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Checkpoint Inhibitor

Immunotherapy + Chemotherapy for Small Cell 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 histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights

Study Summary

This trial will compare two immunotherapy treatments for small cell lung cancer. The first treatment is a combination of pembrolizumab/vibostolimab with chemotherapy. The second treatment is a combination of atezolizumab with chemotherapy. The study will measure overall survival rates to see if the first treatment is superior to the second.

Who is the study for?
This trial is for adults with a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) who need first-line therapy. Participants must have a life expectancy over 3 months, agree to contraception if applicable, and not be pregnant or breastfeeding. Exclusions include severe allergies to study drugs, recent major surgery, active infections, certain medical conditions like CNS metastases or HIV, prior SCLC treatment, and recent live vaccines.Check my eligibility
What is being tested?
The trial tests pembrolizumab/vibostolimab co-formulation with etoposide/platinum chemotherapy against atezolizumab with the same chemo in treating ES-SCLC. The goal is to see if the new drug combo improves overall survival compared to the existing treatment option.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, immune-related issues affecting organs due to pembrolizumab/vibostolimab or atezolizumab; fatigue; blood disorders; increased risk of infection from chemotherapy agents like cisplatin and carboplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have small cell lung cancer and need first-line therapy.
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My small cell lung cancer is at stage IV or has spread extensively within my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 months for reporting.

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)
Secondary outcome measures
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab/VibostolimabExperimental Treatment5 Interventions
Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Group II: AtezolizumabActive Control5 Interventions
Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Saline placebo
2005
Completed Phase 4
~22080
Etoposide
2010
Completed Phase 3
~2440
Carboplatin
2014
Completed Phase 3
~6670

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 and immune checkpoint inhibitors. Chemotherapy, often using etoposide and platinum-based drugs, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immune checkpoint inhibitors, such as Pembrolizumab (a PD-1 inhibitor) and Vibostolimab (a TIGIT inhibitor), enhance the immune system's ability to detect and destroy cancer cells. Pembrolizumab blocks the PD-1 pathway, preventing cancer cells from evading immune detection, while Vibostolimab inhibits TIGIT, further modulating the immune response to enhance anti-tumor activity. These treatments are crucial for SCLC patients as they offer a way to target the cancer more precisely and potentially improve survival rates.
Novel algorithmic approach predicts tumor mutation load and correlates with immunotherapy clinical outcomes using a defined gene mutation set.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,562 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,911 Previous Clinical Trials
5,066,214 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,795 Previous Clinical Trials
8,068,488 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05224141 — Phase 3
Small Cell Lung Cancer Research Study Groups: Pembrolizumab/Vibostolimab, Atezolizumab
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05224141 — Phase 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224141 — Phase 3
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