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

Launched by ONCOLOGY CENTER OF BIOCHEMICAL EDUCATION AND RESEARCH · Dec 1, 2024

Keywords

ClinConnect Summary

The STRATUS trial is a study designed to understand why some patients with extensive-stage small cell lung cancer (ES-SCLC) or large cell neuroendocrine carcinoma (LCNEC) do not respond well to chemo-immunotherapy treatments. These are aggressive types of lung cancer that often initially respond to treatment but can become resistant, meaning the cancer grows despite therapy. The researchers aim to identify specific genetic and molecular changes in blood and tumor samples that might help predict which patients will continue to benefit from treatment and which ones will face challenges. By learning more about these resistance mechanisms, the study hopes to develop more personalized and effective treatment options in the future.

To participate in this trial, individuals need to be between 18 and 85 years old and have a confirmed diagnosis of ES-SCLC or LCNEC. They should be starting standard chemotherapy combined with immune therapy and have not received other treatments for their cancer before. Participants will provide blood and tumor samples before starting treatment and will have follow-up visits every 9 weeks to monitor their progress. This study is important because it aims to create new tools to help doctors better understand and treat lung cancer, ultimately improving outcomes for patients facing these challenging conditions.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.