Study Summary
This trial is testing a new cancer treatment that uses two drugs, pembrolizumab and vibostolimab, in combination with standard chemotherapy and radiation therapy. The new treatment is being compared to standard chemotherapy and radiation therapy followed by a different drug, durvalumab. The primary hypotheses are that the new treatment will improve progression-free survival and overall survival in patients with non-small cell lung cancer.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
4 Primary · 26 Secondary · Reporting Duration: Up to approximately 75 months
Month 75
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
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) For All Participants
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
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) For All Participants
Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Month 55
Progression-Free Survival (PFS) For All Participants
Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Month 75
Duration of Response (DOR) For All Participants
Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience at Least One Adverse Event (AE)
Objective Response Rate (ORR) For All Participants
Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Overall Survival (OS) For All Participants
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Month 75
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS ≥1%
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS ≥1%
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
chemotherapy+radiotherapy+durvalumab
1 of 2
pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
1 of 2
Active Control
Experimental Treatment
784 Total Participants · 2 Treatment Groups
Primary Treatment: pembrolizumab/vibostolimab · No Placebo Group · Phase 3
pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapyExperimental Group · 7 Interventions: pembrolizumab/vibostolimab, carboplatin, etoposide, paclitaxel, cisplatin, pemetrexed, thoracic radiotherapy · Intervention Types: Biological, Drug, Drug, Drug, Drug, Drug, Radiation
chemotherapy+radiotherapy+durvalumabActiveComparator Group · 7 Interventions: carboplatin, etoposide, paclitaxel, durvalumab, cisplatin, pemetrexed, thoracic radiotherapy · Intervention Types: Drug, Drug, Drug, Biological, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
carboplatin
2010
Completed Phase 3
~4790
etoposide
1994
Completed Phase 3
~9300
paclitaxel
1996
Completed Phase 3
~4310
cisplatin
1997
Completed Phase 3
~3290
pemetrexed
2005
Completed Phase 3
~5000
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 75 months
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,339 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,711 Previous Clinical Trials
4,966,713 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,656 Previous Clinical Trials
7,956,619 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are expected to live for at least 6 more months.
You are not willing or able to take folic acid, vitamin B12, and dexamethasone.
Frequently Asked Questions
Do pembrolizumab/vibostolimab have any long-term side effects?
"Pembrolizumab/vibostolimab's safety is estimated to be a 3. This comes from it being a Phase 3 trial, which has some data supporting efficacy and multiple rounds of safety data." - Anonymous Online Contributor
Unverified Answer
Are we able to sign up for this testing program at the present moment?
"That is correct, the online clinicaltrials.gov database has that this study, which was first posted on May 3rd 2022, presently recruiting participants. The research team hopes to enroll 784 patients from 7 different locations." - Anonymous Online Contributor
Unverified Answer