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NCT Number: NCT05933863

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100042, China

About this study

This retrospective observational study examines the predictive value of transcriptome-based molecular subtyping of extensive stage SCLC for PD-1/PD-L1 inhibitor efficacy and explores immune microenvironment differences between subtypes to uncover immunotherapy resistance mechanisms. Patients with extensive stage SCLC receiving first-line standard treatment are enrolled, and baseline tumor tissue and peripheral blood samples are collected for transcriptome sequencing and immunohistochemistry (IHC). Based on results, patients are classified into four molecular subtypes, and treatment efficacy and safety are recorded. The study compares the efficacy between SCLC subtypes to determine if molecular typing predicts immunotherapy efficacy and investigates immune microenvironment differences between subtypes to uncover resistance mechanisms. Treatment regimens follow first-line extensive stage SCLC guidelines, including cisplatin+etoposide or carboplatin+etoposide and PD-(L)1 inhibitors, with options determined by the supervising physician.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Progression-free survival

    Time frame: 2022.4.1-2023.12.31

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

Secondary outcomes

  1. Overall survival

    Time frame: 2022.4.10-2024.12.31

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

  2. Objective response rate

    Time frame: 2022.4.10-2023.12.31

    The tumor size was calculated by computed tomography or magnetic resonance Imaging scan, the best response was evaluated based on Response Evaluation Criteria in Solid Tumors (RECISTVersion1.1)

  3. molecular subtyping and tumor microenvironment biomarkers

    Time frame: 2022.4.10-2023.12.31

    The molecular subtyping was carried out based on transcripsome sequencing following the method in published article PMID: 33482121, the tumor microenvironment biomarkers include tumor infiltrated immune cells and specific gene expression evaluated by transcripsome and Multiplex immunohistochemical analysis etc.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Acronym: MOSAIC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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