An observational study in Non-small Cell Lung Cancer, sponsored by Regeneron Pharmaceuticals. Active, not recruiting at 46 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Regeneron Pharmaceuticals · Observational
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Among 21 studies in Carcinoma, Non-Small-Cell Lung by Regeneron Pharmaceuticals — 2 open to participants now, 11 under way, 2 of them phase 3. Carcinoma, Non-Small-Cell Lung · Regeneron Pharmaceuticals.
Among the 21 studies in Carcinoma, Non-Small-Cell Lung by Regeneron Pharmaceuticals, this one is the only one that started in 2022, is one of 2 observational ones, reaches primary completion later than 6 of the 10 other live ones, and was the 12th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →2 of the 21 studies in Carcinoma, Non-Small-Cell Lung by Regeneron Pharmaceuticals are open now, in 1 country. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18+
Regeneron Pharmaceuticals
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 12 · Phase 3 5
First in 2008; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 509 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 86 across the 18 interventional studies, 755 across the 2 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
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Regeneron Pharmaceuticals is the lead sponsor of 412 studies on the registry; 90 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
3 of the studies in Carcinoma, Non-Small-Cell Lung by Regeneron Pharmaceuticals that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05785767Phase 3Regeneron PharmaceuticalsA Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | 2027-09-28 |
| NCT06269133Regeneron PharmaceuticalsEvaluation 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 | 2027-03-31 |
| NCT04077099Regeneron PharmaceuticalsA Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer | 2027-07-06 |
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Among the 21 studies in Carcinoma, Non-Small-Cell Lung by Regeneron Pharmaceuticals, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.
The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.
The recruitment period will be 48 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.
The source population for this study will be patients with either locally advanced NSCLC not suitable for definitive chemoradiation or metastatic NSCLC and who are initiating a cemiplimab-based regimen of treatment as part of routine clinical practice at the time of study enrollment. The study will aim to enroll approximately 500 adult patients from up to 50 sites across Europe.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cemiplimab monotherapy
Drug: Cemiplimab
Cemiplimab in combination with platinum-based chemotherapy
Drug: Cemiplimab · Drug: Platinum-based chemotherapy
solution for injection via intravenous (IV) infusion
Also known as: SAR439684- Libtayo
IV administration
Overall survival (OS)
Date and primary cause of death
Time frame: Up to 72 months
Overall Response Rate (ORR)
Defined as the proportion of patients with a complete response or partial as the physician-reported best overall response.
Time frame: Up to 72 months
Duration of Response (DoR)
Defined among responders (patients with a complete response or partial response) as the time from the date of the first response after cemiplimab treatment initiation until the first date of disease progression or death due to any cause.
Time frame: Up to 72 months
Time to Response (TTR)
Defined as the time from the first cemiplimab dose until the date of first response observed for that patient. Patients who die during the study will be censored using the date of the last valid disease assessment).
Time frame: Up to 72 months
Progression-Free Survival (PFS)
Defined as the time from the first dose of cemiplimab until the date of the first documented tumour progression or death due to any cause.
Time frame: Up to 72 months
Time to first subsequent anti-NSCLC treatment (TTST)
Defined as the time from the first cemiplimab dose until the date of the first subsequent anti-NSCLC treatment.
Time frame: Up to 72 months
Incidence of treatment-related adverse events (TR-AEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Number of patients with treatment related adverse events occurring during treatment
Time frame: Up to 72 months
Incidence of treatment-related serious adverse events (TR-SAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Number of patients with serious treatment related adverse events occurring during treatment
Time frame: Up to 72 months
Incidence and severity of immune-mediated adverse events (imAEs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Number of patients with immune-mediated adverse events and serious immune-mediated adverse events occurring during treatment
Time frame: Up to 72 months
Incidence and severity of infusion related reactions (IRRs) in patients with advanced NSCLC treated with a cemiplimab-based regimen in routine clinical practice
Number of patients with infusion related reactions and serious infusion related reactions adverse events occurring during treatment
Time frame: Up to 72 months
Started Oct 2022 (actual). Primary completion is estimated for Oct 2028, 71 months after the start.
Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's planned 71 months is above that.
Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →