Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Phase 3 trial tests new lung cancer treatment combination
Plain English Summary
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] 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 drugs, including pembrolizumab and sacituzumab tirumotecan, to see if it's more effective than current treatments for advanced squamous non-small cell lung cancer. It is for adults diagnosed with metastatic squamous non-small cell lung cancer who have not received prior treatment for their advanced disease. Participants will receive initial treatment with pembrolizumab plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel), followed by either pembrolizumab alone or pembrolizumab plus sacituzumab tirumotecan. Standard chemotherapy with or without immunotherapy is the current typical treatment for this condition. The trial aims to enroll 851 participants.
Official Summary
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have been diagnosed with squamous non-small cell lung cancer that has spread to other parts of the body (Stage IV). You must have measurable disease and a life expectancy of at least 3 months. You cannot join if you have small cell lung cancer, certain eye or bowel conditions, significant heart or brain disease, or have had specific prior cancer treatments like certain immunotherapies or targeted drugs for advanced lung cancer. Participants must be between 18 and 80 years old and have good general health, with specific criteria for conditions like HIV, Hepatitis B, or Hepatitis C. 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 main goal is to see if the new drug combination helps patients live longer overall, which means it could offer a better chance of extending life for those with this disease. The specific primary outcome measures are: Overall survival (OS) (Up to ~50 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 a specific type of advanced lung cancer by investigating a novel drug combination that targets cancer in new ways. 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 first-line treatment for metastatic squamous NSCLC, a large market where improved survival outcomes are highly sought after, suggesting a potentially hig Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 851 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific drugs being tested, how often you'll need to visit the clinic, and what side effects are possible. Participation involves regular clinic visits for drug infusions, blood tests, scans to check your cancer, and answering questionnaires about your health and quality of life. You will receive initial chemotherapy and immunotherapy, followed by a second phase of treatment which may include an additional drug, sacituzumab tirumotecan. 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: NONE
- Enrollment: 851 participants
Interventions
- BIOLOGICAL: Pembrolizumab — Intravenous (IV) infusion
- BIOLOGICAL: sac-TMT — IV infusion
- DRUG: Carboplatin — Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
- DRUG: Paclitaxel — Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.
- DRUG: Nab-paclitaxel — Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.
Primary Outcomes
- Overall survival (OS) (Up to ~50 months)
Secondary Outcomes
- Progression-Free Survival (PFS) (Up to ~79 months)
- Number of Participants With ≥1 Adverse Event (AE) (Up to ~79 months)
- Number of Participants Discontinuing from Study Therapy Due to AE(s) (Up to ~79 months)
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30) (Baseline and up to ~79 months)
- Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8) (Baseline and up to ~79 months)
Full Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\] * Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology * Has life expectancy ≥3 months * Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral 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 before allocation * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible) * Has adequate organ function * For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization * For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit * For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered Exclusion Criteria: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention * HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC * Received prior therapy with an anti-programmed cell death 1 protein (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 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC) * Received radiation therapy to the lung that is \>30 Gray 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 * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Received prior treatment with a topoisomerase I inhibitor-containing ADC * Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks) * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known central nervous system (CNS) metastases/carcinomatous meningitis * Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy * Acti
Trial Locations
- CARTI Cancer Center ( Site 0006), Little Rock, Arkansas, United States
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122), Burbank, California, United States
- Exempla Lutheran Medical Center ( Site 0119), Golden, Colorado, United States
- Intermountain Health St. Mary's Regional Hospital ( Site 0116), Grand Junction, Colorado, United States
- Mid Florida Hematology and Oncology Center ( Site 0109), Orange City, Florida, United States
- Centricity Research Columbus Cancer Center ( Site 0111), Columbus, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001), Marietta, Georgia, United States
- Southeastern Regional Medical Center ( Site 0004), Newnan, Georgia, United States
- University of Chicago Medical Center ( Site 0145), Chicago, Illinois, United States
- Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146), Minneapolis, Minnesota, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06422143?
NCT06422143 is a Phase 3 INTERVENTIONAL study titled "Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 851 participants.
What conditions does NCT06422143 study?
This trial investigates treatments for Non-small Cell Lung Cancer, NSCLC. The primary condition under study is Non-small Cell Lung Cancer.
What treatments are being tested in NCT06422143?
The interventions being studied include: Pembrolizumab (BIOLOGICAL), sac-TMT (BIOLOGICAL), Carboplatin (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG). Intravenous (IV) infusion
What does Phase 3 mean for NCT06422143?
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 NCT06422143?
This trial is currently "Recruiting." It started on 2024-06-10. The estimated completion date is 2031-02-12.
Who is sponsoring NCT06422143?
NCT06422143 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 NCT06422143?
The trial aims to enroll 851 participants. The trial is currently recruiting and accepting new participants.
How is NCT06422143 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06422143?
The primary outcome measures are: Overall survival (OS) (Up to ~50 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06422143 being conducted?
This trial is being conducted at 20 sites, including Little Rock, Arkansas; Burbank, California; Golden, Colorado; Grand Junction, Colorado and 16 more sites (United States, Argentina).
Where can I find official information about NCT06422143?
The official record for NCT06422143 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06422143. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06422143 testing in simple terms?
This trial is testing a new combination of drugs, including pembrolizumab and sacituzumab tirumotecan, to see if it's more effective than current treatments for advanced squamous non-small cell lung cancer. It is for adults diagnosed with metastatic squamous non-small cell lung cancer who have not received prior treatment for their advanced disease.
Why is this trial significant?
This trial aims to improve survival for patients with a specific type of advanced lung cancer by investigating a novel drug combination that targets cancer in new ways. 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 NCT06422143?
Common side effects may include fatigue, nausea, hair loss, and changes in blood cell counts. More serious risks can include allergic reactions to the drugs, lung inflammation, kidney problems, and skin reactions. Specific to sacituzumab tirumotecan, potential side effects include diarrhea, low white blood cell counts, and mouth sores. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06422143?
Ask your doctor about the specific drugs being tested, how often you'll need to visit the clinic, and what side effects are possible. Participation involves regular clinic visits for drug infusions, blood tests, scans to check your cancer, and answering questionnaires about your health and quality of life. You will receive initial chemotherapy and immunotherapy, followed by a second phase of treatment which may include an additional drug, sacituzumab tirumotecan. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06422143 signal from an investment perspective?
This trial targets a significant unmet need in first-line treatment for metastatic squamous NSCLC, a large market where improved survival outcomes are highly sought after, suggesting a potentially hig 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 initial treatment with pembrolizumab plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel), followed by either pembrolizumab alone or pembrolizumab plus sacituzumab tirumotecan. 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.