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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03322566

NCT03322566
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced (stage IV) non-small cell lung cancer (NSCLC) confirmed by a lab test, and your cancer does not have certain specific genetic changes (called EGFR mutations, ROS1, or ALK translocations).
  • Your cancer can be measured on a scan, following specific medical guidelines (called RECIST 1.1).
  • Your doctors expect you to live for at least 3 more months.
  • You are generally well enough to carry out light activity and care for yourself (rated 0 or 1 on a standard health scale used in cancer trials).
  • Your organs (such as liver, kidneys, and blood cells) are functioning well enough to meet the trial's requirements.
  • You are able to provide a sample of your tumor tissue.

Who may not be able to join:

  • You have untreated cancer that has spread to your brain or the lining around your brain or spinal cord.
  • You have had lung inflammation (not caused by infection) in the past that needed steroid treatment, or you currently have lung inflammation or scarring.
  • You have uncomfortable fluid build-up in your abdomen or around your lungs.
  • You have had another type of cancer, unless you completed treatment at least 5 years ago with no signs of it returning.
  • You have an autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the last 2 years.
  • You have received an organ or tissue transplant from another person.
  • You have a known history of HIV infection.
  • You have active Hepatitis B or Hepatitis C (blood tests will be required to check this).
  • You have an abnormal heart reading (ECG) that the trial doctor considers medically significant.
  • You are currently using, or have recently used, certain medications or treatments that are not allowed by the trial rules (confirm with trial site).

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 2: approximately ~30% 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
Completed
Phase
Phase 2
Sponsor
Incyte Corporation
Registry
clinicaltrials_gov
Start date
9 January 2018
Est. completion
13 December 2018

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo

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