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NCT Number: NCT05945745

Molecular Analysis and Treatment Options of SCLC

Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.

Ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.

In summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

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Key information

Who can participate

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

Inclusion criteria

  • Histologically proven diagnosis of SCLC
  • 18 years of age or older
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Histologically proven diagnosis of non-SCLC

Treatment and study plan

Chemotherapy

Drug

different treatments based on the molecular analysis

Other names: immunotherapy, targeted therapy

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 20 years

    Collect detailed clinical information on patients with SCLC via the electronic medical records

  2. Disease control rate (DCR)

    Time frame: 20 years

    Collect detailed clinical information on patients with SCLC via the electronic medical records

  3. Progression-free survival (PFS)

    Time frame: 20 years

    Collect detailed clinical information on patients with SCLC via the electronic medical records

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 20 years

    Collect detailed clinical information on patients with SCLC via the electronic medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

Molecular Landscape Analysis and Clinical Implications for SCLC

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2023
Registry last updated
Nov 29, 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.

Published trials that share one or more normalized conditions with this study.