Your session is about to expire
← Back to Search
Alkylating agents
Pembrolizumab/Vibostolimab + Chemoradiotherapy for Non-Small Cell Lung Cancer
Phase 3
Recruiting
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 no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
Is determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 75 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with Stage III Non-small Cell Lung Cancer (NSCLC) who haven't had previous treatments. They must have a life expectancy of at least 6 months, be able to provide a tumor tissue sample, and not show signs of cancer spread in scans. Participants should be physically capable (ECOG status 0 or 1) and cannot have an active infection, recent vaccines, other cancer treatments within the last month, autoimmune diseases treated in the past two years, or certain medical conditions.Check my eligibility
What is being tested?
The study tests pembrolizumab/vibostolimab with chemoradiotherapy (cCRT), followed by more pembrolizumab/vibostolimab against cCRT followed by durvalumab. It aims to see if the first combination is better for extending survival without cancer progression and overall survival in patients whose tumors express PD-L1 protein.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs due to pembrolizumab/vibostolimab or durvalumab; chemotherapy may cause nausea, fatigue, hair loss; radiotherapy might lead to skin irritation and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show no signs of cancer spread beyond my lungs.
Select...
My lung cancer is at Stage III and cannot be removed by surgery.
Select...
My cancer can be measured and has a targetable lesion.
Select...
My lung cancer diagnosis is confirmed by lab tests.
Select...
My lung cancer is at stage IIIA, IIIB, or IIIC.
Select...
I haven't had any treatment for my Stage III lung cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 75 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 75 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) For All Participants
Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Progression-Free Survival (PFS) For All Participants
+1 moreSecondary outcome measures
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%
+23 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapyExperimental Treatment7 Interventions
For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray [Gy] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to ~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Group II: chemotherapy+radiotherapy+durvalumabActive Control7 Interventions
For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following cCRT, participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.
Investigator's choice of chemotherapy: cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m^2 on Day 1 of Cycle 1 and 45 mg/m^2 on Days 1, 8, 15 of Cycles 2-3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cisplatin
1997
Completed Phase 3
~3290
pemetrexed
2005
Completed Phase 3
~5000
etoposide
1994
Completed Phase 3
~9300
carboplatin
2010
Completed Phase 3
~4790
paclitaxel
1996
Completed Phase 3
~4310
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,351 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,890 Previous Clinical Trials
5,059,481 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,956 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My scans show no signs of cancer spread beyond my lungs.I have received drugs to boost my white blood cells within the last 28 days.I have received an organ or tissue transplant from another person.I have not had major surgery in the last 4 weeks or have fully recovered from it if I did.You are expected to live for at least 6 months.I cannot stop taking aspirin or NSAIDs for a few days around my treatment.My lung cancer is at Stage III and cannot be removed by surgery.I am currently being treated for an infection.I have been treated for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.I have had radiation therapy to my chest area before.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is small cell lung cancer or has small cell elements.I have another cancer that has gotten worse or needed treatment in the last 5 years.My cancer can be measured and has a targetable lesion.My lung cancer diagnosis is confirmed by lab tests.I will need cancer treatment other than the study's while participating.My lung cancer is at stage IIIA, IIIB, or IIIC.I haven't had any treatment for my Stage III lung cancer.I cannot or will not take folic acid, vitamin B12, and dexamethasone.I have provided a sample of my tumor for testing.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a history of Hepatitis B or an active Hepatitis C infection.You have been diagnosed with HIV.I have or had lung inflammation that needed steroids.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy
- Group 2: chemotherapy+radiotherapy+durvalumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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."
Answered by AI
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."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger