A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

New lung cancer treatment trial for early-stage patients after surgery

NCT: NCT06077760 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2023-12-06 · Est. Completion: 2035-12-21

Plain English Summary

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-small Cell Lung Cancer. This trial tests a new combination therapy (V940 plus pembrolizumab) against a placebo plus pembrolizumab. It is for patients who have had surgery to remove Stage II, IIIA, or IIIB non-small cell lung cancer and have completed chemotherapy. Participants will receive either the new treatment or a placebo, and will be monitored closely. Standard treatment options after surgery and chemotherapy for this stage of lung cancer include continued observation or other therapies depending on specific factors. The trial aims to enroll 868 participants.

Official Summary

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with completely removed non-small cell lung cancer (Stage II, IIIA, or IIIB with N2 lymph node involvement) are eligible. You must have completed standard chemotherapy after surgery and have no signs of cancer. You must be between 18 and 85 years old. Certain medical conditions like active autoimmune disease, recent infections, or other cancers may exclude you. This trial is studying Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary goal is to see if the new treatment helps patients live longer without their cancer returning, as determined by the study doctors. The specific primary outcome measures are: Disease- Free Survival (DFS) (Up to ~78 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to find a better way to prevent lung cancer from returning after surgery and chemotherapy, addressing a critical need for improved adjuvant therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial represents a significant investment in a novel personalized cancer vaccine approach, targeting a large market of early-stage lung cancer patients with the potential for substantial impact i Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 868 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of V940 and pembrolizumab compared to standard care. Participation involves regular clinic visits for treatment, blood tests, scans, and answering quality of life questionnaires. The study treatment will be given for up to one year, with follow-up for many years to monitor outcomes. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
* Has no evidence of disease before randomization.
* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* 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.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* 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 prior to the first dose of study medication.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06077760?

NCT06077760 is a Phase 3 INTERVENTIONAL study titled "A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 868 participants.

What conditions does NCT06077760 study?

This trial investigates treatments for Non-small Cell Lung Cancer. The primary condition under study is Non-small Cell Lung Cancer.

What treatments are being tested in NCT06077760?

The interventions being studied include: Intismeran autogene (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Placebo (OTHER). IM injection

What does Phase 3 mean for NCT06077760?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06077760?

This trial is currently "Recruiting." It started on 2023-12-06. The estimated completion date is 2035-12-21.

Who is sponsoring NCT06077760?

NCT06077760 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06077760?

The trial aims to enroll 868 participants. The trial is currently recruiting and accepting new participants.

How is NCT06077760 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06077760?

The primary outcome measures are: Disease- Free Survival (DFS) (Up to ~78 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06077760 being conducted?

This trial is being conducted at 20 sites, including Anchorage, Alaska; Tucson, Arizona; Yuma, Arizona; Los Angeles, California and 16 more sites (United States).

Where can I find official information about NCT06077760?

The official record for NCT06077760 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06077760. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06077760 testing in simple terms?

This trial tests a new combination therapy (V940 plus pembrolizumab) against a placebo plus pembrolizumab. It is for patients who have had surgery to remove Stage II, IIIA, or IIIB non-small cell lung cancer and have completed chemotherapy.

Why is this trial significant?

This trial aims to find a better way to prevent lung cancer from returning after surgery and chemotherapy, addressing a critical need for improved adjuvant therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06077760?

Common side effects may include fatigue, skin rash, joint pain, and flu-like symptoms. More serious side effects can include inflammation of the lungs, liver, or other organs, which require immediate medical attention. The new treatment involves injections, which can cause pain or redness at the injection site. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06077760?

Ask your doctor about the specific risks and benefits of V940 and pembrolizumab compared to standard care. Participation involves regular clinic visits for treatment, blood tests, scans, and answering quality of life questionnaires. The study treatment will be given for up to one year, with follow-up for many years to monitor outcomes. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06077760 signal from an investment perspective?

This trial represents a significant investment in a novel personalized cancer vaccine approach, targeting a large market of early-stage lung cancer patients with the potential for substantial impact i This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either the new treatment or a placebo, and will be monitored closely. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.