Trial comparing treatments for Non-small Cell Lung Cancer (NSCLC)
Official title 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)
ClinicalTrials.gov ID: NCT06170788
What this study is testing
What is Sacituzumab tirumotecan?
An investigational IV infusion being studied as a possible treatment for non‑small cell lung cancer. It is designed to bind the Trop‑2 protein on cancer cells and deliver a chemotherapy payload that interferes with DNA replication.
Also referred to as SKB264, MK-2870.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding sacituzumab tirumotecan (a drug) to pembrolizumab (an immunotherapy) helps people with metastatic non‑small cell lung cancer live longer.
- Who it's for
- You may be able to join if you have metastatic non‑small cell lung cancer and a PD‑L1 tumor score of 50% or higher.
- What's involved
- You would receive either the drug combo sacituzumab tirumotecan and pembrolizumab, or pembrolizumab alone, given by infusion at the clinic. You will have regular check‑ups and tests to see how you are doing.
- Time commitment
- The study runs until enough time passes to compare survival, with clinic visits for treatment and follow‑up every few weeks.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an...
- 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.
You likely can't join if
- 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...
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's...
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
- Received prior systemic anticancer therapy for their metastatic NSCLC.
See the full eligibility 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)
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Burbank, California, United States
- Grand Junction, Colorado, United States
- Jacksonville, Florida, United States
- Westbrook, Maine, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Hattiesburg, Mississippi, United States
- Reno, Nevada, United States
- Corvallis, Oregon, United States
- Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Buenos Aires, Buenos Aires F.D., Argentina
- Río Cuarto, Córdoba Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Port Macquarie, New South Wales, Australia
- Westmead, New South Wales, Australia
- Epping, Victoria, Australia
- Frankston, Victoria, Australia
- Porto Alegre, Rio Grande do Sul, Brazil
+ 120 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Burbank, California, United States; Grand Junction, Colorado, United States; Jacksonville, Florida, United States; Westbrook, Maine, United States; Minneapolis, Minnesota, United States and 134 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.