Study on BL-M14D1 and Atezolizumab vs Standard Treatment for First-Line Extensive-Stage Small Cell Lung Cancer
Sponsor: SystImmune Inc.
ClinicalTrials ID:NCT07625644
This clinical trial is comparing a new treatment combination of BL-M14D1 and Atezolizumab with the current standard treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) who have not received prior treatment.
Patient Parameters
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Program Overview
The purpose of this study is to determine if a new treatment combination of BL-M14D1 and Atezolizumab is more effective and safe compared to the standard treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) who have not been treated before. The standard treatment includes chemotherapy drugs carboplatin and etoposide, along with Atezolizumab, followed by maintenance therapy with Atezolizumab, with or without another drug called lurbinectedin.
Description
This is a Phase 3 study conducted globally, where researchers are testing a new treatment combination of BL-M14D1 and Atezolizumab against the current standard treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) who have not received any prior treatment. The standard treatment involves chemotherapy with carboplatin and etoposide, combined with Atezolizumab, and then continuing with Atezolizumab alone or with lurbinectedin as maintenance therapy. The study aims to evaluate how well the new treatment works and its safety compared to the standard approach.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with extensive-stage small cell lung cancer (ES-SCLC) that has not been treated before.
- Eligible to receive a chemotherapy regimen that includes a platinum-based drug and an anti-PD-L1 inhibitor.
- Have at least one tumor that can be measured by scans.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have received any platinum or etoposide treatment for limited-stage small cell lung cancer (LS-SCLC) within the last 6 months.
- Have previously received treatment with a topoisomerase inhibitor-based ADC therapy.
- Have a history of severe heart disease.
- Have active autoimmune or inflammatory diseases.
- Have other cancers, except for certain skin cancers or cancers that have been treated successfully and have not returned for at least 3 years.
- Other specific criteria as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Los Alamitos Hematology/Oncology Medical Group | 91203 | Glendale | California |
| MemorialCare Todd Cancer Institute | 90806 | Long Beach | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| Total Health and Research Center | 33176 | Miami | Florida |
| Astera Cancer Care | 08816 | East Brunswick | New Jersey |
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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