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Pembrolizumab + Chemotherapy for Small Cell Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Pembrolizumab + MK-4830 + Chemotherapy
- Group 2: Pembrolizumab + Boserolimab + Chemotherapy
- Group 3: Pembrolizumab + Lenvatinib + Chemotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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."
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