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NCT06712355

NCT06712355
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), confirmed by a lab test on a tissue or cell sample.
  • You have not had any previous systemic (whole-body) treatment for ES-SCLC — though if you were previously treated for an earlier, limited stage of SCLC, you may still be eligible if that treatment was meant to cure the disease and it was at least 6 months ago.
  • You have at least one measurable area of cancer that can be tracked on scans, following standard measurement guidelines.
  • You are in reasonably good general health and able to carry out daily activities with little or no limitation (as measured by a standard health performance scale).
  • Your blood counts and organ functions (such as liver and kidneys) meet the levels required by the trial.

Who may not be able to join:

  • Your small cell lung cancer is a mixed type, containing more than one kind of cancer cell.
  • You have received certain cancer treatments recently — for example, some targeted drug therapies within the past 2–4 weeks, or radiation to the chest area within the past 4 weeks (confirm with trial site for exact timing rules).
  • You have previously been treated with a specific type of drug that targets blood vessel growth (anti-VEGF antibody) or a combination antibody targeting both VEGF and the immune system (PD[L]-1/VEGF bispecific antibody).
  • You have been taking steroid medications (such as prednisone at more than 10 mg per day) within the past 7 days — though some limited uses of steroids, such as inhalers or short-term allergy prevention, are allowed.
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms, are larger than 2 cm, and have not been treated.
  • You have brain or nervous system metastases that were treated but your neurological condition is not stable, or you are still on higher-dose steroids within 7 days of starting the trial.
  • Cancer has spread to the lining around your brain and spinal cord (known as leptomeningeal metastases).
  • You have high blood pressure or diabetes that is not well controlled.
  • You have a serious wound, an unhealed bone fracture, or a history of certain internal complications such as a hole in the stomach or bowel, a passage forming between organs (fistula), or an internal abdominal infection — unless at least 6 months have passed and the problem has been fully corrected or healed.
  • You have a significant risk of serious bleeding, as judged by the trial doctor.
  • You have a blockage of the major vein leading to your heart (superior vena cava syndrome) or pressure on your spinal cord that needs urgent medical treatment.

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
BioNTech SE
Registry
clinicaltrials_gov
Start date
3 February 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

10 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