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Non-small Cell Lung CancerPhase 2/3NCT05800015

A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer

A Phase 2/3 study testing fianlimab, cemiplimab and Pemetrexed in people with Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 76 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
fianlimab, cemiplimab and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
76 sitesin 10 countries
Study dates
8 Aug 2023to 23 Dec 2031
Phase
Phase 2/3
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

Who may be able to join

  • Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC.
  • Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol
  • For enrollment in phase 2, patients should have PD-L1, expression results (regardless of expression level) determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have a valid PD-L1 result, regardless of expression level, using an assay as performed by a central laboratory, as described in the protocol.
  • At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  • Adequate organ and bone marrow function as defined in the protocol.

Who cannot join

  • Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy.
  • Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or ROS oncogene 1 (ROS1) fusions, as described in the protocol.
  • Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
  • History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.
  • Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome, T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
Show all 12Show fewer
  • Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Patients with clinically relevant systemic immune suppression within the last 3 months before trial enrollment are excluded. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
  • Patients who have received prior systemic therapies are excluded with the exception of the following:
  • Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAE grade ≤1 or baseline with the exception of alopecia and peripheral neuropathy.
  • Anti-PD-(L)1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is >12 months prior to enrollment.
  • Prior exposure to other immunomodulatory or vaccine as an adjuvant or neoadjuvant therapy such as Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibodies as long as the last dose is >6 months prior to enrollment. Immune-mediated AEs must be resolved to CTCAE grade ≤1 or baseline by the time of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other non-immunosuppressive therapies without resolution prior to enrollment are allowed.
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

76 sites in 10 countries.

76 sites in 10 countries

United States29 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87102

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • The Oncology Institute of Hope & Innovation

    Cerritos, California, 90703

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • University of Illinois

    Chicago, Illinois, 60612

  • Clermont Oncology Center

    Clermont, Florida, 34711

  • Crosson Cancer Institute

    Fullerton, California, 92835

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Thompson Cancer Survival Center (TCSC ) - Downtown

    Knoxville, Tennessee, 37916

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Miami Veterans Administration HealthCare System

    Miami, Florida, 33125

  • Bon Secours Cancer Institute Richmond

    Midlothian, Virginia, 23114

  • Yale Cancer Center

    New Haven, Connecticut, 06519

  • NYU Langone Health Perlmutter Cancer Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • St. Joseph Hospital Orange

    Orange, California, 92868

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

  • Capital Health Hopewell Medical Center

    Pennington, New Jersey, 08534

  • Desert Hematology Oncology Medical Group Incorporated

    Rancho Mirage, California, 92270

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373

  • Northwest Oncology and Hematology

    Rolling Meadows, Illinois, 60008

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

  • PIH Health Hospital

    Whittier, California, 90602

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Georgia10 sites

  • LLC High-Tech Hospital Medcenter

    Batumi, Adjara, 6000

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • Research Institute of Clinical Medicine

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

  • High Technology Medical Center, University Clinic Tbilisi

    Tbilisi, 0144

  • LTD Archangel St. Michael Multiprofile Clinical Hospital

    Tbilisi, 0159

  • NNLE New Vision University Hospital

    Tbilisi, 0159

  • The Institute of Clinical Oncology

    Tbilisi, 0159

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160

  • JSC Evex Hospitals - Caraps Medline

    Tbilisi, 0179

Other trials in Georgia

South Korea10 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Chungnam National University Hospital

    Daejeon, 35015

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565

  • Inha University Hospital

    Incheon, 22332

  • CHA Bundang Medical Center CHA University

    Seongnam-si, Gyeonggi-do, 13520

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

  • St. Vincents Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Taiwan8 sites

  • Dalin Tzu Chi Hospital

    Dalin Town, Chiayi, 622

  • Buddhist Tzu Chi General Hospital

    Hualien City, Hualien, 970

  • Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561

  • National Cheng Kung University Hospital

    Tainan, 701

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110301

  • Tri-Service General Hospital

    Taipei, 114202

Other trials in Taiwan

Malaysia7 sites

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

  • Hospital Tengku Ampuan Afzan (HTTA)

    Kuantan, Pahang, 25100

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • National Cancer Institute

    Putrajaya, Putrajaya, 62250

  • Mount Miriam Cancer Hospital

    Tanjung Bungah, Pulau Pinang, 11200

Other trials in Malaysia

Australia6 sites

  • Ballarat Regional Integrated Cancer Centre (BRICC)

    Ballarat, Victoria, 3350

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Macquarie University Health Science Center (MQ Health)

    Macquarie Park, New South Wales, 2113

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada2 sites

  • British Columbia Cancer Center-Kelowna

    Kelowna, British Columbia, V1Y 5L3

  • Hopital Cite de la Sante

    Laval, Quebec, H7M 3L9

Other trials in Canada

Israel2 sites

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Assuta Medical Centers

    Tel Aviv, 6971028

Other trials in Israel

Thailand1 site

  • Lampang Cancer Center

    Lampang, Changwat Lampang, 52000

Other trials in Thailand

Turkey (Türkiye)1 site

  • Adana City Education and Research Hospital

    Adana, Yuregir, 1060

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a "study drug" or collectively called "study drugs". 'Investigational' means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC).

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, in comparison with cemiplimab and chemotherapy.

Read more

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs
  • How much of each study drug is in your blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
  • How administering the study drugs might improve your quality of life
Read the detailed description

Phase 3 was not initiated and no participants were enrolled.

Being tested
fianlimab, cemiplimab, Pemetrexed, Paclitaxel, Carboplatin
Keywords
NSCLC, Lung cancer, Programmed cell death ligand-1, PD-L1, Lymphocyte-activation gene 3, LAG-3, African descent
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fianlimabDrug

    Also called REGN3767

    Administered intravenously (IV) every 3 weeks (Q3W)

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Administered IV Q3W

  • PemetrexedDrug

    Also called Alimta

    IV Infusion, Q3W

  • PaclitaxelDrug

    IV Infusion, Q3W

  • CarboplatinDrug

    Also called Paraplatin

    IV Infusion, Q3W

  • CisplatinDrug

    Also called Platinol

    IV infusion, Q3W

  • PlaceboDrug

    IV infusion, Q3W

Study groups in NCT05800015
Study groupRoleWhat they receive
Phase 2 - Arm AExperimentalRandomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy
Receives: Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin
Phase 2 - Arm BExperimentalRandomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy
Receives: Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin
Phase 2 - Arm CExperimentalRandomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Receives: Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo
Phase 3 - Arm A or BExperimentalRandomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy
Receives: Drug: fianlimab; Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin
Phase 3 - Arm CExperimentalRandomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Receives: Drug: cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1

    Phase 2 ORR is defined as proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR).

    Measured: Up to 136 Weeks

  2. Overall Survival (OS)

    Phase 3 Defined as the time from randomization to the date of death due to any cause

    Measured: Up to 5 years

Secondary outcomes (39)

  1. Incidence of treatment-emergent adverse event (TEAEs)

    Phase 2 \& Phase 3 A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment

    Measured: Up to 108 weeks

  2. Incidence of treatment-related TEAEs

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  3. Incidence of serious adverse events (SAEs)

    Phase 2 \& Phase 3

    Any untoward medical occurrence that at any dose:

    • Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
    • Is life-threatening
    • Requires in-patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Is an important medical event

    Measured: Up to 108 weeks

  4. Incidence of adverse events of special interest (AESIs)

    Phase 2 \& Phase 3 Serious or non-serious; is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it.

    Measured: Up to 108 weeks

  5. Incidence of immune-mediated adverse events (imAEs)

    Phase 2 \& Phase 3 Immune-mediated AEs are thought to be caused by unrestrained cellular immune responses directed at normal host tissues. An imAE can occur shortly after the first dose or several months after the last dose of treatment. Early detection and management reduces the risk of severe drug induced toxicity

    Measured: Up to 108 weeks

  6. Occurrence of interruption of study drug(s) due to AEs

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  7. Occurrence of discontinuation of study drug(s) due to AEs

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  8. Incidence of deaths due to TEAE

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  9. Incidence of grade 3-4 laboratory abnormalities

    Phase 2 \& Phase 3

    ≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE v5.0]

    Measured: Up to 108 weeks

  10. ORR by investigator assessment using RECIST 1.1

    Phase 2 \& Phase 3

    Measured: Up to 136 Weeks

  11. Disease control rate (DCR) by BICR

    Phase 2 and Phase 3 DCR is defined as CR + PR + stable disease (SD)

    Measured: Up to 136 Weeks

  12. DCR by investigator assessment

    Phase 2 and Phase 3 DCR is defined as CR + PR + stable disease (SD)

    Measured: Up to 136 Weeks

  13. Time to tumor response (TTR) by BICR

    Phase 2 and Phase 3 TTR is defined as the time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR.

    Measured: Up to 136 Weeks

  14. TTR by investigator assessment

    Phase 2 and Phase 3 TTR is defined as the time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR

    Measured: Up to 136 Weeks

  15. Duration of response (DOR) by BICR

    Phase 2 and Phase 3 DOR is defined as the time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

    Measured: Up to 5 Years

  16. DOR by investigator assessment

    Phase 2 and Phase 3 DOR is defined as the time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

    Measured: Up to 5 Years

  17. Progression free survival (PFS) by BICR

    Phase 2 and Phase 3 PFS is defined as the time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

    Measured: Up to 5 Years

  18. PFS by investigator assessment

    Phase 2 and Phase 3 PFS is defined as the time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

    Measured: Up to 5 Years

  19. OS

    Phase 2 Defined as the time from randomization to the date of death due to any cause

    Measured: Up to 5 Years

  20. Change from baseline in patient-reported global health status/quality of life (GHS/QoL) per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Phase 2 \& Phase 3 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a GHS/QoL scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

    Measured: Up to 108 weeks

  21. Change from baseline in physical functioning per EORTC QLQ-C30

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  22. Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    Phase 2 \& Phase 3 EORTC QLQ-LC 13 is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients

    Measured: Up to 108 weeks

  23. Change from baseline in patient-reported dyspnea per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  24. Change from baseline in patient-reported cough per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  25. Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  26. Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  27. Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  28. Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  29. Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  30. Time until definitive deterioration in a composite of these three symptoms: patient-reported chest pain, dyspnea and cough per EORTC QLQ-LC13

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  31. Change from baseline in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) VAS

    Phase 2 \& Phase 3 The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine".

    Measured: Up to 108 weeks

  32. Change from baseline in patient-reported severity with usual or daily activities due to fatigue per the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Phase 2 \& Phase 3 PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.

    Measured: Up to 108 weeks

  33. Change from baseline in patient-reported interference with usual or daily activities due to fatigue per the PRO-CTCAE

    Phase 2 \& Phase 3

    Measured: Up to 108 weeks

  34. Concentrations of cemiplimab in serum

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

  35. Concentrations of fianlimab in serum

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

  36. Immunogenicity, as measured by anti-drug antibodies (ADA) to fianlimab

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

  37. Immunogenicity, as measured by ADA to cemiplimab

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

  38. Immunogenicity, as measured by neutralizing antibodies (NAb) to fianlimab

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

  39. Immunogenicity, as measured by NAb to cemiplimab

    Phase 2 \& Phase 3

    Measured: Up to 136 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start8 Aug 2023
  3. Primary completion16 Jan 2030 (estimated)
  4. Study completion23 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800015
Sponsor's protocol ID
R3767-ONC-2236
Other IDs
2022-501577-40-00
Status last verified
Jul 2026
First submitted
23 Mar 2023
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fianlimab, cemiplimab and Pemetrexed in people with Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 76 sites in 10 countries.

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 6 inclusion and 12 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Georgia, South Korea, Taiwan, Malaysia and 5 more countries. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Objective response rate (ORR) as assessed by blinded independent review committee (BICR) using RECIST 1.1 (time frame: Up to 136 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800015.

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 15 Jul 2026.

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