What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer, particularly those involving combinations of investigational agents like MK-4830, boserolimab, and lenvatinib with pembrolizumab and chemotherapy, often result in a range of side effects. These can include severe immune-related adverse events such as skin reactions, endocrine disorders, and pneumonitis. Chemotherapy-related side effects frequently include nausea, vomiting, hair loss, and myelosuppression, which can lead to anemia, neutropenia, and increased infection risk. Additionally, lenvatinib may cause hypertension, proteinuria, and fatigue. Close monitoring and management of these side effects are crucial to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that involve immune checkpoint inhibitors and chemotherapy. Atezolizumab, an anti-PD-L1 antibody, in combination with carboplatin and etoposide, is approved for first-line treatment of extensive-stage SCLC. Pembrolizumab, an anti-PD-1 antibody, has also shown efficacy in combination with chemotherapy for various cancers, including non-small cell lung cancer (NSCLC). While specific approvals for MK-4830, boserolimab, and lenvatinib in SCLC are not mentioned, these investigational agents are being studied to potentially enhance the efficacy of pembrolizumab and chemotherapy in treating extensive-stage SCLC.

What other types of research exist?

Promising, novel alternatives for enhancing the efficacy of pembrolizumab and chemotherapy in Small Cell Lung Cancer (SCLC) patients include belotecan, a camptothecin-derivative antitumor agent used as a second-line therapy for relapsed or refractory SCLC. Other potential alternatives could involve novel immunotherapy combinations or targeted therapies currently under investigation in clinical trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 5 years

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

MK-4830

2022

Completed Phase 2

~160

Boserolimab

2018

Completed Phase 1

~190

Lenvatinib

2017

Completed Phase 4

~2070

Etoposide

2010

Completed Phase 3

~2960

Cisplatin

2013

Completed Phase 3

~3120

Carboplatin

2014

Completed Phase 3

~6120

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 22Eligibility criteria met

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.