Clinical trial

Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance

Name
2021YJZ97
Description
To validate the predictive value of transcriptome-based molecular subtyping of extensive stage small cell lung cancer (SCLC) for the efficacy of programmed death-1(PD-1)/programmed death-ligand1(PD-L1) inhibitor in the first line setting; to explore the differences of immune microenvironment between different SCLC subtypes to reveal the mechanisms of immunotherapy resistance of SCLC
Trial arms
Trial start
2022-03-29
Estimated PCD
2024-06-01
Trial end
2024-12-31
Status
Recruiting
Treatment
PD-(L)1 antibody immunotherapy
The treatment regimen involved in this study follows guidelines for the first-line treatment of extensive stage SCLC: cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitor.
Arms:
immunotherapy cohort
Size
200
Primary endpoint
Progression-free survival
2022.4.1-2023.12.31
Eligibility criteria
Inclusion Criteria: * The enrolled subjects shall meet all the following conditions at the same time. 1. Male or female, aged 18 to 100 years 2. Patients with untreated advanced small cell lung cancer clearly diagnosed by histopathology 3. Be able to provide tumor biopsy tissue sample for molecular analysis 4. Eastern Cooperative oncology Group (ECOG) score: 0\~2 5. Expected survival of more than 3 months. 6. Has at least 1 measurable or evaluable tumor lesion with a longest diameter ≥ 10 mm at baseline (in case of lymph nodes, a shortest diameter ≥ 15 mm is required) according to RECIST v1.1 7. Received first-line chemotherapy or chemotherapy+PD-(L)1 inhibitor and be able to provide complete treatment information and efficacy evaluation results. 8. Voluntary signed informed consent and expected good compliance. Exclusion Criteria: * Those meeting any of the following conditions may not be included. 1. Patient unable to tolerate chemotherapy. 2. Patients unable to provide tumor tissue samples for testing 3. Patients with other malignant tumors or a history of other malignant tumors 4. Patients have any other reason to be unfit to participate in this study.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-07-06

1 organization

1 product

1 indication