Chemo-Immunotherapy Resistance Markers for Small Cell Lung Cancer
(STRATUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why some lung cancer patients stop responding to chemo-immunotherapy, a treatment combining chemotherapy and immune system boosters. It focuses on adults with extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC), both aggressive lung cancers. Researchers will examine patterns in patients' genes and other markers in blood and tumor samples to find clues about resistance to treatment. Suitable candidates for the trial include those who have just started this type of treatment and have not received previous therapy for these specific cancers. The goal is to find ways to predict and overcome treatment resistance, potentially leading to better, personalized care. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering a chance to contribute to advancements in personalized cancer care.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that patients should not have contraindications to immune checkpoint inhibitors and should not be on high-dose corticosteroids. It's best to discuss your current medications with the study team to ensure they don't interfere with the trial requirements.
What prior data suggests that this study's methods are safe?
Research has shown that treatments combining chemotherapy and immunotherapy for extensive-stage small cell lung cancer (ES-SCLC) are generally well-tolerated. One study found that adding atezolizumab to chemotherapy was effective and safe in real-world settings. Another study demonstrated that including atezolizumab or durvalumab in the initial treatment significantly improved patient outcomes without major safety issues.
For metastatic large cell neuroendocrine carcinoma (LCNEC), combining immune checkpoint inhibitors with platinum-based chemotherapy appears promising. Studies have indicated better patient outcomes with manageable side effects. In one study, a patient experienced a complete tumor response with this treatment, suggesting it can be both effective and safe.
Overall, these treatments have been tested in many patients, focusing on balancing effectiveness and safety. While side effects can occur, they are usually manageable with medical care.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover why some patients with extensive-stage small cell lung cancer (ES-SCLC) and large cell neuroendocrine carcinoma (LCNEC) become resistant to chemo-immunotherapy. Unlike current treatments that primarily focus on standard chemotherapy and immune checkpoint inhibitors, this trial digs deeper into the genomic and epigenetic factors that might influence treatment outcomes. By analyzing blood and tumor samples at different stages of treatment, researchers hope to identify unique genetic and molecular signatures that predict resistance. These insights could lead to more personalized and effective treatment strategies for these challenging cancers.
What evidence suggests that this study's findings could lead to more effective treatments for ES-SCLC and LCNEC?
This trial includes two separate cohorts studying different cancers. For extensive-stage small cell lung cancer (ES-SCLC), research has shown that combining chemotherapy with immune checkpoint inhibitors, such as atezolizumab or durvalumab, is promising. Studies have found that adding these drugs to standard chemotherapy can extend the lives of patients with ES-SCLC and improve their overall health outcomes. Meanwhile, for large cell neuroendocrine carcinoma (LCNEC), using similar immune-boosting drugs with chemotherapy has also provided significant benefits. This combination can slow cancer growth more effectively than chemotherapy alone. These treatments are important because they offer new hope for patients with these aggressive cancers.23467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants provide blood and tumor tissue samples to establish baseline molecular profiles
Treatment Monitoring
Participants undergo follow-up visits every 9 weeks during treatment for blood sample collection and imaging tests
Disease Progression Assessment
For patients with progressive disease, repeat biopsies and blood samples are collected to identify resistance-associated changes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Carboplatin/Cisplatin - Etoposide
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
This cohort includes adults diagnosed with metastatic large cell neuroendocrine carcinoma (LCNEC). Participants will receive standard-of-care systemic therapies, such as platinum-based chemotherapy (cisplatin or carboplatin), with or without immune checkpoint inhibitors, based on physician discretion. Biospecimens, including blood (for circulating tumor DNA and circulating tumor cells) and tumor tissue, will be collected at baseline, during treatment, and upon disease progression. These samples will undergo molecular analysis to identify genomic, epigenetic, and transcriptomic changes associated with treatment resistance and progression.
This cohort includes adults with extensive-stage small cell lung cancer (ES-SCLC) receiving standard-of-care chemo-immunotherapy, such as platinum-based chemotherapy (cisplatin or carboplatin) combined with immune checkpoint inhibitors (atezolizumab or durvalumab). The study collects biospecimens, including blood (for circulating tumor DNA and circulating tumor cells) and tumor tissue, at baseline, during treatment, and at progression. These samples are analyzed to identify genomic, epigenetic, and transcriptomic signatures associated with treatment resistance. Insights gained will improve understanding of resistance mechanisms and guide personalized treatment strategies for ES-SCLC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oncology Center of Biochemical Education And Research
Lead Sponsor
Sotiria General Hospital
Collaborator
National and Kapodistrian University of Athens
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Citations
EP.13B.03 Real-World Outcomes of Platinum ...
Atezolizumab and durvalumab were approved alongside platinum-based chemotherapy as 1L treatment for ES-SCLC, based on data from two phase 3 trials, ...
Atezolizumab and platinum-based chemotherapy in ...
Conclusions: Atezolizumab combined with chemotherapy in ES-SCLC showed good tolerability and effectiveness in real world setting. Our data are ...
Chemo-Immunotherapy in First Line Extensive Stage Small ...
Recent studies report improved progression-free survival (PFS) and overall survival (OS) with combined ICI and chemotherapy in ES-SCLC.
First-Line Atezolizumab plus Chemotherapy in Extensive- ...
The addition of atezolizumab to chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer resulted in significantly longer overall ...
Durvalumab Plus Platinum-Etoposide in Extensive-Stage ...
In the phase 3 CASPIAN study, first-line durvalumab plus etoposide combined with either carboplatin or cisplatin (EP) significantly improved ...
Efficacy and Safety Evaluation of Immune Checkpoint ...
This is a comparison of 1st line Chemotherapy for small cell lung cancer. There was a difference in efficacy for brain metastasis.
PD-L1 inhibitors combined with chemotherapy for ...
Immunotherapy with atezolizumab and durvalumab has significantly advanced the treatment of extended-stage small cell lung cancer (esSCLC). We ...
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