Platinum-doublet chemotherapy / REGN2810 / Advanced Non Small Cell Lung Cancer · Observational Study

Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Participants

ClinicalTrials.gov · September 10, 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 planned observational cohort study registered to evaluate cemiplimab plus platinum-doublet chemotherapy in first-line advanced NSCLC using US electronic health records. No results are currently reported in this registry record; the study is active but not recruiting and measures real-world response rate and immune-mediated adverse events over approximately 3 years.

What was studied

Observational. Advanced Non-small Cell Lung Cancer; age from 18 Years. Intervention: Study Participants. n = 1,000. 1 site: United States.

Key findings

Safety

Observational retrospective design with no randomized comparator; efficacy and safety estimates will lack causal inference

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a planned observational cohort study with no results reported; it describes a real-world registry design but carries no outcome data, efficacy estimates, or safety findings yet.

Study design

As stated by the source record.

MethodsCohort model. Other time perspective. Primary outcome measures: Real-world Response Rate (rwRR) (assessed at Approximately 3 years); Any treatment-emergent immune-mediated Adverse Event (imAE) (assessed at Approximately 3 years); Any treatment-emergent imAE resulting in hospitalization (assessed at Approximately 3 years); Any treatment-emergent imAE resulting in death (assessed at Approximately 3 years); Specific treatment-emergent imAEs (assessed at Approximately 3 years)

DesignObservational

PopulationAdvanced Non-small Cell Lung Cancer; age from 18 Years

Sample size1,000

InterventionStudy Participants

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment1000

Study duration (primary outcome assessment)Approximately 3 years

Primary outcome 1Real-world Response Rate (rwRR)

Primary outcome 2Any treatment-emergent immune-mediated Adverse Event (imAE)

Primary outcome 3Any treatment-emergent imAE resulting in hospitalization

Primary outcome 4Any treatment-emergent imAE resulting in death

Primary outcome 5Specific treatment-emergent imAEs

Caveats

No results are posted in this registry record; study is actively enrolling but not yet complete
Observational retrospective design with no randomized comparator; efficacy and safety estimates will lack causal inference
Real-world response rate is not a validated endpoint; definitions and measurement methods not specified in this record
No effect sizes, confidence intervals, or p-values available; follow-up duration and data quality from EHR sources not detailed

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

Observational retrospective cohort from EHR databases; no randomization or blinding

Directness

strong

Real-world data from US clinical practice; direct measurement of response and adverse events

Consistency

insufficient

Single study; no comparative data or replication mentioned in registry record

Risk of bias

limited

Retrospective, observational design; selection and measurement bias inherent; no control arm

Sample adequacy

strong

Planned enrollment 1000 participants; adequate for real-world cohort description

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 (NCT06269133). This is a study registration, not published results. Lead sponsor: Regeneron Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Advanced Non-small Cell Lung Cancer. Interventions: DRUG: REGN2810; OTHER: Platinum-doublet chemotherapy. Primary outcome measures: Real-world Response Rate (rwRR) , Approximately 3 years; Any treatment-emergent immune-mediated Adverse Event (imAE) , Approximately 3 years; Any treatment-emergent imAE resulting in hospitalization , Approximately 3 years; Any treatment-emergent imAE resulting in death , Approximately 3 years; Specific treatment-emergent imAEs , Approximately 3 years. Brief summary: This multi-year cohort study will assess the real-world safety and effectiveness of first Line (1L) treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC participant subgroups defined by age, sex, race, and ethnicity. Participants will be retrospectively identified from at least two US Electronic Health Record (EHR)-based databases.

Follow from this

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

Platinum-doublet chemotherapyREGN2810Advanced Non Small Cell Lung CancerNCT06269133Regeneron Pharmaceuticals