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NCT07144280

NCT07144280
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is either advanced and cannot be surgically removed, or has spread to other parts of the body — and a lab test has confirmed this diagnosis.
  • Your tumor has been tested and shows a certain protein called PD-L1 on at least 1% of the cancer cells, using a specific approved test.
  • You may still be eligible if your cancer has certain known genetic changes (called actionable genomic alterations, or AGAs — for example, EGFR mutations or ALK gene changes).
  • You are able to provide either a stored tumor tissue sample (ideally taken within the last 12 months after your last cancer treatment) or agree to a new biopsy if it is safe to do so.
  • If your cancer does not have known genetic changes, you must have previously received a platinum-based chemotherapy treatment and, unless there was a medical reason not to, also received an immunotherapy drug called a PD-(L)1 inhibitor — either together or one after the other.
  • If your cancer does have known genetic changes, you must have received at least one targeted therapy for those changes (if available where you live), plus a platinum-based chemotherapy at some point during your treatment.
  • In all cases, your cancer must have grown or come back during or after your most recent treatment, or you were unable to tolerate that treatment.

Who may not be able to join:

  • You have been diagnosed with another type of cancer within the past 3 years, or still have signs of a previous cancer — unless it was a very low-risk cancer such as certain early-stage skin cancers, early cervical changes, or early-stage prostate or uterine cancer.
  • You have cancer that has spread to the brain or spinal fluid area, unless the brain tumors were fully treated with surgery or radiation, you have had no sign of them growing back, treatment was completed at least 28 days before joining the trial, and you are on a low or stable dose of steroid medication (no more than the equivalent of 10 mg per day of prednisone for at least 14 days) (confirm with trial site).
  • You have a history of cancer spreading to the lining around the brain or spinal cord (called leptomeningeal metastasis).
  • You have recently received a specific type of immunotherapy drug that targets PD-L1, within a certain timeframe before joining the trial (confirm with trial site).
  • You have previously been treated with a chemotherapy drug called docetaxel, or any treatment containing a substance called MMAE.
  • Your lung cancer has a type called neuroendocrine histology or contains a neuroendocrine component.

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
Pfizer
Registry
clinicaltrials_gov
Start date
29 September 2025
Est. completion
10 March 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland Puerto Rico 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Overall Survival

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