Metastatic Non Small Cell Lung Cancer / Advanced Non Small Cell Lung Cancer / Sarilumab · Phase 2 Trial

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

ClinicalTrials.gov · August 13, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 trial registration for ubamatamab with and without marlotamig in advanced/metastatic NSCLC, with sarilumab as an adjunctive agent to manage immune-related adverse effects. No results are currently reported in this registry record; the study is actively recruiting and will measure objective response by RECIST v1.1 over up to 5 years of follow-up.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung; age from 18 Years. Intervention: Arm 1A; Arm 1B; Arm 1C; Arm 2A; Arm 2B; Arm 2C. n = 300. 15 sites: United States.

Key findings

Safety

This is a registry record with no posted results; no efficacy, safety, or immunogenicity data are reported

Who this may help

This trial will provide Phase 2 evidence on novel immunotherapy combinations (ubamatamab and marlotamig) in advanced NSCLC; results are not yet available and must be awaited before any clinical application can be considered. The inclusion of sarilumab to manage immune-related adverse effects reflects emerging focus on toxicity mitigation in combination immunotherapy.

Plain-language summary

This is a Phase 2 trial registration with no results reported; it describes a planned study of experimental agents in advanced NSCLC with surrogate endpoints (objective response by RECIST), requiring completion and results publication before evidence strength can be assessed.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed at Up to 5 years)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNon-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung; age from 18 Years

Sample size300

InterventionArm 1A; Arm 1B; Arm 1C; Arm 2A; Arm 2B; Arm 2C

Setting15 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment300

PhasePhase 2

Primary outcome measureObjective response as assessed by investigator per RECIST v1.1, up to 5 years

Recruitment statusRECRUITING

Clinical bottom line

Caveats

This is a registry record with no posted results; no efficacy, safety, or immunogenicity data are reported
Detailed study design elements (randomization method, blinding, arm assignments, control comparators) are not specified in this registry summary
Follow-up duration extends to 5 years but interim data timing and final analysis plan are not described
Primary endpoint is objective response (surrogate), not overall survival or durable benefit; clinical significance of response will depend on magnitude and durability when results are reported

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with planned enrollment and defined primary endpoint

Directness

moderate

Studies advanced/metastatic NSCLC directly; primary endpoint is objective response by RECIST v1.1

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone

Risk of bias

insufficient

Study design details insufficient; blinding, comparator arms, and analysis plan not fully specified

Sample adequacy

moderate

Estimated enrollment 300 participants; adequate for Phase 2 but not yet enrolled

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07154290). This is a study registration, not published results. Lead sponsor: Regeneron Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung. Interventions: DRUG: Ubamatamab; DRUG: Marlotamig; DRUG: Sarilumab. Primary outcome measures: Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 , Up to 5 years. Brief summary: 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07154290Metastatic Non Small Cell Lung CancerAdvanced Non Small Cell Lung CancerSarilumabMarlotamigUbamatamabRegeneron PharmaceuticalsNon Small Cell Lung Cancer