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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
Must not have
Has a known history of, or active, neurologic paraneoplastic syndrome
Has had an allogenic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new drugs combined with existing treatments and chemotherapy to see if they can better treat patients with severe, widespread lung cancer by boosting the immune system and enhancing chemotherapy effects.

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.
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.
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 below
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I am not pregnant or breastfeeding and meet the birth control requirements.
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My small cell lung cancer is at stage IV.
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I have been diagnosed with extensive-stage small cell lung cancer and need first-line therapy.
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I can provide a sample of my tumor that hasn't been treated with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of or currently have a neurological disorder related to cancer.
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I have received an organ or tissue transplant from another person.
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I have cancer that has spread to my brain or spinal cord.
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I am currently being treated for an infection.
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I have been treated with drugs targeting immune checkpoints.
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I have a history of inflammatory bowel disease.
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I have not had major surgery in the last 3 weeks.
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I have had treatment for small cell lung cancer, including trials.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
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My scans show my tumor is affecting major blood vessels or has hollow areas.
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I have another cancer that is getting worse or was treated in the last 3 years.
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I have fluid buildup in my abdomen, chest, or around my heart.
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I have a condition that affects how my body absorbs medication taken by mouth.
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I have not had a live vaccine in the last 30 days.
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I have a history of HIV, Hepatitis B, or active Hepatitis C.
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I have a severe fistula.
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I have been treated for an autoimmune disease in the last 2 years.
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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
Boserolimab
2018
Completed Phase 1
~190
Lenvatinib
2017
Completed Phase 4
~2040
Etoposide
2010
Completed Phase 3
~2960
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immune checkpoint inhibitors, and investigational agents. Chemotherapy, such as etoposide combined with platinum-based drugs, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immune checkpoint inhibitors like pembrolizumab and nivolumab block proteins (PD-1/PD-L1) that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Investigational agents such as MK-4830, boserolimab (MK-5890), and lenvatinib (MK-7902) are being studied for their potential to further enhance the efficacy of pembrolizumab and chemotherapy. MK-4830 targets immune-suppressive pathways, boserolimab is an anti-TIGIT antibody that may enhance T-cell activity, and lenvatinib inhibits multiple receptor tyrosine kinases involved in tumor growth and angiogenesis. These treatments are crucial for SCLC patients due to the aggressive nature of the disease and its tendency to develop resistance to standard therapies, necessitating novel approaches to improve outcomes.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,220 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,978 Previous Clinical Trials
5,177,909 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,864 Previous Clinical Trials
8,082,355 Total Patients Enrolled

Media Library

Boserolimab (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04924101 — Phase 2
Small Cell Lung Cancer Research Study Groups: Pembrolizumab + MK-4830 + Chemotherapy, Pembrolizumab + Boserolimab + Chemotherapy, Pembrolizumab + Lenvatinib + Chemotherapy
Small Cell Lung Cancer Clinical Trial 2023: Boserolimab Highlights & Side Effects. Trial Name: NCT04924101 — Phase 2
Boserolimab (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924101 — Phase 2
~41 spots leftby Jul 2026