A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study will evaluate two study drugs called ubamatamab and marlotamig, 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 marlotamig work(s) * The side effects that ubamatamab and marlotamig might cause * How much ubamatamab and marlotamig is in the blood at different times * If the body makes antibodies to ubamatamab and/or marlotamig, this may cause the ubamatamab to not work as well

Eligibility criteria

Qualifiers

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

Disqualifiers

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 replacement therapy)

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 study intervention in this clinical study

Trial design

Treatments tested in this trial

  • Ubamatamab
  • Marlotamig
  • Sarilumab

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators