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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 belowSelect...
I have small cell lung cancer and need first-line therapy.
Select...
My small cell lung cancer is at stage IV or has spread extensively within my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
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 moreTrial 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
~22170
Etoposide
2010
Completed Phase 3
~2440
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,378 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,103 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,036 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of or currently have a neurological disorder related to cancer.I haven't had major surgery in the last 3 weeks and have recovered from any previous procedures.You have a cancer that can be measured using specific guidelines.I am not pregnant, breastfeeding, and if able to have children, I use effective birth control or practice abstinence.I have received an organ or tissue transplant from another person.I have another cancer that is getting worse or was treated in the last 3 years.I have received treatment for Small Cell Lung Cancer.I have small cell lung cancer and need first-line therapy.I have not had a live vaccine in the last 30 days.You have had a very serious allergic reaction to the study drug or any of its ingredients in the past.I have fluid buildup in my abdomen or around my lungs.I have cancer that has spread to my brain or spinal cord.I am currently being treated for an infection.You have been diagnosed with HIV.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have or had lung inflammation that needed steroids.I have a serious health condition that is not under control.I will not need any cancer treatment other than the study for my small cell lung cancer.I agree to use contraception and not donate sperm.You are expected to live for more than 3 months.I have a history of Hepatitis B or active Hepatitis C.I have been treated for an autoimmune disease in the last 2 years.My small cell lung cancer is at stage IV or has spread extensively within my lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/Vibostolimab
- Group 2: Atezolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
With how many test subjects is this research being conducted?
"In order to fully run this clinical trial, 450 willing and eligible patients are required. The study is being conducted out of multiple sites, two examples being University of Virginia Cancer Center (Site 0019) in Charlottesville, Virginia and Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) which is located in Boca Raton, Florida."
Answered by AI
What are the FDA's thoughts on Pembrolizumab/Vibostolimab Co-Formulation?
"Pembrolizumab/Vibostolimab Co-Formulation is being trialed in Phase 3, so there is some evidence of efficacy and it has been tested for safety multiple times."
Answered by AI
Are we able to enroll patients in this research trial at this time?
"The clinical trial is recruiting patients, as indicated on the website clinicaltrials.gov. The first posting was on 3/24/2022, with the most recent update being on 11/4/2022."
Answered by AI
Are there a lot of hospitals participating in this clinical trial within the city limits?
"University of Virginia Cancer Center ( Site 0019) in Charlottesville, Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014) in Boca Raton, and Hattiesburg Clinic Hematology/Oncology ( Site 0003) are three of the nine locations where this trial is currently taking place."
Answered by AI
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