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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT03861156
Eligibility Criteria:
Inclusion Criteria:
* Aged at least 18 years.
* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
* Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.
* patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-1.
* a minimum life expectancy of 12 weeks.
* At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1.
* Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.
Exclusion Criteria:
* Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.
* Unresolved toxicities from prior therapy.
* Unstable spinal cord compression/brain metastases.
* Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
* QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period.
* Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.
* previous treatment with 2 or more lines of Chemotherapy or immunotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03861156
Study Brief:
Protocol Section:
NCT03861156