BL-M14D1 plus atezolizumab vs standard therapy in first-line extensive-stage small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global Phase 3, open-label study comparing BL-M14D1 plus atezolizumab to the current standard-of-care therapy in adults with previously untreated extensive-stage SCLC. The control arm uses carboplatin, etoposide, and atezolizumab, followed by maintenance atezolizumab with or without lurbinectedin. Primary goals are to assess whether the BL-M14D1 combination improves outcomes and maintains safety. Eligible participants have confirmed ES-SCLC, good performance status, measurable disease, and adequate organ function. Key exclusions include prior platinum or etoposide for limited-stage disease and certain autoimmune or other active diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
* At least one measurable lesion based on RECIST v1.1 per investigator assessment.
* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
* Adequate organ function

Exclusion Criteria:

* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
* Participants who have received prior topoisomerase inhibitor-based ADC therapy.
* Participants with history of severe heart disease
* Participants with active autoimmune diseases and inflammatory diseases,
* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
* Other protocol-defined inclusion/exclusion criteria apply.

Where it's running

• Highlands Oncology Group
  Springdale, Arkansas, United States Recruiting
• OPN Healthcare
  Glendale, California, United States Recruiting
• MemorialCare Todd Cancer Institute
  Long Beach, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• Total Health and Research Center
  Miami, Florida, United States Recruiting
• Astera Cancer Care
  East Brunswick, New Jersey, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Loren VanPelt
• Email: loren.vanpelt@systimmune.com
• Phone: 425-453-6841

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DSP-0390 with Atezolizumab in extensive-stage small cell lung cancer

  This pilot phase Ib study tests whether adding DSP-0390 to maintenance atezolizumab after initial chemo-immunotherapy is safe and shows early signs of activity in people with extensive-stage small cell lung cancer who have not progressed.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07545954

• Stereotactic radiosurgery for lung cancer that has spread to the brain

  This study is testing if a targeted radiation treatment can help people with small cell lung cancer that has spread to their brain feel better and improve their outcomes.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT05419076

• Evaluating PC14586 for advanced solid tumors with a specific mutation

  This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.

  Recruiting at 71 sites Phase 1/2 PMV Pharmaceuticals, Inc · Irvine, California and 75 other locations · NCT04585750

• Using a new PFD3 PET tracer to find and stage small cell lung cancer

  This test will try a new PET tracer called PFD3 in adults with small cell lung cancer to see if it detects tumors and stages disease more accurately than standard FDG PET/CT.

  Recruiting Phase 1/2 Peking University First Hospital · Beijing, Beijing Municipality · NCT07508852

• Cirtuvivint plus irinotecan for relapsed small-cell lung cancer

  This trial will test whether adding cirtuvivint to irinotecan helps people with relapsed small-cell lung cancer respond better and live longer.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT07155200

• ABBV-706 plus atezolizumab versus standard first-line therapy for extensive-stage small cell lung cancer

  This trial will test whether giving ABBV-706 with atezolizumab is safer or more effective than standard first-line chemo plus atezolizumab in adults with previously untreated extensive-stage small cell lung cancer.

  Recruiting at 70 sites Phase 2 AbbVie · New Haven, Connecticut and 69 other locations · NCT07155174

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.