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NCT07472517

NCT07472517
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with small cell lung cancer that has spread widely in the body (called "extensive-stage"), and this has been confirmed through a tissue test (biopsy).
  • You have not had any previous systemic (whole-body) cancer treatments for this widespread stage of the disease — or, if you were treated at an earlier stage, that treatment finished more than 6 months before your current diagnosis.
  • A stored sample of your tumour tissue is available and can be sent to a central laboratory for testing, and the results of that test must be ready before you are enrolled in the trial.
  • If you have cancer that has spread to the brain but is not causing symptoms, you may still be eligible — either if brain treatment was completed at least 14 days ago and you have been stable without steroids or seizure medicines for at least 7 days, or if your brain metastases are untreated but stable and you have not needed steroids or seizure medicines for at least 28 days.
  • You are generally able to carry out light activity and care for yourself (a standard fitness scale score of 0 or 1, confirm with trial site).
  • You are able to continue receiving the standard first-line chemotherapy and immunotherapy combination (carboplatin, etoposide, and atezolizumab) within 28 days of starting your first treatment cycle.
  • You are able to receive full doses of all three standard treatments (carboplatin, etoposide, and atezolizumab) according to approved guidelines.

Who may not be able to join:

  • You have cancer that has spread to the lining around the brain or spinal cord (a condition called leptomeningeal disease or carcinomatous meningitis).
  • You have previously received any treatment specifically targeting a protein called DLL3 (such as certain antibody or cell-based therapies).
  • You have received any radiotherapy (radiation treatment) to any part of your body within the 14 days before enrolment.
  • You still have significant side effects from previous cancer treatments that have not improved to a mild level — with some specific exceptions (confirm with trial site).
  • You have an active autoimmune disease (where your immune system attacks your own body) or a history of one that requires ongoing systemic treatment such as steroids or immune-suppressing medicines — though certain milder conditions like stable thyroid problems or controlled Type 1 diabetes may be acceptable depending on the doctor's assessment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Boehringer Ingelheim
Registry
clinicaltrials_gov
Start date
13 April 2026
Est. completion
9 September 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇲🇾 Malaysia 🇲🇽 Mexico Moldova 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States 🇻🇳 Vietnam

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Overall survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov