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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05496166
Eligibility Criteria:
Inclusion Criteria:
* after signing informed consent;
* Aged 18-70;
* Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
* For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
* Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy
* ECOG performance status score 0-1 points;
* With a life expectancy of at least 12 weeks;
* At least one measurable tumor
* With normal Other major organs (liver, kidney, blood system, etc.) function:
Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90 g/L. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;
\- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \<3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases
* Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;
* Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.
Exclusion Criteria:
* Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
* Patients with other malignancies within five years prior to the start of the trial;
* Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;
* With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;
* Allergy to the test drug;
* Have or currently have interstitial lung disease;
* Coexisting with HIV infection or active hepatitis;
* Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;
* Pregnant or breastfeeding women;
* Those who suffer from neurological diseases or mental illnesses who cannot cooperate;
* Other reasons that investigators deem inappropriate for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05496166
Study Brief:
Protocol Section:
NCT05496166