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PD-1 Inhibitor
Pembrolizumab + Olaparib/Pemetrexed for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have not received prior systemic treatment for their advanced/metastatic NSCLC
Have stage IV nonsquamous NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial will compare two different treatments for non-small cell lung cancer. One treatment is pembrolizumab plus maintenance olaparib, and the other is pembrolizumab plus maintenance pemetrexed. The study will look at how well each treatment works and how long each treatment lasts.
Who is the study for?
This trial is for adults with stage IV nonsquamous NSCLC who haven't had prior treatments. They must have a life expectancy of at least 3 months, be able to use contraception, and not be pregnant. Participants need good organ function and no severe allergies to the drugs being tested or their ingredients.Check my eligibility
What is being tested?
The study compares two treatments: pembrolizumab combined with olaparib versus pembrolizumab with pemetrexed after initial therapy. It aims to see which combination is better for extending patients' lives without cancer progression and overall survival.See study design
What are the potential side effects?
Possible side effects include allergic reactions, fatigue, nausea, blood cell count changes (which can increase infection risk), kidney or liver function issues, shortness of breath, and potential infertility due to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had systemic treatment for my advanced lung cancer.
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My lung cancer is advanced (stage IV) and not squamous.
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I have provided a biopsy sample of my tumor that has not been treated with radiation.
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My lung cancer is not squamous cell type.
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My cancer is not suitable for EGFR, ALK, or ROS1 treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
+9 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Pemetrexed + Platinum Therapy + OlaparibExperimental Treatment5 Interventions
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4).
If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.
For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21-day cycle for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until progressive disease, physician decision or intolerable toxicity.
Group II: Pembrolizumab + Pemetrexed + Platinum Therapy + PemetrexedActive Control4 Interventions
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg intravenous (IV) on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Pemetrexed 500 mg/m^2 IV on Day 1 of each 21-day cycle (cycles 1 through 4) PLUS Platinum chemotherapy, investigator's choice: carboplatin area under the curve (AUC) 5 mg/mL/min IV on Day 1 of 21-day cycle (Cycles 1 through 4) OR cisplatin 75 mg/m^2 IV on Day 1 of 21-day cycle (Cycles 1 through 4). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive Pembrolizumab IV on Day 1 of each 21 day-cycle for up to 31 cycles PLUS maintenance pemetrexed IV 500 mg/m^2 on Day 1 of each 21-day cycle. In the Maintenance Phase, the participant continues to receive maintenance pemetrexed until progressive disease, physician decision or intolerable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Olaparib
2007
Completed Phase 4
~2140
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,817 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,566 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,475 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had systemic treatment for my advanced lung cancer.I have been treated for an autoimmune disease in the last 2 years.You have had a serious allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.My lung cancer is advanced (stage IV) and not squamous.My lung cancer is mainly squamous cell type.I have been diagnosed with MDS/AML or my condition suggests I might have it.I have provided a biopsy sample of my tumor that has not been treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.I have another cancer that has worsened in the last 3 years and needs treatment.I am not pregnant and agree to follow contraceptive guidelines for 6 months after treatment.I have been treated with drugs targeting PD-L1, PD-L2, or T-cell receptors.I haven't had palliative radiotherapy in the last week and have no side effects needing steroids.You are allergic to any parts of cisplatin, carboplatin, pemetrexed, or olaparib.You are expected to live for at least 3 more months.I have been treated with olaparib or another PARP inhibitor before.I have lung disease or needed steroids for lung inflammation.I have an immune system disorder or am on long-term steroids.You have a disease that can be measured using a specific standard.I have cancer that has spread to my brain or spinal cord.My lung cancer is not squamous cell type.I have a history of HIV, hepatitis B, or active hepatitis C.My organs are functioning well.My cancer is not suitable for EGFR, ALK, or ROS1 treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Pemetrexed + Platinum Therapy + Olaparib
- Group 2: Pembrolizumab + Pemetrexed + Platinum Therapy + Pemetrexed
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any short-term dangers associated with Pembrolizumab?
"Pembrolizumab has received a score of 3 for safety from our team at Power. This is because Pembrolizumab is in Phase 3 clinical trials, meaning that there is some data supporting both efficacy and safety."
Answered by AI
What are some of the other Pembrolizumab clinical trials that have been completed?
"There are a total of 2186 clinical trials currently being conducted that involve the use of Pembrolizumab. 488 of those trials are in Phase 3. Although most of these studies take place in Shanghai, there are a grand total of 95132 locations where research is being done on this medication."
Answered by AI
How many people are allowed to join this clinical trial?
"Unfortunately, this study is no longer seeking patients for participation. The trial was first posted on 6/28/2019 and the most recent update occurred on 8/22/2022. However, there are currently 2186 trials for Pembrolizumab enrolling patients and 1956 clinical trials for malignant neoplasms admitting patients."
Answered by AI
Are other research facilities in Canada conducting this same experiment?
"patients can enrol at the Disney Family Cancer Center (Site 0005) in Burbank, California; Medstar Good Samaritan Hospital (Site 0040) in Baltimore, Maryland; and Stronach Regional Cancer Centre (Site 0101) in Newmarket, Ontario as well as 31 other locations."
Answered by AI
What are the goals of this research?
"The purpose of this 5-year study is to observe Progression-free Survival (PFS) in patients with solid tumors, as well as secondary outcomes including Time to True Deterioration (TTD) in quality of life and the number of participants experiencing an adverse event."
Answered by AI
Are we still enrolling patients for this particular research program?
"This study, as reflected on clinicaltrials.gov, is not presently looking for patients. This trial was initially posted on 6/28/2019 and was most recently edited on 8/22/2022. There are 4142 other trials actively recruiting patients right now."
Answered by AI
Pembrolizumab is usually given to treat what type of illness?
"Pembrolizumab is primarily used to treat cancer, but it can also be useful for treating conditions such as unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
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