Phase 2 Lung Cancer Trial, Completed NCT03322566 Sponsor: Incyte Corporation Condition: Lung Cancer
Back to Lung Cancer

Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT03322566) enrolled 233 participants across three groups: 91 people received pembrolizumab + chemotherapy + epacadostat, 87 received pembrolizumab + chemotherapy + a placebo (a dummy pill with no active ingredient), and 55 received pembrolizumab + epacadostat without chemotherapy. The main thing the trial was measuring was the proportion of participants whose tumours shrank or disappeared — called the "objective response rate" — comparing the epacadostat combination against the placebo combination. The reported data shows that 26.4% of participants in the epacadostat + chemotherapy + pembrolizumab group had their tumours shrink or disappear, compared with 44.8% in the placebo + chemotherapy + pembrolizumab group. For the secondary measures, the time participants went without their disease getting worse (called progression-free survival) was reported as 8.0 months in the epacadostat group and 8.2 months in the placebo group. Overall survival figures were not reported in the data submitted. How long responses lasted (duration of response) was not reported for the epacadostat group, while it was 7.0 months for the placebo group. Regarding adverse events (unwanted medical occurrences recorded during the study), 89 out of 91 participants in the epacadostat group and 82 out of 87 in the placebo group experienced at least one such event; 37 participants in the epacadostat group and 35 in the placebo group stopped taking the study drug due to adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Lung Cancer Trial, Completed

NCT03322566
Completed Phase 2 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

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 20 July 2026

Trial contact details on record

Principal Investigator: Lance Leopold, MD, Incyte Corporation

Australian sites

Blacktown Hospital, Blacktown, New South Wales
Chris OBrien Lifehouse, Camperdown, New South Wales
The Crown Princess Mary Cancer Centre Westmead, Westmead, New South Wales
Southern Medical Day Care Centre, Wollongong, New South Wales
MNCCI Port Macquarie Base Hospital, Port Macquarie, New South Wales (Australia)
Cairns Base Hospital, Cairns, Queensland

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

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

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 was run

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

These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 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