Phase 3 Lung Cancer Trial, Recruiting NCT07099898 Sponsor: GlaxoSmithKline Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT07099898
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be an adult (18 years or older, or the minimum legal adult age in your country) at the time you sign the consent form.
  • You must have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread beyond one lung), confirmed by a lab test on a tissue or cell sample.
  • You must have already received one prior treatment that included a platinum-based chemotherapy drug combined with a type of immunotherapy (called a PD-(L)1 inhibitor) for at least 2 rounds, followed by a break of more than 30 days, and your cancer must have continued to grow or spread after that treatment. Previous treatment with a specific drug called tarlatamab is also allowed.
  • You must have at least one measurable area of cancer that can be tracked on scans, as assessed by the study doctor.
  • You must be able to understand and agree to the study requirements by signing a consent form.
  • You must have body organs functioning well enough to participate, and you must be generally well enough to carry out daily activities with no or minimal limitations (as measured by a standard doctor's assessment scale).

Who may not be able to join:

  • You may not join if your small cell lung cancer has been identified as a specific rare subtype called "complex SCLC" or "transformed SCLC."
  • You may not join if your small cell lung cancer was originally diagnosed as "limited stage" (meaning it had not spread widely at the time of first diagnosis).
  • You may not join if you have previously received a type of targeted drug treatment called an antibody-drug conjugate (ADC) containing a TOPO1 inhibitor, or any treatment that targets a protein called B7-H3.
  • You may not join if you have a known allergy or sensitivity to any ingredients in the study drug, which in the doctor's opinion would make it unsafe for you to participate.
  • You may not join if you have severe, uncontrolled, or currently active heart or blood vessel problems.
  • You may not join if you have had significant or uncontrolled bleeding in the month before starting the study.
  • You may not join if you have an active infection that needs treatment with medication, or if you are known to have HIV.
  • You may not join if you have brain metastases (cancer that has spread to the brain) causing symptoms, untreated brain progression, or cancer that has spread to the lining of the brain, brainstem, or spinal cord.
  • You may not join if you currently have or have previously had a serious lung inflammation condition (called interstitial lung disease or pneumonitis) that required high-dose steroid treatment.
  • You may not join if you have significant or uncontrolled lung or breathing problems, such as uncontrolled asthma, COPD, or restricted lung function.
  • You may not join if you currently have active Hepatitis B or Hepatitis C (liver infections caused by viruses).

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 6 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 877-379-3718

Australian sites

GSK Investigational Site, Blacktown, New South Wales
877-379-3718
GSK Investigational Site, St Leonards, New South Wales
877-379-3718
GSK Investigational Site, Nedlands, Western Australia
877-379-3718

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
11 August 2025
Est. completion
5 November 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom

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: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov