Advanced Non-small Cell Lung CancerNCT06269133
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
An observational study of Advanced Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- REGN2810 and Platinum-doublet chemotherapy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced disease, defined as stage IIIB, IIIC, or IV disease, with evidence of administration of 1L cemiplimab in combination with platinum-doublet chemotherapy between 08 Nov 2022 and 30 Jun 2026 and without EGFR, ALK, or ROS1 genomic variants, or actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy.
Who may be able to join
- 1. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol
Who cannot join
- Participants who have EGFR, ALK or ROS1 variants
- Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date
- Participants actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Regeneron Research Facility
Tarrytown, New York, 10591
About this study
Official title: Evaluating the Safety and Effectiveness of Cemiplimab in Combination With Platinum-Doublet Chemotherapy by Demographic Characteristics in First-Line Treatment of Advanced Non-Small Cell Lung Cancer: A Multi-Database Real World Evidence Study in US Patients
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.
Read the detailed description
Participants and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- REGN2810, Platinum-doublet chemotherapy
- Keywords
- Advanced Non-Small Cell Lung Cancer (aNSCLC), Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), C-ros oncogene receptor tyrosine kinase (ROS1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN2810Drug
Also called LIBTAYO®, cemiplimab
No study specific interventions for this non-interventional-observational study; participants had previously been administered this treatment.
Platinum-doublet chemotherapyOther
No study specific interventions for this non-interventional-observational study; participants had previously been administered this treatment.
| Study group | Role | What they receive |
|---|---|---|
| Study Participants | Participants who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol. Receives: Drug: REGN2810; Other: Platinum-doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Response Rate (rwRR)
Measured: Approximately 3 years
Any treatment-emergent immune-mediated Adverse Event (imAE)
Measured: Approximately 3 years
Any treatment-emergent imAE resulting in hospitalization
Measured: Approximately 3 years
Any treatment-emergent imAE resulting in death
Measured: Approximately 3 years
Specific treatment-emergent imAEs
Measured: Approximately 3 years
Secondary outcomes (7)
Real-world Duration Of Response (rwDOR)
Measured: Approximately 3 years
Real-world Progression-Free survival (rwPFS)
Measured: Approximately 3 years
Real-world Overall Survival (rwOS)
Measured: Approximately 3 years
imAEs
Measured: Approximately 3 years
Infusion-Related Reaction (IRR)
Measured: Approximately 3 years
IRR resulting in hospitalization
Measured: Approximately 3 years
IRR resulting in death
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start21 Feb 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269133
- Sponsor's protocol ID
- R2810-ONC-22115
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Effectiveness of Cemiplimab in Combination With Platinum-Doublet Chemotherapy by Demographic Characteristics in First-Line Treatment of Advanced Non-Small Cell Lung Cancer: A Multi-Database Real World Evidence Study in US Patients
- ClinicalTrials.gov ID
- NCT06269133
- Acronym / sponsor ID
- R2810-ONC-22115
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- Advanced Non-Small Cell Lung Cancer (aNSCLC), Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), C-ros oncogene receptor tyrosine kinase (ROS1)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Participants | – | Drug: REGN2810, Other: Platinum-doublet chemotherapyParticipants who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced disease, defined as stage IIIB, IIIC, or IV disease, with evidence of administration of 1L cemiplimab in combination with platinum-doublet chemotherapy between 08 Nov 2022 and 30 Jun 2026 and without EGFR, ALK, or ROS1 genomic variants, or actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy.
Key inclusion criteria (1 listed)
- 1. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol
Key exclusion criteria (4 listed)
- Participants who have EGFR, ALK or ROS1 variants
- Treatment with EGFR, ALK or ROS1 inhibitors at any time prior to the index date
- Participants actively enrolled in a clinical trial in which they receive treatment with cemiplimab in combination with platinum-doublet chemotherapy
- Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN2810Also: LIBTAYO®, cemiplimabNo study specific interventions for this non-interventional-observational study; participants had previously been administered this treatment. | Drug | Study Participants |
| Platinum-doublet chemotherapyNo study specific interventions for this non-interventional-observational study; participants had previously been administered this treatment. | Other | Study Participants |
Primary outcome
Real-world Response Rate (rwRR)
Time frame: Approximately 3 years
Any treatment-emergent immune-mediated Adverse Event (imAE)
Time frame: Approximately 3 years
Any treatment-emergent imAE resulting in hospitalization
Time frame: Approximately 3 years
Any treatment-emergent imAE resulting in death
Time frame: Approximately 3 years
Specific treatment-emergent imAEs
Time frame: Approximately 3 years
7 secondary outcomes
Real-world Duration Of Response (rwDOR)
Time frame: Approximately 3 years
Real-world Progression-Free survival (rwPFS)
Time frame: Approximately 3 years
Real-world Overall Survival (rwOS)
Time frame: Approximately 3 years
imAEs
Time frame: Approximately 3 years
Infusion-Related Reaction (IRR)
Time frame: Approximately 3 years
IRR resulting in hospitalization
Time frame: Approximately 3 years
IRR resulting in death
Time frame: Approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Response Rate (rwRR) (time frame: Approximately 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.