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Pembrolizumab/Vibostolimab Co-Formulation for Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Klinik Penzing-2. Lungenabteilung ( Site 0502), Vienna, AustriaSmall Cell Lung CancerPembrolizumab/Vibostolimab Co-Formulation - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

2
GLSI-100
1
Pembrolizumab/Vibostolimab Co-Formulation
2
Pembrolizumab + Sacituzumab Govitecan

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: Up to approximately 60 months

Month 37
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
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
Month 26
Progression-Free Survival (PFS)
Month 37
Duration of Response (DOR)
Objective Response Rate (ORR)
Overall Survival (OS)
Month 60
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

3
GLSI-100
2
Pembrolizumab/Vibostolimab Co-Formulation
3
Pembrolizumab + Sacituzumab Govitecan

Trial Design

2 Treatment Groups

Atezolizumab
1 of 2
Pembrolizumab/Vibostolimab
1 of 2

Active Control

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab/Vibostolimab Co-Formulation · Has Placebo Group · Phase 3

Pembrolizumab/VibostolimabExperimental Group · 5 Interventions: Cisplatin, Pembrolizumab/Vibostolimab Co-Formulation, Saline placebo, Etoposide, Carboplatin · Intervention Types: Drug, Biological, Drug, Drug, Drug
AtezolizumabActiveComparator Group · 5 Interventions: Cisplatin, Saline placebo, Atezolizumab, Etoposide, Carboplatin · Intervention Types: Drug, Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1920
Saline placebo
2005
Completed Phase 4
~22090
Etoposide
2010
Completed Phase 3
~2380
Carboplatin
2014
Completed Phase 3
~6450

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 60 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,874 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,711 Previous Clinical Trials
4,967,312 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,656 Previous Clinical Trials
7,957,154 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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