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New treatment option for Advanced/Metastatic Non-Small Cell Lung Cancer
Official title A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT07154290
What this study is testing
What is Ubamatamab?
Ubamatamab is an investigational medicine, being studied as a potential treatment for advanced/metastatic non-small cell lung cancer.
Also referred to as REGN4018.
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 will evaluate two study drugs called ubamatamab and REGN7075, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab. The study is looking at: How well ubamatamab and REGN7075 works The side effects that ubamatamab and REGN7075 might cause How much ubamatamab and REGN7075 is in the blood at different times If the body makes antibodies to ubamatamab and/or REGN7075, this may cause the ubamatamab to not work as well
- Phase 2: a mid-size study of how well it works
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
- Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or...
- Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
- If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless...
- Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
- Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target...
You likely can't join if
- Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
- Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing...
- Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as...
- Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive...
- Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
- Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
See the full eligibility criteria
- Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
- Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
- If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate
- Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
- Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is...
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Key
- Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
- Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone...
- Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
- Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of...
- Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
- Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
- Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
- Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol NOTE: Other protocol defined...
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Irvine, California, United States
- Chicago, Illinois, United States
- Munster, Indiana, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Galveston, Texas, United States
- Houston, Texas, United States
- Temple, Texas, United States
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 - 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?
Study sites include Goodyear, Arizona, United States; Irvine, California, United States; Chicago, Illinois, United States; Munster, Indiana, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.