology;
* Has received prior therapy with any ALK TKI;
* Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.
Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;
* History of primary immunodeficiency;
* Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05351320
Study Brief:
Protocol Section:
NCT05351320