What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving PD-1 inhibitors like pembrolizumab, often combined with chemotherapy, can lead to several side effects. These include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy can add side effects like neutropenia, febrile neutropenia, nausea, fatigue, and neuropathy. The combination of these treatments may increase the risk of severe adverse effects. While specific data on TIGIT inhibitors like vibostolimab are still emerging, they are expected to have a similar profile of immune-related side effects.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC), several PD-1 inhibitors have received FDA approval. Pembrolizumab is approved for use in patients with PD-L1 expression on at least 1% of tumor cells, showing improved overall survival compared to chemotherapy. Nivolumab is another PD-1 inhibitor approved for NSCLC, demonstrating better survival rates over chemotherapy in previously treated patients. Atezolizumab, a PD-L1 inhibitor, is approved for front-line treatment in patients with high PD-L1 expression, also showing significant survival benefits. These approvals highlight the efficacy of immune checkpoint inhibitors in managing NSCLC.

What other types of research exist?

Promising alternatives to Pembrolizumab/Vibostolimab for NSCLC patients include: 1) Durvalumab plus Tremelimumab, especially for patients with high tumor mutational burden (TMB), which has shown improved OS in post-hoc analyses. 2) Tislelizumab combined with chemotherapy, which has demonstrated improved PFS and ORR in squamous cell NSCLC. 3) Sintilimab with chemotherapy, which has shown improved PFS in both squamous and nonsquamous NSCLC and is under FDA review. These alternatives offer potential benefits in terms of efficacy and safety for NSCLC patients.

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Platinum-based Chemotherapy

MK-7684A + Chemotherapy for Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC

Has not received prior systemic treatment for metastatic NSCLC

Must not have

History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 50 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new combination of two drugs with chemotherapy in patients with advanced lung cancer who haven't been treated before. The drugs help the immune system fight cancer, while chemotherapy kills cancer cells.

Who is the study for?

This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) who haven't had treatment for metastatic NSCLC, can expect to live at least 3 months, and have measurable disease. They must use effective contraception if of childbearing potential and not have HIV, Hepatitis B/C, other active cancers, CNS metastases, severe allergies to study drugs or their ingredients, certain lung conditions or infections requiring systemic therapy.

What is being tested?

The trial tests whether a combination of Pembrolizumab/Vibostolimab with chemotherapy improves overall survival compared to just Pembrolizumab plus chemotherapy in first-time treatment patients with metastatic NSCLC. It's checking the effectiveness of MK-7684A coformulation against established treatments.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs (pneumonitis), infusion-related reactions from the drug entering the body, fatigue from treatment burden on the body's resources, digestive issues like nausea or diarrhea due to gastrointestinal tract irritation by drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be stage IV.

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I haven't had systemic treatment for my advanced lung cancer.

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I am using effective birth control or am confirmed to be unable to conceive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had lung inflammation that needed steroids.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I have received treatment for cancer that has spread.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I am severely allergic to vibostolimab, pembrolizumab, or any chemotherapy components.

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I have a history of HIV, Hepatitis B, or Hepatitis C.

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I have had a transplant of tissue or an organ from another person.

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I cannot or will not take folic acid or vitamin B12 supplements.

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I am currently being treated for an infection.

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I have cancer that has spread to my brain or spinal cord.

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I have not received a live vaccine within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 50 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

Secondary study objectives

Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

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 Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13)

+15 more

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + PemetrexedExperimental Treatment6 Interventions

Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Group II: Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + PemetrexedActive Control6 Interventions

Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Carboplatin

2014

Completed Phase 3

~6120

Nab-paclitaxel

2014

Completed Phase 3

~1950

Pemetrexed

2014

Completed Phase 3

~5550

Cisplatin

2013

Completed Phase 3

~3120

0 / 14Eligibility criteria met

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) include immune checkpoint inhibitors like PD-1 inhibitors (e.g., Pembrolizumab) and TIGIT inhibitors (e.g., Vibostolimab). PD-1 inhibitors work by blocking the programmed death-1 (PD-1) receptor on T-cells, preventing cancer cells from evading the immune response. TIGIT inhibitors target the TIGIT receptor, which also plays a role in suppressing the immune system's ability to attack cancer cells. By inhibiting these checkpoints, these treatments enhance the body's immune response against cancer cells, leading to improved outcomes for NSCLC patients. This is particularly important as it offers a targeted approach to boost the immune system's natural ability to fight cancer, potentially leading to longer survival and better quality of life.

Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: a Randomized, Double-Blind, Phase 3 Study (Oncology pRogram by InnovENT anti-PD-1-11).Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12).