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Understanding Chemo-Immunotherapy Resistance in Lung Cancer (STRATUS)

This observational study, called STRATUS, aims to understand why some people with extensive-stage small cell lung cancer (ES-SCLC) or large cell neuroendocrine carcinoma (LCNEC) stop responding to their standard chemo-immunotherapy treatment. This treatment includes carboplatin or cisplatin, etoposide, and atezolizumab. Researchers will look at changes in your genes (genomic) and how your genes are expressed (epigenetic) to find out what causes this resistance. By studying these changes, the goal is to find better ways to predict who might become resistant and to develop more personalized and effective treatments in the future. You can join if you are 18-85 years old, have ES-SCLC or LCNEC, and are starting this standard treatment. The study will track these changes from when you start treatment until your disease progresses, for up to 36 months.

Study design
This is an observational study with a planned enrollment of 111 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline to disease progression, for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06717243

Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)

Recruiting
Not specifiedAges 18–85Observational
Oncology Center of Biochemical Education And Research
~111 participants
Updated 2025-03-19 on ClinicalTrials.gov
What's tested:Carboplatin/Cisplatin -Etoposide - Atezolizumab

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Genomic and Epigenetic Alterations Associated with Resistance to Chemo-Immunotherapy
Measured over Baseline to disease progression (up to 36 months).

Conditions

Small Cell Lung Cancer
Large Cell Neuroendocrine (NE) Tumors
Treatment Failure
Biomarkers / Blood
Biomarkers
Immunotherapy

Explore related trials

Large Cell Neuroendocrine CarcinomaLung Small Cell Carcinoma

Where it's being run

2 sites across 2 states
New York1
Greece1

Who to contact

kostas Nikolaos Syrigos, MD, PhD
[email protected]
+306977715137
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: Adults aged 18-85 years.
Histologically confirmed locally advanced extensive-stage small cell lung cancer (ES-SCLC).
Histologically confirmed locally advanced or metastatic large cell neuroendocrine carcinoma (LCNEC).
Treatment Plan: Eligible patients must be initiating standard-of-care chemo-immunotherapy, including platinum-based chemotherapy (cisplatin or carboplatin) combined with immune checkpoint inhibitors (atezolizumab or durvalumab).
Measurable Disease: At least one measurable or evaluable lesion as defined by RECIST 1.1 criteria.
Baseline Biospecimen Availability: Patients must agree to provide baseline blood and tumor biopsy samples for molecular and genomic analyses.
Treatment Naïve for Study Indication: Patients should not have received prior systemic therapy for ES-SCLC or LCNEC.
Life Expectancy: Estimated life expectancy of at least 3 months, as determined by the treating physician.
Follow-Up Commitment: Willingness to attend scheduled follow-up visits and provide additional biospecimens (blood and/or tissue) during treatment and at progression.
Performance Status: ECOG performance status of 0-2.
Organ Function: Adequate hematologic, renal, and hepatic function as per the treating physician's discretion.
Consent: Ability and willingness to provide written informed consent for participation in the study and collection of biospecimens (e.g., blood and tumor tissue).
Compliance with Study Protocol: Demonstrated ability and willingness to comply with all study-related procedures, including biospecimen collection and follow-up visits.
Non-Pregnant and Non-Lactating: Women of childbearing potential must have a negative pregnancy test at baseline and agree to use effective contraception during the study period.
Immunotherapy Eligibility: Patients must not have contraindications to immune checkpoint inhibitors (e.g., autoimmune diseases requiring systemic immunosuppressive therapy).
Platinum-Based Therapy Tolerance: Patients must be deemed medically fit to receive platinum-based chemotherapy (cisplatin or carboplatin) as determined by the treating physician.
No Active Infections: Patients must not have active, uncontrolled infections, including but not limited to tuberculosis, hepatitis B, hepatitis C, or HIV.
Psychosocial Stability: Patients must have adequate psychosocial support and the mental capacity to understand and provide informed consent for participation in the study.
Stable Brain Metastases: Patients with brain metastases are eligible if the metastases have been treated (e.g., surgery or radiotherapy) and are stable for at least 4 weeks prior to enrollment, as confirmed by imaging.
Steroid Use for Brain Metastases: Patients requiring corticosteroids for brain metastases are eligible only if they are on a stable or tapering dose equivalent to ≤10 mg/day of prednisone for at least 2 weeks prior to enrollment.

Exclusion

Uncontrolled Brain Metastases: Patients with untreated or progressive brain metastases causing significant neurological symptoms.
Concurrent Malignancies: Presence of any active malignancy other than ES-SCLC or LCNEC within the past 3 years, except for treated non-melanoma skin cancer or in situ cervical carcinoma.
Previous Systemic Therapy: Prior systemic chemotherapy or immunotherapy for ES-SCLC or LCNEC.
Severe Comorbidities: Significant comorbidities, such as uncontrolled cardiovascular, respiratory, or autoimmune diseases, that could interfere with study participation or treatment.
Active Infection: Patients with active infections requiring systemic therapy, including tuberculosis, hepatitis B or C, or HIV.
Pregnancy or Lactation: Pregnant or lactating women, or women of childbearing potential who are not using effective contraception.
Immunosuppressive Therapy: Patients requiring systemic immunosuppressive therapy, including high-dose corticosteroids (equivalent to \>10 mg/day prednisone), within 2 weeks prior to enrollment.
Severe Allergic Reactions: History of severe hypersensitivity reactions to any component of the planned treatment regimen, including platinum-based chemotherapy or immune checkpoint inhibitors.
Life-Threatening Conditions: Life expectancy less than 3 months, as assessed by the treating physician.
Inability to Comply: Patients unable or unwilling to adhere to study protocols, including biospecimen collection and follow-up visits.

What this trial measures

  • Number of Participants with Genomic and Epigenetic Alterations Associated with Resistance to Chemo-ImmunotherapyBaseline to disease progression (up to 36 months).

    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).