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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT04132102
Eligibility Criteria:
Inclusion Criteria:
* Selected patients must meet all of the following standards:
1. The patient's or his/her legal representative's has signed and dated written informed consent before any specific study procedure.
2. The patient is above 18 years old.
3. Locally advanced (IIIB) or metastatic (stage IV) immunohistochemistry (IHC)-verified Lung squamous cell carcinoma (LSQC) with EGFR sensitive mutation patients, whom previously untreated or received platinum-based doublet chemotherapy as first-line treatment with subsequent disease progression, and had to be eligible for second-line treatment.
4. The patient has NOT previously received EGFR-TKI treatment.
5. ECOG Performance Status Score is 0\~2.
6. The patient has sufficient bone marrow and organ function proved by baseline complete plasma count, plasma biochemistry and urinary biochemistry tests.
7. Female patients of childbearing age must use adequate contraceptives, and breastfeeding is not allowed.
8. Male patients must voluntarily to use contraceptives.
Exclusion criteria
* Selected patients can not meet any one of the following standards:
1. The patient has received EGFR-TKI treatment.
2. The patient has any severe or uncontrolled systemic signs of illness, including uncontrolled hypertension, active easy-bleeding constitution, active infection, or significantly impaired function of bone marrow or organs, which researchers believe can significantly change the patient's risk/benefit balance.
3. The patient has symptomatic central nervous system (CNS) metastases.
4. The patient has the history of interstitial pneumonia, or radiation pneumonia which needs steroid treatment.
5. The patient still has unrecovered toxic reaction with ≥ grade 3 (CTCAE5.0) caused by previously received treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04132102
Study Brief:
Protocol Section:
NCT04132102