Actively Recruiting
Genomic and Methylation Signatures in Extensive-Stage Small Cell Lung Cancer and Metastatic Large Cell Neuroendocrine Carcinoma Undergoing Chemo-Immunotherapy: A Prospective Observational Study
Led by Oncology Center of Biochemical Education And Research · Updated on 2025-03-19
111
Participants Needed
2
Research Sites
36 weeks
Total Duration
On this page
Sponsors
O
Oncology Center of Biochemical Education And Research
Lead Sponsor
N
National and Kapodistrian University of Athens
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how genetic and epigenetic factors contribute to resistance against chemo-immunotherapy in adults with extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC). These aggressive lung cancers have limited treatment options, and most patients develop resistance to therapy within a few months, leading to disease progression and poor survival. The study aims to discover molecular changes that cause resistance, which may help guide future personalized treatments. Participants receive standard chemo-immunotherapy treatments, including platinum-based chemotherapy (cisplatin or carboplatin) combined with immune checkpoint inhibitors like atezolizumab or durvalumab. Biospecimens such as blood and tumor tissue are collected before treatment, during therapy every 9 weeks, and at disease progression, including optional re-biopsies. These samples are analyzed for genomic, epigenetic, methylation, and transcriptomic signatures to identify patterns related to treatment resistance and tumor evolution. Throughout the three-year study, participants undergo clinical evaluations, imaging scans, and blood draws to monitor tumor response and disease status. Researchers assess circulating tumor cells, tumor DNA, and immune markers to understand how these relate to progression and survival. This detailed monitoring aims to identify biomarkers that predict resistance and improve treatment strategies for these difficult cancers, supporting the development of more precise and effective therapies.
CONDITIONS
Brief Title
Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-85 years
- Histologically confirmed extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC)
- Starting standard chemo-immunotherapy with platinum-based chemotherapy and immune checkpoint inhibitors
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- Willing to provide baseline blood and tumor biopsy samples
- No prior systemic therapy for ES-SCLC or LCNEC
- Estimated life expectancy of at least 3 months
- ECOG performance status of 0-2
- Adequate organ function as determined by physician
- Able and willing to provide written informed consent
- Able and willing to comply with study procedures and follow-up visits
- Non-pregnant and non-lactating; women of childbearing potential must have negative pregnancy test and use effective contraception
- Eligible for immune checkpoint inhibitors without contraindications
- Medically fit to receive platinum-based chemotherapy
- No active, uncontrolled infections including tuberculosis, hepatitis B or C, or HIV
- Adequate psychosocial support and mental capacity for consent
- Stable brain metastases treated and stable for at least 4 weeks
- Corticosteroid use for brain metastases stable or tapering at ≤10 mg/day prednisone for at least 2 weeks
You will not qualify if you...
- Untreated or progressive brain metastases causing significant neurological symptoms
- Active malignancies other than ES-SCLC or LCNEC within past 3 years, except treated non-melanoma skin cancer or in situ cervical carcinoma
- Prior systemic chemotherapy or immunotherapy for ES-SCLC or LCNEC
- Severe comorbidities interfering with participation or treatment
- Active infections requiring systemic therapy including tuberculosis, hepatitis B or C, or HIV
- Pregnancy or lactation, or women not using effective contraception
- Systemic immunosuppressive therapy including high-dose corticosteroids (>10 mg/day prednisone) within 2 weeks prior to enrollment
- History of severe allergic reactions to planned treatment components
- Life expectancy less than 3 months
- Unable or unwilling to comply with study protocols including biospecimen collection and follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 36 months
Participants are observed throughout their standard chemo-immunotherapy treatment for extensive-stage small cell lung cancer or metastatic large cell neuroendocrine carcinoma. Blood samples and imaging studies are collected to monitor tumor and biomarker changes.
Visits every 9 weeks for blood sample collection and imaging assessments
Duration - Variable, following progression during the study period
For participants whose disease progresses, repeat biopsies and blood samples are collected to analyze molecular changes associated with treatment resistance.
Additional visits at time of disease progression for biopsies and blood sampling
Trial Site Locations
Total: 2 locations
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
2
3rd Department of Medicine, National and Kapodistrian University of Athens, Sotiria Hospital
Athens, Greece, 11527
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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