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Pembrolizumab + Olaparib for Squamous Cell Carcinoma of the Lung
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 not received prior systemic treatment for their advanced/metastatic NSCLC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
Study Summary
This trial will compare two treatments for people with squamous non-small cell lung cancer. One treatment will be pembrolizumab plus maintenance olaparib, and the other will be pembrolizumab plus maintenance olaparib placebo. The study's two primary hypotheses are that pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival and overall survival.
Who is the study for?
This trial is for adults with Stage IV squamous non-small cell lung cancer (NSCLC) who haven't had previous systemic treatment. Participants must have a good performance status, meaning they're relatively active and can care for themselves. They need to provide a tumor tissue sample, have no other progressing cancers or severe health conditions like autoimmune diseases or infections such as HIV, and agree to use contraception.Check my eligibility
What is being tested?
The study tests if adding olaparib after initial treatment with pembrolizumab improves progression-free survival (time without cancer worsening) and overall survival compared to using pembrolizumab with a placebo. Patients are randomly assigned to one of these two options.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, allergic responses to medication components, blood disorders like anemia from olaparib, fatigue, nausea from chemotherapy drugs used alongside the main treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had any systemic treatment for my advanced lung cancer.
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I haven't had any systemic treatment for my advanced lung cancer.
Select...
My lung cancer is confirmed to be squamous non-small cell type.
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My condition is Stage IV squamous non-small cell lung cancer.
Select...
My condition is Stage IV squamous non-small cell lung cancer.
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I have provided a sample of my tumor tissue that has not been treated with radiation.
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I have given a sample of my tumor for testing, either from an existing sample or a new biopsy.
Select...
My lung cancer is confirmed to be squamous non-small cell type.
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 European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + Carboplatin + Taxane + OlaparibExperimental Treatment5 Interventions
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). 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 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 centrally verified progressive disease, physician decision or intolerable toxicity.
Group II: Pembrolizumab + Carboplatin + Taxane + Olaparib PlaceboActive Control5 Interventions
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). 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 for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Nab-paclitaxel
2014
Completed Phase 3
~2030
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,692 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,492 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.You are expected to live for at least three more months.I have been treated with drugs targeting immune checkpoints like PD-L1 or CTLA-4.I have a history of HIV, hepatitis B, or active hepatitis C.My biopsy sample is confirmed suitable for analysis by the central lab.I haven't had any systemic treatment for my advanced lung cancer.I have lung disease or needed steroids for lung inflammation.I am not pregnant and will follow birth control advice during and after treatment for 6 months.My organs are functioning well.My organs are functioning well.I haven't had any systemic treatment for my advanced lung cancer.I agree not to donate sperm during and for 6 months after treatment.My lung cancer is confirmed to be squamous non-small cell type.I agree not to donate sperm during and for 6 months after treatment.I am allergic to carboplatin, paclitaxel, nab-paclitaxel, or olaparib.I have cancer that has spread to my brain or spinal cord.I am not pregnant and will follow birth control advice during and after treatment for 6 months.My condition is Stage IV squamous non-small cell lung cancer.My condition is Stage IV squamous non-small cell lung cancer.I have been treated with olaparib or another PARP inhibitor before.My lung cancer is not of the squamous type.I have been treated for an autoimmune disease in the last 2 years.I have provided a sample of my tumor tissue that has not been treated with radiation.I have another cancer that has worsened in the last 3 years and needs treatment.I have an immune system disorder or am on long-term steroids.I have given a sample of my tumor for testing, either from an existing sample or a new biopsy.My biopsy sample is confirmed suitable for analysis by the central lab.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.My lung cancer is confirmed to be squamous non-small cell type.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Carboplatin + Taxane + Olaparib
- Group 2: Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo
Awards:
This trial has 1 awards, including:- 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.
Is this clinical trial being performed in more than one place?
"Currently, there are 24 active recruitment sites for this trial. They are situated in cities such as Hamilton, Knoxville and Bozeman among other locations. If you wish to participate in this study, consider choosing a clinic that is close to limit travel time and costs."
Answered by AI
What are the most popular maladies that Pembrolizumab is used to target?
"Pembrolizumab is a useful medication for treating both malignant neoplasms and other issues like unresectable melanoma, microsatellite instability high, and high risk of recurrence."
Answered by AI
What is the precedence for Pembrolizumab in medical research?
"City of Hope Comprehensive Cancer Center first began studying pembrolizumab in 1997 and, as of now, there have been a total of 20028 completed trials. Out of the 2214 clinical trials that are presently ongoing, many are based in Hamilton, Ontario."
Answered by AI
Pembrolizumab has been known to cause what adverse effects in patients?
"Pembrolizumab is classified as a phase 3 drug, meaning that there have been multiple rounds of clinical trials with data supporting its efficacy and safety."
Answered by AI
What are the benefits that we hope to see from this research?
"The primary goal of this study, which will take place over the course of 3 years, is to track and document changes in Overall Survival (OS). Additionally, researchers will also be measuring secondary outcomes such as the number of participants that need to discontinue use due to adverse events (AEs). For context, an AE refers to any negative symptom experienced by a patient that is considered related or unrelated to the treatment being received. These changes will be tracked via the European Organization for Research and Treatment of Cancer's (EORTC) Quality of Life Questionnaire Lung cancer Module 13 (QLQ-LC13) Cough (Item 1)"
Answered by AI
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