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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
Must not have
Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
Has had an allogenic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 75 months
Awards & highlights

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 below
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My scans show no signs of cancer spread beyond my lungs.
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My lung cancer is at Stage III and cannot be removed by surgery.
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My cancer can be measured and has a targetable lesion.
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My lung cancer diagnosis is confirmed by lab tests.
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My lung cancer is at stage IIIA, IIIB, or IIIC.
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I haven't had any treatment for my Stage III lung cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received drugs to boost my white blood cells within the last 28 days.
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I have received an organ or tissue transplant from another person.
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I cannot stop taking aspirin or NSAIDs for a few days around my treatment.
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I am currently being treated for an infection.
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I have been treated for an autoimmune disease in the last 2 years.
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I have had radiation therapy to my chest area before.
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I have another cancer that has gotten worse or needed treatment in the last 5 years.
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I cannot or will not take folic acid, vitamin B12, and dexamethasone.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have a history of Hepatitis B or an active Hepatitis C infection.
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I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 75 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 75 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) 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 more
Secondary 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 more

Trial 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

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 Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors, which help the immune system recognize and attack cancer cells. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 protein on T cells from binding to PD-L1 on cancer cells, thereby preventing the 'off' signal that stops T cells from attacking the cancer. Vibostolimab, a TIGIT inhibitor, works by blocking the TIGIT protein, which also helps to enhance T cell activity against cancer cells. These mechanisms are crucial for NSCLC patients as they can lead to more effective immune responses against tumors, potentially improving survival rates and outcomes.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,228 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,067,479 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,069,546 Total Patients Enrolled

Media Library

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Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05298423 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05298423 — Phase 3
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