A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

New Lung Cancer Trial Tests Advanced Immunotherapy After Surgery

NCT: NCT06623422 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2024-10-21 · Est. Completion: 2038-01-26

Plain English Summary

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Carcinoma, Non-Small-Cell Lung. This trial tests if adding a new immunotherapy drug (V940) to a standard immunotherapy (pembrolizumab) after surgery can help prevent lung cancer from returning. It is for patients with a specific type of non-small cell lung cancer (Stage II to IIIB) that did not fully respond to chemotherapy and immunotherapy before surgery. Participation involves receiving either the new drug combination or a placebo with standard immunotherapy after surgery, with regular check-ups and tests. Alternatives include standard post-surgery treatment, additional chemotherapy, or other clinical trials, depending on the patient's specific situation and doctor's recommendation. The trial aims to enroll 680 participants.

Official Summary

The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer (Stage II, IIIA, or IIIB) that has been surgically removed. Must not have had a complete response to chemotherapy and immunotherapy before surgery. Must not have specific genetic mutations (EGFR, ALK) that are targeted by other therapies. Patients must be in good general health with a performance status of 0 or 1. This trial is studying Carcinoma, Non-Small-Cell Lung, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if patients in the new drug group live longer without their cancer returning compared to those receiving a placebo, meaning the new treatment might offer better protection agai The specific primary outcome measures are: Disease-Free Survival (DFS) (Up to ~97 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 addresses a critical need for better treatments for lung cancer patients whose tumors are not completely eliminated by initial therapy, aiming to improve long-term survival by preventing re 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 Carcinoma, Non-Small-Cell Lung, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in lung cancer treatment, with a large market for adjuvant therapies; success could position Merck's V940 as a key player, potentially leading to a strong c Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 680 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific stage and type of your lung cancer, and if your tumor showed a complete response to neoadjuvant treatment. Understand that you will be randomly assigned to receive either the new drug combination or a placebo, and that participation involves regular clinic visits, scans, and potential side effect monitoring. Discuss any other medical conditions or medications you have, as these could affect your eligibility or safety in the trial. 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 histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* 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

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, or a pancoast tumor
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Received prior neoadjuvant therapy for their current NSCLC diagnosis
* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
* Received prior treatment with a cancer vaccine
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06623422?

NCT06623422 is a Phase 3 INTERVENTIONAL study titled "A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 680 participants.

What conditions does NCT06623422 study?

This trial investigates treatments for Carcinoma, Non-Small-Cell Lung. The primary condition under study is Carcinoma, Non-Small-Cell Lung.

What treatments are being tested in NCT06623422?

The interventions being studied include: Pembrolizumab (BIOLOGICAL), Cisplatin (DRUG), Carboplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG). IV Infusion

What does Phase 3 mean for NCT06623422?

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 NCT06623422?

This trial is currently "Recruiting." It started on 2024-10-21. The estimated completion date is 2038-01-26.

Who is sponsoring NCT06623422?

NCT06623422 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 NCT06623422?

The trial aims to enroll 680 participants. The trial is currently recruiting and accepting new participants.

How is NCT06623422 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 NCT06623422?

The primary outcome measures are: Disease-Free Survival (DFS) (Up to ~97 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06623422 being conducted?

This trial is being conducted at 20 sites, including Gilbert, Arizona; Tucson, Arizona; Fullerton, California; Long Beach, California and 16 more sites (United States).

Where can I find official information about NCT06623422?

The official record for NCT06623422 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06623422. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06623422 testing in simple terms?

This trial tests if adding a new immunotherapy drug (V940) to a standard immunotherapy (pembrolizumab) after surgery can help prevent lung cancer from returning. It is for patients with a specific type of non-small cell lung cancer (Stage II to IIIB) that did not fully respond to chemotherapy and immunotherapy before surgery.

Why is this trial significant?

This trial addresses a critical need for better treatments for lung cancer patients whose tumors are not completely eliminated by initial therapy, aiming to improve long-term survival by preventing re 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 NCT06623422?

Common side effects of immunotherapy can include fatigue, rash, and diarrhea; specific side effects of V940 are still being studied. The combination therapy may increase the risk of immune-related side effects, where the immune system attacks healthy tissues. Potential risks include reactions at the infusion site and general side effects associated with chemotherapy drugs used in the neoadjuvant setting. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06623422?

Ask your doctor about the specific stage and type of your lung cancer, and if your tumor showed a complete response to neoadjuvant treatment. Understand that you will be randomly assigned to receive either the new drug combination or a placebo, and that participation involves regular clinic visits, scans, and potential side effect monitoring. Discuss any other medical conditions or medications you have, as these could affect your eligibility or safety in the trial. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06623422 signal from an investment perspective?

This trial targets a significant unmet need in lung cancer treatment, with a large market for adjuvant therapies; success could position Merck's V940 as a key player, potentially leading to a strong c 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?

Participation involves receiving either the new drug combination or a placebo with standard immunotherapy after surgery, with regular check-ups and tests. 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.