A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
New lung cancer trial tests targeted therapy with immunotherapy vs. chemo
Plain English Summary
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-small Cell Lung Cancer. This study tests a new drug called calderasib combined with an immunotherapy drug (pembrolizumab) against a standard chemotherapy treatment for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and has spread or cannot be removed by surgery. Participants will be randomly assigned to receive either the new combination therapy or chemotherapy, and will receive either pills or injections/infusions. Alternative treatments include other targeted therapies, immunotherapies, and chemotherapy regimens, depending on the specific type and stage of lung cancer. The trial aims to enroll 675 participants.
Official Summary
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has spread or cannot be surgically removed. Must have a specific genetic mutation in their cancer called KRAS G12C. Patients with well-controlled HIV are eligible. Cannot have had prior treatment for their advanced or metastatic lung cancer, or have certain other medical conditions like active inflammatory bowel disease, uncontrolled heart/brain disease, or active autoimmune disease. 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 outcome measures how long patients live without their cancer getting worse, which means the study aims to see if the new treatment can help patients live longer without their lung cancer p The specific primary outcome measures are: Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Up to approximately 48 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 significant unmet need for patients with KRAS G12C-mutant NSCLC, a group with limited effective first-line treatment options, by investigating a novel combination of targeted th 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 Phase 3 trial, sponsored by Merck, signals a significant investment in a novel combination therapy for a specific lung cancer subtype, aiming to capture a share of the growing oncology market wit Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 675 participants suggests significant investment in this program.
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 regular clinic visits for assessments, receiving study medications, and monitoring for side effects. You will be randomly assigned to one of two treatment groups, and you will know which treatment you are receiving. 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
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 675 participants
Interventions
- DRUG: Calderasib — Administered as an oral tablet
- BIOLOGICAL: Pembrolizumab (+) Berahyaluronidase alfa — Administered as a SC injection
- DRUG: Pemetrexed — Administered as an IV Infusion
- DRUG: Cisplatin — Administered as an IV Infusion
- DRUG: Carboplatin — Administered as an IV Infusion
Primary Outcomes
- Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Up to approximately 48 months)
Secondary Outcomes
- PFS in All Participants (Up to approximately 48 months)
- Overall Survival (OS) in Participants with PD-L1 TPS ≥1% (Up to approximately 62 months)
- OS in Participants in All Participants (Up to approximately 62 months)
- Overall Response Rate (ORR) in All Participants (Up to approximately 48 months)
- ORR in Participants with PD-L1 TPS ≥1% (Up to approximately 48 months)
Full Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c * If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has a gastrointestinal disorder affecting absorption * Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in the past 2 years * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy except those specified by protocol * Has history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Trial Locations
- Central Alabama Research ( Site 0108), Birmingham, Alabama, United States
- Stamford Hospital ( Site 0126), Stamford, Connecticut, United States
- Mount Sinai Cancer Center ( Site 0137), Miami Beach, Florida, United States
- New England Cancer Specialists ( Site 0139), Westbrook, Maine, United States
- New York Oncology Hematology, P.C. ( Site 0119), Albany, New York, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111), Lancaster, Pennsylvania, United States
- Blue Ridge Cancer Care ( Site 0144), Roanoke, Virginia, United States
- Instituto Alexander Fleming ( Site 0311), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300), Mar del Plata, Buenos Aires, Argentina
- Hospital Italiano de Cordoba ( Site 0308), Córdoba, Argentina
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07190248?
NCT07190248 is a Phase 3 INTERVENTIONAL study titled "A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 675 participants.
What conditions does NCT07190248 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 NCT07190248?
The interventions being studied include: Calderasib (DRUG), Pembrolizumab (+) Berahyaluronidase alfa (BIOLOGICAL), Pemetrexed (DRUG), Cisplatin (DRUG), Carboplatin (DRUG). Administered as an oral tablet
What does Phase 3 mean for NCT07190248?
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 NCT07190248?
This trial is currently "Recruiting." It started on 2025-10-08. The estimated completion date is 2032-08-06.
Who is sponsoring NCT07190248?
NCT07190248 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 NCT07190248?
The trial aims to enroll 675 participants. The trial is currently recruiting and accepting new participants.
How is NCT07190248 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single 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 NCT07190248?
The primary outcome measures are: Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% (Up to approximately 48 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07190248 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Stamford, Connecticut; Miami Beach, Florida; Westbrook, Maine and 16 more sites (United States, Argentina, Australia).
Where can I find official information about NCT07190248?
The official record for NCT07190248 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07190248. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07190248 testing in simple terms?
This study tests a new drug called calderasib combined with an immunotherapy drug (pembrolizumab) against a standard chemotherapy treatment for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and has spread or cannot be removed by surgery.
Why is this trial significant?
This trial addresses a significant unmet need for patients with KRAS G12C-mutant NSCLC, a group with limited effective first-line treatment options, by investigating a novel combination of targeted th 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 NCT07190248?
Common side effects may include fatigue, nausea, diarrhea, rash, and changes in blood counts. Specific risks related to the study drugs include potential for immune system overreaction (with immunotherapy) and effects on the heart or digestive system. There is a risk that the cancer may not respond to the treatment or may become resistant over time. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07190248?
Ask your doctor if your lung cancer has the KRAS G12C mutation and if this trial is a good fit for you. Participation involves regular clinic visits for assessments, receiving study medications, and monitoring for side effects. You will be randomly assigned to one of two treatment groups, and you will know which treatment you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07190248 signal from an investment perspective?
This Phase 3 trial, sponsored by Merck, signals a significant investment in a novel combination therapy for a specific lung cancer subtype, aiming to capture a share of the growing oncology market wit 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 be randomly assigned to receive either the new combination therapy or chemotherapy, and will receive either pills or injections/infusions. 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
More Non-small Cell Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.