A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
New lung cancer drug trial for specific early-stage NSCLC patients
Plain English Summary
MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-small Cell Lung Cancer. This trial tests a new drug combination (MK-1084 plus pembrolizumab) against a placebo in patients with a specific type of non-small cell lung cancer (NSCLC) after surgery. It is for patients with completely removed Stage IIA-IIIB NSCLC that has a specific genetic mutation (KRAS G12C). Participants will receive either the new drug combination or a placebo, along with standard care, for a period after surgery. Alternative treatments may include continued chemotherapy or observation, depending on the patient's specific situation and previous treatment. The trial aims to enroll 400 participants.
Official Summary
This is a phase 3, randomized, double-blind study of adjuvant MK-1084 plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant MK-1084 plus MK-3475A to adjuvant placebo plus MK-3475A 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 Stage IIA-IIIB non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation. Patients must have had surgery to remove their tumor and have no signs of cancer remaining. Must be at least 18 years old and in good general health (ECOG 0 or 1). Cannot have active autoimmune diseases, uncontrolled cardiovascular issues, or certain other active infections or cancers. 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 main goal is to see if the new drug combination helps patients live longer without their cancer returning, compared to a placebo. The specific primary outcome measures are: Disease-free Survival (DFS) (Up to ~11 years). 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 more effective adjuvant therapies in a specific subset of early-stage lung cancer patients with a common genetic mutation, aiming to prevent cancer recurrence 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 targets a significant market segment within NSCLC, focusing on a specific mutation (KRAS G12C) where new treatments are needed, suggesting a potential for improved outcomes and market share Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if your lung cancer has the KRAS G12C mutation and if this trial is a good fit for you. Participation involves receiving study medication (either the new drug or placebo) and regular check-ups, scans, and blood tests for several years. Be prepared for potential side effects and the need for frequent clinic visits and monitoring. This trial is currently recruiting participants. The trial is being conducted at 1 site. 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
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: TRIPLE
- Enrollment: 400 participants
Interventions
- DRUG: MK-1084 — MK-1084 oral tablet
- BIOLOGICAL: MK-3475A — Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
- DRUG: Placebo — Placebo oral tablet
Primary Outcomes
- Disease-free Survival (DFS) (Up to ~11 years)
Secondary Outcomes
- Overall Survival (OS) (Up to ~11 years)
- Distant Metastasis-Free Survival (DMFS) (Up to ~11 years)
- Lung Cancer Specific Survival (LCSS) (Up to ~11 years)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score (Up to ~11 years)
- Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Up to ~11 years)
Full Eligibility Criteria
Inclusion Criteria: * Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria: * Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC * Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy. * Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation * No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention. * Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention * Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable Exclusion Criteria: * Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention * Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption) * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has not adequately recovered from major surgery or has ongoing surgical complications
Trial Locations
- Lviv Territorial Medical Union Multidisciplinary Clinical Hospital, Lviv, Ukraine
Frequently Asked Questions
What is clinical trial NCT07431827?
NCT07431827 is a Phase 3 INTERVENTIONAL study titled "MK-3475A±MK-1084 in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 400 participants.
What conditions does NCT07431827 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 NCT07431827?
The interventions being studied include: MK-1084 (DRUG), MK-3475A (BIOLOGICAL), Placebo (DRUG). MK-1084 oral tablet
What does Phase 3 mean for NCT07431827?
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 NCT07431827?
This trial is currently "Recruiting." It started on 2026-03-18. The estimated completion date is 2039-10-26.
Who is sponsoring NCT07431827?
NCT07431827 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 NCT07431827?
The trial aims to enroll 400 participants. The trial is currently recruiting and accepting new participants.
How is NCT07431827 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs triple 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 NCT07431827?
The primary outcome measures are: Disease-free Survival (DFS) (Up to ~11 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07431827 being conducted?
This trial is being conducted at 1 site, including Lviv (Ukraine).
Where can I find official information about NCT07431827?
The official record for NCT07431827 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07431827. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07431827 testing in simple terms?
This trial tests a new drug combination (MK-1084 plus pembrolizumab) against a placebo in patients with a specific type of non-small cell lung cancer (NSCLC) after surgery. It is for patients with completely removed Stage IIA-IIIB NSCLC that has a specific genetic mutation (KRAS G12C).
Why is this trial significant?
This trial addresses a critical need for more effective adjuvant therapies in a specific subset of early-stage lung cancer patients with a common genetic mutation, aiming to prevent cancer recurrence 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 NCT07431827?
Common side effects may include fatigue, nausea, diarrhea, rash, and injection site reactions. More serious risks can include immune system reactions, lung inflammation, or effects on the heart or other organs. There is a risk that the new treatment may not be more effective than the placebo and could cause unexpected side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07431827?
Ask your doctor if your lung cancer has the KRAS G12C mutation and if this trial is a good fit for you. Participation involves receiving study medication (either the new drug or placebo) and regular check-ups, scans, and blood tests for several years. Be prepared for potential side effects and the need for frequent clinic visits and monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07431827 signal from an investment perspective?
This trial targets a significant market segment within NSCLC, focusing on a specific mutation (KRAS G12C) where new treatments are needed, suggesting a potential for improved outcomes and market share 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 drug combination or a placebo, along with standard care, for a period after surgery. 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.
Related Conditions
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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.