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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT04055792
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the following criteria to be enrolled:
* Histologically or cytologically confirmed ED-SCLC according to the VALG staging system, and not suitable for local treatment.
* Progressed after at least one line of platinum-containing chemotherapy.
* ≥1 measurable lesions based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).
* Previous radiotherapy was allowed, but the radiotherapy area must be \<25% of the bone marrow area (Cristy and Eckerman 1987) and no total pelvic or chest irradiation was used; the previous radiotherapy must have been completed for at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored; radiotherapy of local lesions cannot be included in measurable lesions unless significant progression is noted after radiotherapy.
* Prior surgery was allowed, provided that the treatment was completed at least 4 weeks before the start of study drugs treatment, and the acute toxicity must have been restored.
* ≥18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
* Life expectancy \> 12 weeks.
* Adequate bone marrow, hepatic and renal function.
* Systolic blood pressure ≤160mmHg and diastolic pressure ≤90mmHg within 7 days before enrollment.
* Patients must sign study specific informed consent before registration.
* Female patients should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactating; Male patients should be surgically sterilized or who have consented to use a medically approved form of contraception during the study treatment period and for 6 months after the end of the study treatment period.
Exclusion Criteria:
Any of the following conditions should not be included in this study:
* Patients with brain metastasis. Patients suspected of having brain metastases should be examined by brain CT or MRI before enrollment; Patients with a history of brain metastases must have completed treatment and no longer need corticosteroids; For asymptomatic patients, the investigator will determine whether to enroll.
* Patients with meningeal metastasis.
* Prior treatment with PD-1 inhibitor, PD-L1 inhibitor, CTLA4 inhibitor, or anti-angiogenic treatment.
* Accept any other anti-tumor treatment simultaneously.
* Diagnosed with active autoimmune diseases (congenital or acquired, patients with completely relieved or childhood vitiligo can be enrolled; patients with hypothyroidism and only need hormone replacement therapy can be rerolled; Patients with type 1 diabetes can also be enrolled).
* Diagnosed with interstitial pneumonia.
* Patients with hemorrhage tendency including acute hemorrhage of digestive tract, continuous hemorrhage disease or coagulation function disorder disease.
* Patients are using warfarin, heparin or aspirin (\>325 mg/day) or NSAIDS to inhibit platelet function within 10 days prior to enrollment, or receiving dipyridamole, ticlopidine, clopidogrel or cilostazol treatment.
* Patients with accompanying diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
* Pregnant or lactating female.
* Prior other malignant diseases, except for cervical carcinoma in situ, papillary thyroid carcinoma, or non-melanoma skin cancer.
* Allergy to any component of the study drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04055792
Study Brief:
Protocol Section:
NCT04055792