A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ubamatamab alone or with marlotamig in adults with advanced non-small cell lung cancer (NSCLC) or NSCLC that has spread. It looks at how well the drugs work and their side effects. It also tests whether sarilumab can help with side effects caused by the immune system’s response to ubamatamab.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have NSCLC confirmed by tissue or cell tests: stage IIIB that cannot be treated with combined chemotherapy and radiation meant to control it, stage IIIC, or stage IV.
- Have received the recommended first treatment for advanced NSCLC or NSCLC that has spread.
- Have received two-drug chemotherapy that includes platinum, unless there is a documented reason it is not right for you.
- Have a stored or new tumor sample available to test for a protein called MUC16.
- Have at least one tumor that can be measured on a CT or MRI scan. A tumor treated with radiation must have grown since that treatment.
- Be fully active or able to do light work, even if hard physical activity is limited.
Who can't join
- Your cancer got worse less than 84 days after you started your first PD-1 or PD-L1 treatment, drugs that help the immune system fight cancer.
- Side effects from earlier treatment are still more than mild. Exceptions include hair loss, hearing loss, moderate nerve damage, or hormone problems treated with replacement hormones.
- Have an untreated or active brain tumor, cancer spread to the brain or spinal cord or their lining, or pressure on the spinal cord, as defined by the study rules.
- Are taking part in another experimental treatment study, or received an experimental treatment in another study within 4 weeks before the planned first study dose.
- Received a PD-1 or PD-L1 antibody drug within 21 days before the first study dose.
- Received another cancer treatment that uses the immune system within 21 days before study treatment.
- Received chemotherapy that kills cancer cells within 21 days before the first study dose.
- Received an antibody drug targeting EGFR too recently before the first study dose. The required waiting time depends on the drug.
Simplified for readability. The official criteria below are what the study team uses.
Official 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, 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
Study sites (17)
AL
- University of Alabama at Birmingham · Birmingham, AL 35233More trials in Birmingham
AZ
- Cancer Treatment Centers of America, Phoenix · Goodyear, AZ 85338More trials in Goodyear
CA
- The City of Hope Orange County Lennar Foundation Cancer Center · Irvine, CA 92618More trials in Irvine
DC
- Georgetown University · Washington D.C., DC 20007More trials in Washington D.C.
DE
- ChristianaCare Health System · Newark, DE 19713More trials in Newark
FL
- Mayo Clinic Jacksonville · Jacksonville, FL 32224More trials in Jacksonville
IL
- Rush University Medical Center · Chicago, IL 60612More trials in Chicago
- University of Illinois Chicago · Chicago, IL 60612More trials in Chicago
IN
- Franciscan Health · Munster, IN 46321More trials in Munster
MD
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, MD 21201More trials in Baltimore
MN
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- Washington University School of Medicine · St Louis, MO 63110More trials in St Louis
TN
- University of Tennessee Medical Center · Knoxville, TN 37920More trials in Knoxville
- Sarah Cannon Research Institute · Nashville, TN 37203More trials in Nashville
TX
- University of Texas Medical Branch · Galveston, TX 77555More trials in Galveston
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- Baylor Scott & White Health · Temple, TX 76508More trials in Temple