Clinical trial · Observational
Molecular Subtyping of Extensive Stage Small Cell Lung Cancer and Relevent Clinical Significance
NCT05933863CI-TRIAL-00083794MOSAICcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC,Extensive Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-(L)1 antibody immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- immunotherapy cohort
- description
- Extensive stage SCLC patients receiving first-line chemotherapy plus PD-(L)1 antibody treatment will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc.
- interventionNames
- Drug: PD-(L)1 antibody immunotherapy
- label
- chemotherapy cohort
- description
- Extensive stage SCLC patients receiving only first-line etoposide plus platinum chemotherapy will be enrolled in this cohort. Baseline tumor tissue samples and peripheral blood samples will be collected for transcriptome and immunohistochemistry analysis etc.
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 2022.4.1-2023.12.31
- description
- From the start of first-line treatment until disease progression or death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.