Phase 3 Lung Cancer Trial, Completed NCT03976323 Sponsor: Merck Sharp & Dohme LLC Condition: Lung Cancer
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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 (NCT03976323) enrolled 1,003 people in an initial "induction phase," where everyone received a combination of pembrolizumab, pemetrexed, and platinum-based chemotherapy. Of those, 672 completed that phase. Then, 672 participants who responded well enough moved into a "maintenance phase," where they were split into two groups: 337 people received pembrolizumab plus olaparib, and 335 received pembrolizumab plus pemetrexed. The trial was measuring two main things — how long people went without their cancer growing (called progression-free survival), and how long people lived overall (called overall survival). The reported data shows that, for the primary outcomes during the maintenance phase, the pembrolizumab plus olaparib group had a median progression-free survival of 7.1 months, compared with 8.3 months in the pembrolizumab plus pemetrexed group. Median overall survival was reported as 20.7 months in the olaparib group and 23.0 months in the pemetrexed group. (A "median" figure means half of the participants in each group reached that time point, and half did not.) For quality-of-life scores — measured using a standardised questionnaire where higher scores indicate better wellbeing — both groups showed a small decline from their starting scores over time, with the olaparib group reporting a change of −5.34 points and the pemetrexed group reporting −3.44 points. The time until participants experienced a meaningful drop (10 or more points) in their quality-of-life score was reported as approximately 19.8 months in the olaparib group and 17.3 months in the pemetrexed group. The data for adverse events (unwanted medical occurrences) was not reported in the submitted results. 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 3 Lung Cancer Trial, Completed

NCT03976323
Completed 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 have been diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), confirmed by a lab test on a tissue or cell sample.
  • Your lung cancer is at stage IV (meaning it has spread to other parts of the body).
  • Your doctor has confirmed that certain targeted treatments (aimed at EGFR, ALK, or ROS1 gene changes) are not appropriate for you.
  • Your cancer can be measured on scans according to standard guidelines.
  • You are able to provide a stored or newly taken tissue sample (biopsy) from your tumor that has not been previously treated with radiation.
  • You are expected to live for at least 3 months.
  • You are generally well enough to carry out daily activities, with little or no limitation (confirmed by a standard doctor's assessment done within 7 days before starting treatment).
  • You have not had any previous treatments for your advanced or spreading lung cancer.
  • Your liver, kidneys, and other organs are working well enough to take part.
  • If you are capable of becoming pregnant or fathering a child, you must use effective contraception during treatment and for 180 days afterwards.
  • Men must not donate sperm, and women must not donate eggs or freeze eggs for their own use, during treatment and for 180 days afterwards.

Who may not be able to join:

  • Your lung cancer is mainly of the squamous cell type.
  • You have another cancer that is currently growing or has been actively treated within the last 3 years.
  • You have active cancer spread to the brain or spinal fluid.
  • You have had a severe allergic reaction to pembrolizumab (one of the study drugs) or any of its ingredients.
  • You have a known allergy to any ingredients in cisplatin, carboplatin, pemetrexed, or olaparib (other study drugs).
  • You have an active autoimmune disease (where your immune system attacks your own body) that needed medical treatment in the past 2 years.
  • You have a condition that weakens your immune system, or you are regularly taking steroid medication.
  • You have a known history of HIV, hepatitis B, or currently active hepatitis C infection.
  • You have a lung condition called interstitial lung disease, or a history of lung inflammation that required steroid treatment.
  • You have previously been treated with olaparib or any similar drug (called a PARP inhibitor).
  • You have previously been treated with drugs that target certain immune system pathways (such as PD-L1, PD-L2, CTLA-4, or similar treatments).
  • You have or have had a blood or bone marrow condition called MDS or AML, or show signs of either condition.
  • You have a history of a second cancer, unless you completed treatment and have had no sign of cancer for at least 2 years.
  • You have had palliative radiotherapy (radiation to ease symptoms) within the last 7 days before starting the trial, or you are still experiencing side effects from radiation.

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 21 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

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Australian sites

Liverpool Hospital ( Site 1201), Liverpool, New South Wales
Southern Medical Day Care Centre ( Site 1200), Wollongong, New South Wales
Townsville General Hospital ( Site 1202), Townsville, Queensland
Monash Cancer Centre ( Site 1205), Clayton, Victoria

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
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
28 June 2019
Est. completion
7 February 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇷 Brazil 🇨🇦 Canada 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression-free Survival (PFS); 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: 21 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