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

NCT05933863 | Completed

• 1 other identifier: 2021YJZ97
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

SCLC,Extensive Stage

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From the start of first-line treatment until disease progression or death due to any cause

  2022.4.1-2023.12.31

Secondary Outcomes (3)

• Overall survival

  2022.4.10-2024.12.31

• Objective response rate

  2022.4.10-2023.12.31

• molecular subtyping and tumor microenvironment biomarkers

  2022.4.10-2023.12.31

Study Arms (2)

immunotherapy cohort

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.

Drug: PD-(L)1 antibody immunotherapy

chemotherapy cohort

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.

Interventions

PD-(L)1 antibody immunotherapy DRUG

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.

immunotherapy cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes adults (18-100 years) with untreated advanced SCLC. Eligible patients have an ECOG score of 0\~2, an expected survival \>3 months, and can provide tumor biopsy samples for transcripsome testing. They must have received first-line chemotherapy or chemotherapy combined with a PD-L1 inhibitor. Participants are divided into two arms: Chemotherapy (80-100 cases) and Immunotherapy+chemotherapy (80-100 cases). Exclusion criteria include intolerance to chemotherapy, inability to provide tumor tissue samples, presence/history of other malignant tumors, and other reasons deeming them unfit for the study.

You may qualify if:

• The enrolled subjects shall meet all the following conditions at the same time.
• Male or female, aged 18 to 100 years
• Patients with untreated advanced small cell lung cancer clearly diagnosed by histopathology
• Be able to provide tumor biopsy tissue sample for molecular analysis
• Eastern Cooperative oncology Group (ECOG) score: 0\~2
• Expected survival of more than 3 months.
• 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
• Received first-line chemotherapy or chemotherapy＋PD-(L)1 inhibitor and be able to provide complete treatment information and efficacy evaluation results.
• Voluntary signed informed consent and expected good compliance.

You may not qualify if:

• Those meeting any of the following conditions may not be included.
• Patient unable to tolerate chemotherapy.
• Patients unable to provide tumor tissue samples for testing
• Patients with other malignant tumors or a history of other malignant tumors
• Patients have any other reason to be unfit to participate in this study.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100042, China

Location

Study Officials

• Minglei Zhuo, Physician

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 6, 2023
• Study Start: March 29, 2022
• Primary Completion: July 18, 2024
• Study Completion: December 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-11

Locations

CN (1)