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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT05209256
Eligibility Criteria:
Inclusion Criteria:
* histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;
* an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;
* WHO performance status of 0 or 1;
* no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;
* adequate bone marrow reserve and organ function.
Exclusion Criteria:
* treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;
* symptomatic CNS metastases;
* evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05209256
Study Brief:
Protocol Section:
NCT05209256