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Chemotherapy
Chemoradiation + Pembrolizumab/Olaparib for Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has pathologically confirmed Small Cell Lung Cancer (SCLC) excluding mixed tumors with small cell and non-small cell elements
Is not expected to require tumor resection during the course of the study
Must not have
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 82 months
Awards & highlights
Summary
This trial will compare overall survival and progression free survival of two groups of patients with advanced solid tumors - those who receive concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib, and those who receive concurrent chemoradiation therapy alone.
Who is the study for?
This trial is for adults with newly diagnosed, treatment-naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) who have a good performance status and can be treated with radiation. They must not have received any prior treatments for LS-SCLC or have any history of certain diseases like HIV, Hepatitis B/C, or autoimmune disease requiring recent treatment. Participants should not be pregnant, must agree to use contraception, and cannot have participated in another investigational study recently.
What is being tested?
The trial tests if adding pembrolizumab (an immunotherapy drug) and olaparib (a PARP inhibitor) to standard chemoradiation therapy improves survival without cancer progression compared to chemoradiation alone. Patients are randomly assigned to receive either the new combination of drugs or a placebo alongside their regular cancer treatment.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs, infusion reactions from the drug entering the body, fatigue, blood disorders that affect how your blood clots or fights infection, digestive issues like nausea or diarrhea, and an increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with pure Small Cell Lung Cancer.
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I am not expected to need surgery to remove a tumor during the study.
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I have not had any treatment for my small cell lung cancer.
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My small cell lung cancer is in an early stage and can be treated with radiation.
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My scans show no signs of cancer spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently being treated for an infection.
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I have a history of HIV, Hepatitis B, or active Hepatitis C.
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I have had lung inflammation that needed steroids.
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I have or might have a blood disorder like MDS or AML.
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I have been treated with olaparib or another PARP inhibitor before.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been treated with specific immune therapy for cancer.
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I have not had major surgery within the last 4 weeks, except for procedures to place a vascular access.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 82 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 82 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival: the time from randomization to death due to any cause
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first
Secondary study objectives
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
+15 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BIDExperimental Treatment7 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.
Group II: Group A - Pembrolizumab 200 mgExperimental Treatment7 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.
Group III: Group C (Pembrolizumab and Olaparib Matching Placebos)Placebo Group6 Interventions
Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab 200 mg
2013
Completed Phase 3
~930
Etoposide 100 mg/m^2
2013
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,176,001 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,673 Total Patients Enrolled
Medical Director, MDStudy DirectorMerck Sharp & Dohme LLC
80 Previous Clinical Trials
15,928 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for an infection.I have been diagnosed with pure Small Cell Lung Cancer.I am not pregnant and will follow birth control advice during and after the study.I have a history of HIV, Hepatitis B, or active Hepatitis C.I have another cancer besides the one being studied that has needed treatment in the last 5 years.I have had lung inflammation that needed steroids.You are expected to live for at least 6 more months.I can provide a sample of my tumor before treatment starts.I have or might have a blood disorder like MDS or AML.I will not breastfeed during and for 4 months after the study if I receive Pembrolizumab, or for 1 week if I receive Olaparib.I have been treated with olaparib or another PARP inhibitor before.My organs are functioning well.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have been treated for an autoimmune disease in the last 2 years.I am not expected to need surgery to remove a tumor during the study.I am fully active or restricted in physically strenuous activity but can do light work.I will not donate sperm during and after the treatment for a specified period.You have at least one specific area of your tumor that can be measured according to certain guidelines.I have been treated with specific immune therapy for cancer.I have not had any treatment for my small cell lung cancer.My small cell lung cancer is in an early stage and can be treated with radiation.I am 18 years old or older.My scans show no signs of cancer spread.I have not had major surgery within the last 4 weeks, except for procedures to place a vascular access.You have a severe allergic reaction (Grade 3 or higher) to the study treatment or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Group C (Pembrolizumab and Olaparib Matching Placebos)
- Group 2: Group A - Pembrolizumab 200 mg
- Group 3: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID
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.
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