A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)
New Lung Cancer Trial Tests Combination Therapy for Advanced Disease
Plain English Summary
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Non-small Cell Lung Cancer (NSCLC). This trial is testing a new combination of two drugs, sacituzumab tirumotecan and pembrolizumab, against pembrolizumab alone. It is for patients with non-small cell lung cancer that has spread and whose tumors have a specific marker (PD-L1 TPS ≥ 50%). Participants will receive one of the two treatment regimens randomly, and may involve regular clinic visits for infusions and monitoring. Standard treatment options for this condition include chemotherapy and immunotherapy, depending on specific tumor characteristics and prior treatments. The trial aims to enroll 614 participants.
Official Summary
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer that has spread to other parts of the body. Tumors must show high levels of PD-L1 (50% or more). Patients must have an ECOG performance status of 0 or 1 (able to carry out all self-care to fully active, capable of all pre-disease performance status but without capacity for strenuous jobs or physical labor). Patients cannot have received prior treatment for their metastatic lung cancer, nor prior immunotherapy targeting PD-1/PD-L1 (unless for early-stage disease completed at least 12 months prior). 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 primary goal is to see if the new drug combination helps patients live longer overall compared to pembrolizumab alone. The specific primary outcome measures are: Overall Survival (OS) (Up to approximately 49 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 improve survival for patients with advanced non-small cell lung cancer by investigating a novel combination therapy that may be more effective than current standard treatments. 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 specific subset of lung cancer patients, potentially offering a new treatment option in a competitive immunotherapy market, with a high PD-L1 expression suggesting a higher likeli Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 614 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for your specific type of lung cancer and if you meet all the requirements. Participation involves receiving either the combination therapy or pembrolizumab alone, which are given through IV infusions, and attending regular appointments for monitoring and tests. Be prepared for potential side effects and discuss any new or worsening symptoms with your healthcare team promptly. 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: 614 participants
Interventions
- BIOLOGICAL: Sacituzumab tirumotecan — IV infusion
- BIOLOGICAL: Pembrolizumab — IV infusion
- DRUG: Supportive care measures — Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions
Primary Outcomes
- Overall Survival (OS) (Up to approximately 49 months)
Secondary Outcomes
- Progression free survival (PFS) (Up to approximately 49 months)
- Objective Response (OR) (Up to approximately 49 months)
- Duration of Response (DOR) (Up to approximately 49 months)
- Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score (Baseline and up to approximately 77 months)
- Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score (Baseline and up to approximately 77 months)
Full Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC * Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy * Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization. * A life expectancy of at least 3 months. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Has 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. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention. * Received prior systemic anticancer therapy for their metastatic NSCLC. * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. * Received radiation therapy to the lung that is \>30 Gy within 6 months of start of study intervention. * 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 are allowed. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary. * Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy. * Active autoimmune disease that has required systemic treatment in the past 2 years. * History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. * Active infection requiring systemic therapy * Concurrent active Hepatitis B and Hepatitis C virus infection. * Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * History of allogeneic tissue/solid organ transplant. * Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
Trial Locations
- Mayo Clinic in Arizona - Phoenix ( Site 0147), Phoenix, Arizona, United States
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130), Burbank, California, United States
- Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132), Grand Junction, Colorado, United States
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133), Jacksonville, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106), Marietta, Georgia, United States
- The University of Louisville, James Graham Brown Cancer Center ( Site 0121), Louisville, Kentucky, United States
- New England Cancer Specialists ( Site 0143), Westbrook, Maine, United States
- University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144), Worcester, Massachusetts, United States
- Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115), Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester ( Site 0148), Rochester, Minnesota, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06170788?
NCT06170788 is a Phase 3 INTERVENTIONAL study titled "Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 614 participants.
What conditions does NCT06170788 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 NCT06170788?
The interventions being studied include: Sacituzumab tirumotecan (BIOLOGICAL), Pembrolizumab (BIOLOGICAL), Supportive care measures (DRUG). IV infusion
What does Phase 3 mean for NCT06170788?
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 NCT06170788?
This trial is currently "Recruiting." It started on 2023-12-15. The estimated completion date is 2030-05-27.
Who is sponsoring NCT06170788?
NCT06170788 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 NCT06170788?
The trial aims to enroll 614 participants. The trial is currently recruiting and accepting new participants.
How is NCT06170788 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 NCT06170788?
The primary outcome measures are: Overall Survival (OS) (Up to approximately 49 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06170788 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Burbank, California; Grand Junction, Colorado; Jacksonville, Florida and 16 more sites (United States, Argentina).
Where can I find official information about NCT06170788?
The official record for NCT06170788 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06170788. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06170788 testing in simple terms?
This trial is testing a new combination of two drugs, sacituzumab tirumotecan and pembrolizumab, against pembrolizumab alone. It is for patients with non-small cell lung cancer that has spread and whose tumors have a specific marker (PD-L1 TPS ≥ 50%).
Why is this trial significant?
This trial aims to improve survival for patients with advanced non-small cell lung cancer by investigating a novel combination therapy that may be more effective than current standard treatments. 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 NCT06170788?
Common side effects may include fatigue, nausea, diarrhea, and low blood cell counts. More serious risks can involve lung inflammation, liver problems, and severe allergic reactions. Peripheral neuropathy (nerve damage causing tingling or numbness) is a potential concern, and pre-existing or severe cases may exclude you. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06170788?
Ask your doctor if this trial is a good fit for your specific type of lung cancer and if you meet all the requirements. Participation involves receiving either the combination therapy or pembrolizumab alone, which are given through IV infusions, and attending regular appointments for monitoring and tests. Be prepared for potential side effects and discuss any new or worsening symptoms with your healthcare team promptly. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06170788 signal from an investment perspective?
This trial targets a specific subset of lung cancer patients, potentially offering a new treatment option in a competitive immunotherapy market, with a high PD-L1 expression suggesting a higher likeli 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 one of the two treatment regimens randomly, and may involve regular clinic visits for infusions 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
More Non-small Cell Lung Cancer (NSCLC) Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.