A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
New trial tests advanced lung cancer drug after prior treatment failure
Plain English Summary
Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-small Cell Lung Cancer (NSCLC). This trial tests a new drug combination (sacituzumab tirumotecan) against a standard chemotherapy combination for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has a certain genetic mutation (EGFR) and has not responded to previous targeted therapy. Participation involves receiving either the new drug combination or the standard chemotherapy, with regular check-ups and monitoring. Alternative treatments may include other chemotherapy regimens or participation in different clinical trials, depending on the patient's specific situation. The trial aims to enroll 520 participants.
Official Summary
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with advanced non-squamous non-small cell lung cancer (NSCLC) with an EGFR mutation. Must have had their cancer progress after prior treatment with EGFR tyrosine kinase inhibitors (TKIs). Patients must have a life expectancy of at least 3 months and have recovered from side effects of previous treatments. Patients with predominantly squamous cell lung cancer, active inflammatory bowel disease, uncontrolled heart disease, or active brain metastases are not eligible. This trial is studying Non-small Cell Lung Cancer (NSCLC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The trial will measure how long patients live without their cancer getting worse (progression-free survival) and how long they live overall (overall survival) to see if the new drug is more effective The specific primary outcome measures are: Progression-Free Survival (PFS) (Up to approximately 51 months); Overall Survival (OS) (Up to approximately 51 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 new treatments for patients with EGFR-mutated NSCLC whose cancer has become resistant to existing targeted 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 (NSCLC), where improved treatment options are needed.
Investor Insight
This trial targets a significant unmet need in a large cancer market, with potential for a new treatment option if successful, indicating a positive investment signal. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 520 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of both treatment options being studied. Understand the schedule of visits, tests, and potential side effects associated with each treatment. Be prepared for regular blood tests, scans, and clinic visits throughout the study. 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: 520 participants
Interventions
- BIOLOGICAL: Sacituzumab tirumotecan — 4 mg/kg via IV infusion
- DRUG: Pemetrexed — 500 mg/m\^2 via IV infusion
- DRUG: Carboplatin — AUC 5 mg/mL\*min via IV infusion
- DRUG: H1 Receptor Antagonist — Administered as rescue medication per approved product label
- DRUG: H2 Receptor Antagonist — Administered as rescue medication per approved product label
Primary Outcomes
- Progression-Free Survival (PFS) (Up to approximately 51 months)
- Overall Survival (OS) (Up to approximately 51 months)
Secondary Outcomes
- Objective Response Rate (ORR) (Up to approximately 51 months)
- Duration of Response (DOR) (Up to approximately 51 months)
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score (Baseline and up to approximately 6 years)
- Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 (Baseline and up to approximately 6 years)
- Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13) (Baseline and up to approximately 6 years)
Full Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC). * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. * 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. * Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Life expectancy of at least 3 months. Exclusion Criteria: * Predominantly squamous cell histology NSCLC. * History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * Grade ≥2 peripheral neuropathy. * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing. * Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. * Uncontrolled, or significant cardiovascular disease or cerebrovascular disease. * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Received radiation therapy to the lung that is \>30 Gray within 6 months of the first dose of study intervention. * Known active central nervous system metastases and/or carcinomatous meningitis. * Active infection requiring systemic therapy. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Concurrent active HBV and HCV infection. * History of allogeneic tissue/solid organ transplant. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Trial Locations
- Kaiser Permanente - Oakland ( Site 0054), Oakland, California, United States
- Kaiser Permanente - Roseville ( Site 0055), Roseville, California, United States
- Kaiser Permanente - San Francisco ( Site 0056), San Francisco, California, United States
- Kaiser Permanente - Santa Clara ( Site 0057), Santa Clara, California, United States
- Kaiser Permanente-Kaiser Permanente ( Site 0036), Vallejo, California, United States
- Kaiser Permanente - Walnut Creek ( Site 0058), Walnut Creek, California, United States
- Mid Florida Hematology and Oncology Center ( Site 0005), Orange City, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003), Marietta, Georgia, United States
- University of Michigan ( Site 0009), Ann Arbor, Michigan, United States
- Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051), Springfield, Missouri, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06305754?
NCT06305754 is a Phase 3 INTERVENTIONAL study titled "Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 520 participants.
What conditions does NCT06305754 study?
This trial investigates treatments for Non-small Cell Lung Cancer (NSCLC). The primary condition under study is Non-small Cell Lung Cancer (NSCLC).
What treatments are being tested in NCT06305754?
The interventions being studied include: Sacituzumab tirumotecan (BIOLOGICAL), Pemetrexed (DRUG), Carboplatin (DRUG), H1 Receptor Antagonist (DRUG), H2 Receptor Antagonist (DRUG). 4 mg/kg via IV infusion
What does Phase 3 mean for NCT06305754?
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 NCT06305754?
This trial is currently "Recruiting." It started on 2024-06-11. The estimated completion date is 2030-06-14.
Who is sponsoring NCT06305754?
NCT06305754 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 NCT06305754?
The trial aims to enroll 520 participants. The trial is currently recruiting and accepting new participants.
How is NCT06305754 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 NCT06305754?
The primary outcome measures are: Progression-Free Survival (PFS) (Up to approximately 51 months); Overall Survival (OS) (Up to approximately 51 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06305754 being conducted?
This trial is being conducted at 20 sites, including Oakland, California; Roseville, California; San Francisco, California; Santa Clara, California and 16 more sites (United States, Argentina).
Where can I find official information about NCT06305754?
The official record for NCT06305754 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06305754. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06305754 testing in simple terms?
This trial tests a new drug combination (sacituzumab tirumotecan) against a standard chemotherapy combination for advanced lung cancer. It is for patients with a specific type of non-small cell lung cancer (NSCLC) that has a certain genetic mutation (EGFR) and has not responded to previous targeted therapy.
Why is this trial significant?
This trial addresses a critical need for new treatments for patients with EGFR-mutated NSCLC whose cancer has become resistant to existing targeted 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 NCT06305754?
Common side effects may include nausea, vomiting, diarrhea, fatigue, and low blood cell counts. There is a risk of lung inflammation (pneumonitis) or nerve damage (neuropathy). Specific side effects related to the new drug may include skin rash and mouth sores. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06305754?
Ask your doctor about the specific risks and benefits of both treatment options being studied. Understand the schedule of visits, tests, and potential side effects associated with each treatment. Be prepared for regular blood tests, scans, and clinic visits throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06305754 signal from an investment perspective?
This trial targets a significant unmet need in a large cancer market, with potential for a new treatment option if successful, indicating a positive investment signal. 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 the standard chemotherapy, with regular check-ups and monitoring. 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.