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NCT06717243 · ClinicalTrials.gov registry record
Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)
A clinical trial of Small-cell Lung Cancer and Immunotherapy, sponsored by Oncology Center of Biochemical Education And Research.
- Recruiting
- Registry status
- 111
- Enrollment target
- 2
- Study locations
NCT06717243: Recruiting study of Small-cell Lung Cancer and Immunotherapy, sponsored by Oncology Center of Biochemical Education And Research.
NCT06717243 is a study of Small-cell Lung Cancer and Immunotherapy that is actively recruiting participants, run by Oncology Center of Biochemical Education And Research. The registered enrollment target is 111 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (52% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06717243, a study of Small-cell Lung Cancer and Immunotherapy, is actively recruiting participants, sponsored by Oncology Center of Biochemical Education And Research.
- RECRUITING
- Registry status
- 111 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this observational study is to understand how genomic and epigenetic factors contribute to resistance against chemo-immunotherapy in adults diagnosed with extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC). Both ES-SCLC and LCNEC are aggressive forms of lung cancer with limited treatment options and poor prognosis. While initial responses to chemo-immunotherapy are often promising, most patients develop resistance within a few months, resulting in disease progression and limited survival. This study seeks to explore the molecular and cellular changes that drive resistance, providing insights that could guide more personalized and effective treatment strategies in the future. The study focuses on identifying genomic and methylation signatures, as well as analyzing circulating tumor cells (CTCs) and tumor DNA (ctDNA), to better understand the mechanisms of resistance. By collecting and analyzing these biomarkers over time, researchers aim to identify patterns that distinguish patients who benefit long-term from therapy from those who experience early resistance. These findings may pave the way for new diagnostic tools and therapies to predict and overcome resistance to chemo-immunotherapy. The main questions this study seeks to answer are: Are there specific genomic or methylation patterns that predict resistance to chemo-immunotherapy in ES-SCLC and LCNEC? How are circulating tumor cells (CTCs) and tumor DNA (ctDNA) associated with disease progression, treatment response, and survival? What molecular differences exist between patients who respond long-term and those who develop resistance early in their treatment? Participants will: Provide blood and tumor tissue samples before treatment to establish baseline molecular profiles. Undergo follow-up visits every 9 weeks during treatment, where additional blood samples and imaging tests will be collected to monitor disease progression and treatment
Primary Outcome
Identification of genomic, methylation, and other epigenetic alterations that are associated with resistance to standard-of-care chemo-immunotherapy (platinum-based chemotherapy combined with immune checkpoint inhibitors) in patients with extensive-stage small cell lung cancer (ES-SCLC) and metastatic large cell neuroendocrine carcinoma (LCNEC).
Conditions Studied
Interventions
- DRUG Carboplatin/Cisplatin -Etoposide - Atezolizumab
Study Locations (2)
New York
- Icahn School of Medicine at Mount Sinai - New York
Other
- 3rd Department of Medicine, National and Kapodistrian University of Athens, Sotiria Hospital - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2025-02-20 |
| Est. Completion | 2028-12-01 |
What NCT06717243 shows while recruiting
NCT06717243 is an observational study that tracks outcomes without assigning an intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (52% lower).
The record links to 6 conditions, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Carboplatin/Cisplatin -Etoposide - Atezolizumab is the first listed.
NCT06717243 reports a single indexed study location in New York, Other.
Frequently Asked Questions
What is clinical trial NCT06717243 about?
NCT06717243 is a clinical study titled "Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)". The goal of this observational study is to understand how genomic and epigenetic factors contribute to resistance against chemo-immunotherapy in adults diagnosed with extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC). Both ES-SCLC and LCNEC ar...
What is the current status of trial NCT06717243?
This trial is currently recruiting. The enrollment target is 111 participants. The study started on 2025-02-20. Estimated completion is 2028-12-01.
What conditions does trial NCT06717243 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer, Immunotherapy, Biomarkers, Treatment Failure, Biomarkers / Blood.
What interventions are being tested in trial NCT06717243?
The interventions under investigation include: Carboplatin/Cisplatin -Etoposide - Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT06717243?
This trial is sponsored by Oncology Center of Biochemical Education And Research, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06717243 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06717243's enrollment target sits among peer trials
111 33rd of 79 higher than 47 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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