What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include PD-1 inhibitors like pembrolizumab, often combined with chemotherapy. Pembrolizumab can cause side effects such as fatigue, rash, and diarrhea, with more severe effects including pneumonitis, colitis, and hepatitis. Chemotherapy side effects typically include nausea, vomiting, hair loss, and increased risk of infection due to lowered blood cell counts. When combined, these treatments can lead to a higher incidence of severe adverse events, such as grade 3-4 toxicities. The investigational agent V940's side effects are not specified, but it is important to monitor for any new or unexpected reactions when combined with pembrolizumab.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of NSCLC, both as monotherapy and in combination with chemotherapy. For instance, pembrolizumab combined with platinum-based chemotherapy has shown improved overall survival and progression-free survival in patients with advanced NSCLC. Other similar FDA-approved treatments include nivolumab (another PD-1 inhibitor) and atezolizumab (a PD-L1 inhibitor), which have been approved for use in various combinations with chemotherapy. These approvals are based on their demonstrated efficacy in improving survival outcomes in NSCLC patients.

What other types of research exist?

Promising alternatives to V940 plus pembrolizumab for NSCLC patients include: 1) Atezolizumab plus carboplatin, pemetrexed, and bevacizumab (ACBPem) as evaluated in the BTCRC-LUN 17-139 trial, showing efficacy in treatment-naïve stage IV non-squamous NSCLC patients. 2) Sintilimab plus pemetrexed and platinum, which demonstrated promising efficacy and safety in a phase 3 study for locally advanced or metastatic nonsquamous NSCLC. 3) Nivolumab combined with carboplatin, paclitaxel, and bevacizumab, as studied in the TASUKI-52 trial, for first-line treatment of advanced nonsquamous NSCLC.

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V940 + Pembrolizumab for Lung Cancer (INTerpath-002 Trial)

Phase 3

Recruiting

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

No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab

Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy

Must not have

Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma

Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~12 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new treatment combination of V940 and pembrolizumab in patients who have had surgery to remove Stage II, IIIA, or IIIB non-small cell lung cancer. The goal is to see if this new combination can help prevent the cancer from coming back. V940 and pembrolizumab work together to help the immune system find and destroy any leftover cancer cells.

Who is the study for?

This trial is for adults with Stage II, IIIA, or IIIB non-small cell lung cancer that's been surgically removed. They must have completed at least one round of standard chemo and can't have any remaining signs of cancer. People with well-controlled HIV on ART, or past hepatitis B/C with undetectable viral loads can join. Exclusions include recent investigational drug use, chronic high-dose steroids, autoimmune disease treatments within 2 years, prior PD-1/PD-L1 therapy, active infections needing systemic treatment.

What is being tested?

The study tests if adding V940 to pembrolizumab (a known immunotherapy) improves disease-free survival compared to a placebo plus pembrolizumab in patients who've had surgery for NSCLC. Participants are randomly assigned to either the V940 combo or the placebo combo after their surgery and initial chemotherapy.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), and infusion reactions during administration.

Eligibility Criteria

Inclusion Criteria

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

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It's been less than 6 months since my surgery aimed at curing my cancer and starting pembrolizumab.

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I have received at least one round of standard chemotherapy for my cancer.

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I currently show no signs of my disease.

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My lung cancer was surgically removed and confirmed to be Stage II or III.

Exclusion Criteria

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

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My cancer is either small cell lung cancer, has small cell elements, or is a specific type of neuroendocrine or sarcomatoid carcinoma.

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I am receiving or can receive radiotherapy for my lung cancer.

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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 another cancer that has gotten worse or needed treatment in the last 5 years.

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I have or had lung inflammation that needed steroids.

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I am currently on medication for an infection.

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I have been treated with drugs targeting immune checkpoints.

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I am HIV-positive and have had Kaposi's sarcoma or Multicentric Castleman's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~12 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease- Free Survival (DFS)

Secondary study objectives

Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30

Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

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

+8 more

Awards & Highlights

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: V940 + PembrolizumabExperimental Treatment2 Interventions

Participants will receive 1 mg of V940 via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Group II: Placebo + PembrolizumabActive Control2 Interventions

Participants will receive V940-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 12Eligibility 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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy and chemotherapy. Pembrolizumab, a PD-1 inhibitor, reactivates T-cells to recognize and attack cancer cells by blocking the PD-1 pathway, which cancer cells use to evade immune detection. Chemotherapy agents like pemetrexed and platinum compounds disrupt cancer cell division and DNA replication, leading to cell death. Combining these treatments can enhance efficacy by attacking cancer cells directly and boosting the immune response, potentially improving outcomes and survival rates for NSCLC patients.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.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).Non-Small Cell Lung Cancer beyond Biomarkers: The Evolving Landscape of Clinical Trial Design.