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Taking peoplePhase 3

Compares BL-M14D1 plus atezolizumab with standard treatment in untreated small cell lung cancer

Tests BL-M14D1 with atezolizumab in adults with untreated extensive-stage lung cancer.

Plain-language title generated from the registry record
Registry title: BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

Key facts

Where
Bialystok, Gdynia, Katowice, Lodz, and Prabuty, PolandSee the 5 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with small cell lung cancer that has spread (extensive stage) and who have not yet had treatment for it.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Extensive-stage small cell lung cancer, confirmed by tissue or cell tests, as first treatment. At least one lesion that can be measured on scans (RECIST v1.1).
Earlier treatment
No earlier treatment for extensive-stage disease. Must be able to receive platinum-based chemotherapy together with an anti-PD-L1 drug. Cannot have had a topoisomerase inhibitor-based ADC therapy before.

Main reasons for not taking part

  • Platinum or etoposide treatment for limited-stage small cell lung cancer within the last 6 months
  • Earlier topoisomerase inhibitor-based ADC therapy
  • History of severe heart disease
  • Active autoimmune or inflammatory disease
  • Other cancers, with a few exceptions such as some skin cancers or cancers treated with a disease-free period of at least 3 years

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Which best describes your lung cancer?
  • Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?

Source: NCT07625644, who can take part

Where in Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, Raka Pluca i Chorob WewnetrznychBialystok, PolandNot yet recruiting
  • Szpitale Pomorskie Spolka z ograniczona odpowiedzialnoscia, Oddzial Onkologii i Radioterapii - Dzial Onkologii KlinicznejGdynia, PolandNot yet recruiting
  • Oddzial Onkologii KlinicznejKatowice, PolandNot yet recruiting
  • Instytut "Centrum Zdrowia Matki Polki", Klinika OnkologiiLodz, PolandNot yet recruiting
  • Szpital Specjalistyczny w Prabutach Spolka z ograniczona odpowiedzialnoscia, Oddzial pulmonologiiPrabuty, PolandNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
SystImmune Inc.
Trial code
NCT07625644
Record updated
15 October 2026
Original description
The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).Read full original descriptionShow less

A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer

The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Inclusion: 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: 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 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; Participants with history of severe heart disease; Participants with active autoimmune diseases and inflammatory diseases,; Other protocol-defined inclusion/exclusion criteria apply.

ClinicalTrials.gov NCT07625644