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Recruiting NCT05945745

Molecular Analysis and Treatment Options of SCLC

Observational Small-cell Lung Cancer Small Cell Lung Cancer, Combined Type Small Cell Lung Carcinoma Small Cell Lung Cancer Extensive Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy.
Who it may be relevant to
Registry conditions: Small-cell Lung Cancer, Small Cell Lung Cancer, Combined Type, Small Cell Lung Carcinoma, Small Cell Lung Cancer Extensive Stage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Molecular Landscape Analysis and Clinical Implications for SCLC

Overview

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.

Interventions

  • Drug Chemotherapy
    different treatments based on the molecular analysis

Primary outcome measures

  • Objective response rate (ORR) [Time frame: 20 years]
  • Disease control rate (DCR) [Time frame: 20 years]
  • Progression-free survival (PFS) [Time frame: 20 years]
Secondary outcome measures (1)
  • Overall survival (OS) [Time frame: 20 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT05945745 · THORACIC004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗