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Immunomodulatory Agent
Pembrolizumab + Chemotherapy for Small Cell Lung Cancer
Phase 2
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
Female participant is eligible if not pregnant or breastfeeding, and meets contraceptive requirements
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 years
Awards & highlights
Study Summary
This trial is testing 3 different cancer drugs in combination with each other and with chemotherapy, to see if they're effective at treating small cell lung cancer.
Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer who need first-line therapy. They must not be pregnant or breastfeeding, agree to contraception, have good organ function and performance status, and no prior treatments for SCLC. Exclusions include previous immunotherapy, certain heart conditions, uncontrolled diseases, recent major surgery, active infections like HIV/Hepatitis B/C, and other factors that could affect participation.Check my eligibility
What is being tested?
The study tests new drugs (MK-4830, boserolimab/MK-5890 & lenvatinib/MK-7902) combined with pembrolizumab & chemotherapy in treating ES-SCLC. It's an exploratory trial without formal hypothesis testing to assess the safety and effectiveness of these combinations as a first treatment option.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to pembrolizumab or investigational agents; typical chemo side effects like nausea/vomiting; increased blood pressure from lenvatinib; plus risks associated with any additional medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding and meet the birth control requirements.
Select...
My small cell lung cancer is at stage IV.
Select...
I have been diagnosed with extensive-stage small cell lung cancer and need first-line therapy.
Select...
I can provide a sample of my tumor that hasn't been treated with radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Six-Month Progression-Free Survival (PFS) as Assessed by BICR per RECIST 1.1
Secondary outcome measures
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale (Items 29 and 30) at Week 19
Duration of Response (DOR) as Assessed by BICR per RECIST 1.1
Number of Participants Who Discontinued Study Treatment Due to an AE
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab + MK-4830 + ChemotherapyExperimental Treatment5 Interventions
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Group II: Pembrolizumab + Lenvatinib + ChemotherapyExperimental Treatment5 Interventions
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Group III: Pembrolizumab + Boserolimab + ChemotherapyExperimental Treatment5 Interventions
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Etoposide
2010
Completed Phase 3
~2440
Cisplatin
2013
Completed Phase 3
~1940
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
4,582,163 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,963 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,768 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a major heart issue or blood clot in the past year.I have a history of or currently have a neurological disorder related to cancer.I am not pregnant or breastfeeding and meet the birth control requirements.Your heart's electrical activity (QT interval) is longer than normal.I had a gastrointestinal perforation less than 6 months ago.I don't have any health issues that could affect the study's results or my participation.I have received an organ or tissue transplant from another person.I am a man willing to use contraception and not donate sperm.My small cell lung cancer is at stage IV.I have cancer that has spread to my brain or spinal cord.You must have a measurable disease that can be seen on a scan and confirmed by a separate review.I am currently being treated for an infection.I have been treated with drugs targeting immune checkpoints.Your heart's pumping ability is below the normal range.I have a serious health condition that is not under control.You have more than 1 gram of protein in your urine over a 24-hour period.I have a history of inflammatory bowel disease.I have not had major surgery in the last 3 weeks.I have had treatment for small cell lung cancer, including trials.I have not had a serious wound, ulcer, or bone fracture that hasn't healed in the last 28 days.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.My scans show my tumor is affecting major blood vessels or has hollow areas.I have another cancer that is getting worse or was treated in the last 3 years.I have fluid buildup in my abdomen, chest, or around my heart.I have a condition that affects how my body absorbs medication taken by mouth.I have not had a live vaccine in the last 30 days.I haven't had any major bleeding or blood clot events in the last 3 months.I have a history of HIV, Hepatitis B, or active Hepatitis C.I have been diagnosed with extensive-stage small cell lung cancer and need first-line therapy.I can provide a sample of my tumor that hasn't been treated with radiation.I have not coughed up blood in the last 3 weeks.I will not need any cancer treatment other than the study for my small cell lung cancer.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well enough for treatment.I have a severe fistula.I have been treated for an autoimmune disease in the last 2 years.I have or had lung inflammation that needed steroids.My blood pressure is ≤150/90 mm Hg and stable for the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + MK-4830 + Chemotherapy
- Group 2: Pembrolizumab + Boserolimab + Chemotherapy
- Group 3: Pembrolizumab + Lenvatinib + Chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many healthcare facilities are actively participating in this research project?
"Through this medical study, Georgia Cancer Specialists (Site 0106) in Atlanta, Cleveland Clinic-Taussig Cancer Center ( Site 0116) in Cleveland and MFSMC-HJWCI-Oncology Research ( Site 0128) in Baltimore are all recruiting patients. Additionally, 17 other locations have been added to the list of participating sites."
Answered by AI
What medical purposes is MK-4830 administered for?
"MK-4830 is a viable treatment option for both chronic illnesses and acute conditions such as hodgkin disease, metastatic cutaneous squamous cell carcinoma, and refractory testicular cancer."
Answered by AI
Could you please provide an overview of all trials conducted with regards to MK-4830?
"Since its inception in 1997 at the City of Hope Comprehensive Cancer Center, MK-4830 has been studied extensively. As of now, there have already been 2183 trials completed and with an additional 2145 actively enrolling patients; many of these studies are taking place in Atlanta, Georgia."
Answered by AI
What end goal is this research endeavor hoping to reach?
"Merck Sharp & Dohme Corp., the sponsor of this study, is measuring the primary outcome for up to five years. This objective involves Six-Month Progression-Free Survival (PFS) as Assessed by BICR per RECIST 1.1; additionally, secondary outcomes such as Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale at Week 19, Duration of Response (DOR), and PFS will be evaluated."
Answered by AI
What detrimental impacts has MK-4830 been linked to in humans?
"MK-4830 recently transitioned to a Phase 2 trial, indicating there is evidence of safety but not efficacy. We rate the risk associated with this drug as a 2."
Answered by AI
Is this project currently open to recruitment?
"As indicated on clinicaltrials.gov, this research project is actively looking for participants. The trial began recruitment on July 15th 2021 and the most recent update was made at the end of November 2022."
Answered by AI
What is the current enrollment capacity for this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was first published on July 15th 2021, is presently recruiting participants. Around 120 individuals need to be recruited from a total of 17 sites."
Answered by AI
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