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Platinum-based Chemotherapy
Pembrolizumab + Chemoradiation +/- Olaparib for Stage III 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
Has no evidence of metastatic disease indicating Stage IV NSCLC
Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 72 months
Awards & highlights
Study Summary
This trial will compare the efficacy of three different treatments for unresectable, locally advanced NSCLC. Arm 1 will receive pembrolizumab concurrently with chemoradiation, followed by pembrolizumab with olaparib placebo. Arm 2 will receive the same treatment as Arm 1, but will take olaparib instead of the placebo. Arm 3 will receive concurrent chemoradiation therapy followed by durvalumab. The primary hypothesis is that pembrolizumab with concurrent chemoradiation and olaparib is superior to durvalumab with respect to PFS and OS.
Who is the study for?
This trial is for adults with Stage III NSCLC who haven't had previous treatments for this stage, can't have surgery to cure it, and don’t have metastatic (Stage IV) disease. They should be expected to live at least 6 months, able to perform daily activities with little or no help (ECOG 0-1), and must agree to use contraception.Check my eligibility
What is being tested?
The study tests pembrolizumab combined with chemoradiation followed by either pembrolizumab plus olaparib placebo or just olaparib versus chemoradiation followed by durvalumab. It aims to see if the first two methods are better than the third in improving survival without cancer progression.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs, infusion-related reactions, fatigue, nausea, blood cell changes increasing infection risk. Specifics depend on each drug combination but may also involve lung issues like pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer has not spread to other parts of my body.
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My lung cancer is at stage IIIA, IIIB, or IIIC.
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I cannot have surgery to cure my Stage III lung cancer.
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My lung cancer diagnosis was confirmed through lab tests.
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My lung cancer diagnosis is confirmed by lab tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 72 months
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) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Secondary outcome measures
Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
+13 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: pembrolizumab+chemoradiation→pembrolizumab+olaparib placeboExperimental Treatment8 Interventions
Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
Group II: pembrolizumab+chemoradiation→pembrolizumab+olaparibExperimental Treatment8 Interventions
Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year.
Group III: chemoradiation→durvalumabActive Control7 Interventions
Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140
Pemetrexed
2014
Completed Phase 3
~5250
Thoracic Radiotherapy
2003
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,952 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,701 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,610 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer has not spread to other parts of my body.I have had radiation therapy to my chest area before.I have been treated with specific immune therapy for cancer.My lung cancer is at stage IIIA, IIIB, or IIIC.You are expected to live for at least 6 months.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I am currently being treated for active tuberculosis.I cannot swallow pills or have a gut condition affecting drug absorption.You have a disease that can be measured using a specific set of guidelines.I have not had treatments for Stage III non-small cell lung cancer.I am a man and agree to use birth control and not donate sperm for 90 days after my last treatment dose.My lung cancer is of the small cell type or has small cell elements.I am not pregnant or breastfeeding and agree to use contraception for the required time after treatment.I cannot stop taking aspirin or NSAIDs, except for low-dose aspirin, for 2 days before and after treatment.I cannot have surgery to cure my Stage III lung cancer.I have received an organ or tissue transplant from another person.My lung cancer diagnosis was confirmed through lab tests.My lung cancer diagnosis is confirmed by lab tests.I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.I have or had lung inflammation that needed steroids.My lung function tests are within normal ranges.I have another cancer besides skin or superficial bladder cancer that needed treatment in the last 5 years.I have a history of Hepatitis B or an active Hepatitis C infection.I have provided a sample of my tumor for testing.I am fully active or restricted in physically strenuous activity but can do light work.I have received treatments to boost my white blood cells within the last 28 days.I have been treated for an autoimmune disease in the last 2 years.I have lost more than 10% of my weight in the last 3 months.I have not received a live vaccine within the last 30 days.You have been diagnosed with HIV/AIDS.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.You have a severe allergic reaction (Grade 3 or higher) to the study drug or any of its ingredients.I have heart conditions that are not under control or I was born with long QT syndrome.I cannot or will not take folic acid, vitamin B12, and dexamethasone with pemetrexed.I will need cancer treatment other than the study offers while participating.I have not had major surgery within the last 4 weeks, except for vascular access placement.I am taking medication that strongly or moderately affects my liver enzyme levels and cannot stop during the study.My organs are functioning well.I am currently being treated for an infection.I have been treated with olaparib or another PARP inhibitor before.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
- Group 2: pembrolizumab+chemoradiation→pembrolizumab+olaparib
- Group 3: chemoradiation→durvalumab
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.
What are some of the conditions that Pembrolizumab is used to manage?
"Pembrolizumab is the standard medication for melanoma. Pembrolizumab can also be used to treat neoplasm metastasis, malignant melanoma of skin, and merkel cell cancer."
Answered by AI
What other medical studies have there been with Pembrolizumab?
"Pembrolizumab was first trialed in 1997 by City of Hope Comprehensive Cancer Center. 3012 trials have completed since then and as of now, 2916 are actively ongoing. A large number clinical trials for this medication are based out of Fullerton, Indiana."
Answered by AI
What are the risks of Pembrolizumab for patients?
"Pembrolizumab has received a score of 3 for safety. This rating comes from the fact that there is some efficacy data as well as multiple rounds of safety data because it is in Phase 3 clinical trials."
Answered by AI
Would it be possible to find out how many different health care facilities are running this research project in town?
"This study is currently running at St Joseph Heritage Healthcare-Oncology ( Site 0088) in Fullerton, Franciscan St. Francis Health ( Site 0031) in Lafayette, and Rutgers Cancer Institute of New jersey ( Site 0054) in New Brunswick as well as 30 other locations."
Answered by AI
Why was this clinical trial designed, and what are its goals?
"The sponsor of the study, Merck Sharp & Dohme LLC, reports that the primary outcome will be Overall Survival (OS), which will be measured over a time frame of Up to approximately 48 months. Additionally, this trial will assess secondary outcomes including Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score, Discontinuation Rate of Study Intervention Due to an Adverse Event (AE), and TTD in Cough Using the EOTRC QLQ-LC13 Item 1 Score."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Fox Chase Cancer Center ( Site 0063)
What portion of applicants met pre-screening criteria?
Met criteria
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