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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04814056
Eligibility Criteria:
Inclusion Criteria:
* The patient or his/her legal representative has signed a written informed consent form and dated it prior to any specific research procedure.
* Aged 18 years or older.
* Locally advanced or metastatic non-small cell lung cancer with NRG1 fusion detected by DNA or RNA-based next-generation sequencing (NGS) technology in tumor tissue specimens or liquid specimens.
* The patient has received platinum-based doublet chemotherapy previously.
* ECOG performance status score is 0\~2.
* The patient has sufficient bone marrow and organ functionality, which can be proved by complete blood cell count, blood biochemistry and urine biochemistry tests at baseline.
* The patient has measurable lesion(s).
* The female patient of childbearing age must adopt appropriate contraceptive measures and are not allowed to breastfeed a child.
* The male patient must voluntarily use contraceptives.
Exclusion Criteria:
* The patient has shown any severe or uncontrollable systemic disease sign that the investigators believe may significantly change the risk/benefit balance of the patient, including uncontrollable hypertension, high active bleeding tendency, active infection or significant damage of bone marrow or other functions.
* The patient has previously been treated with EGFR-TKI or any monoclonal antibody that acts on HER2/3.
* The patient has been found with symptomatic metastatic tumor of central nervous system (CNS).
* The patient has a history of interstitial pneumonia or radiation pneumonia requiring steroid therapy.
* The patient has not recovered yet from toxic reactions with CTCAE grade ≥3 (CTCAE5.0) caused by previous treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04814056
Study Brief:
Protocol Section:
NCT04814056