Ubamatamab and Marlotamig for Advanced Non-Small Cell Lung Cancer
A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Recruiting
Phase 2Interventional Study
Non Small Cell Lung CancerAdvanced Non Small Cell Lung CancerMetastatic Non Small Cell Lung CancerCarcinoma Non Small Cell Lung
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Regeneron Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with advanced or metastatic Non-Small Cell Lung Cancer. Participants will receive treatments and undergo various tests to see how well they work and what side effects may occur.
Are You a Good Fit for This Trial?
Rules you outActive brain metastasesTreatment-related unresolved toxicity
You may be able to join if
I have been diagnosed with advanced or metastatic Non-Small Cell Lung Cancer.
I have received standard first line treatment for my cancer.
I have available tumor tissue for testing.
I have at least one measurable lesion shown on imaging.
I have an ECOG performance status of 0 or 1.
You may not be able to join if
My cancer has progressed within the last 84 days after starting initial anti-PD-(L)1 therapy.
I have unresolved side effects from previous treatments.
I have an untreated primary brain tumor or active brain metastases.
I am currently in or was in another study with an investigational treatment in the last 4 weeks.
I received an anti-PD-(L)1 monoclonal antibody in the last 21 days.
I had another anti-cancer immunotherapy in the last 21 days.
I received cytotoxic chemotherapy in the last 21 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
* H…
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
Trial Locations
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Status
Eligibility Criteria
Key Inclusion Criteria:
1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, a…
Key Inclusion Criteria:
1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
3. 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
4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
5. 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 documented (radiographic) disease progression in that site
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key Exclusion Criteria:
1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
2. 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)
3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
4. 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
5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
8. 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 inclusion / exclusion criteria apply
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