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New triple therapy aims to boost lung cancer survival

NCT ID NCT05800015

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study tests whether adding fianlimab to standard immunotherapy (cemiplimab) and chemotherapy improves outcomes for people with advanced non-small cell lung cancer. About 950 participants will receive either the triple combination or the double combination. The goal is to see if the new drug helps shrink tumors and extend life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fianlimab, cemiplimab, and chemotherapy (pemetrexed, paclitaxel, carboplatin, or cisplatin)
What this could lead to
If successful, this combination could offer a new first-line treatment option for advanced lung cancer, potentially improving response rates and survival.
What could go wrong
This is an early-to-mid stage trial; the added drug may increase side effects without clear benefit. Results may not apply to all lung cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

160 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. 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. 2. 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 3. 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. 4. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. 6. Adequate organ and bone marrow function as defined in the protocol. Key Exclusion Criteria: 1. 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. 2. 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. 3. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment. 4. 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. 5. 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). 6. 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. 7. 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. 8. Patients who have received prior systemic therapies are excluded with the exception of the following: 1. 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. 2. 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. 3. 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

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Adana City Education and Research Hospital

    Adana, Yuregir, 1060, Turkey (Türkiye)

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Assuta Medical Centers

    Tel Aviv, 6971028, Israel

  • Ballarat Regional Integrated Cancer Centre (BRICC)

    Ballarat, Victoria, 3350, Australia

  • Bendigo Hospital

    Bendigo, Victoria, 3550, Australia

  • Bon Secours Cancer Institute Richmond

    Midlothian, Virginia, 23114, United States

  • British Columbia Cancer Center-Kelowna

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Buddhist Tzu Chi General Hospital

    Hualien City, Hualien, 970, Taiwan

  • CHA Bundang Medical Center CHA University

    Seongnam-si, Gyeonggi-do, 13520, South Korea

  • Capital Health Hopewell Medical Center

    Pennington, New Jersey, 08534, United States

  • Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • Clermont Oncology Center

    Clermont, Florida, 34711, United States

  • Clinical Research Alliance Inc

    Westbury, New York, 11590, United States

  • Crosson Cancer Institute

    Fullerton, California, 92835, United States

  • Dalin Tzu Chi Hospital

    Dalin Town, Chiayi, 622, Taiwan

  • Desert Hematology Oncology Medical Group Incorporated

    Rancho Mirage, California, 92270, United States

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373, United States

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565, South Korea

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401, United States

  • High Technology Medical Center, University Clinic Tbilisi

    Tbilisi, 0144, Georgia

  • Hopital Cite de la Sante

    Laval, Quebec, H7M 3L9, Canada

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang

    Pulau Pinang, 10990, Malaysia

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100, Malaysia

  • Hospital Tengku Ampuan Afzan (HTTA)

    Kuantan, Pahang, 25100, Malaysia

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Inha University Hospital

    Incheon, 22332, South Korea

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • JSC Evex Hospitals - Caraps Medline

    Tbilisi, 0179, Georgia

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • LLC High-Tech Hospital Medcenter

    Batumi, Adjara, 6000, Georgia

  • LTD Archangel St. Michael Multiprofile Clinical Hospital

    Tbilisi, 0159, Georgia

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • Lampang Cancer Center

    Lampang, Changwat Lampang, 52000, Thailand

  • Macquarie University Health Science Center (MQ Health)

    Macquarie Park, New South Wales, 2113, Australia

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809, United States

  • Miami Veterans Administration HealthCare System

    Miami, Florida, 33125, United States

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Mount Miriam Cancer Hospital

    Tanjung Bungah, Pulau Pinang, 11200, Malaysia

  • NNLE New Vision University Hospital

    Tbilisi, 0159, Georgia

  • NYU Langone Health Perlmutter Cancer Center

    New York, New York, 10016, United States

  • National Cancer Institute

    Putrajaya, Putrajaya, 62250, Malaysia

  • National Cheng Kung University Hospital

    Tainan, 701, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87102, United States

  • Northwest Oncology and Hematology

    Rolling Meadows, Illinois, 60008, United States

  • PIH Health Hospital

    Whittier, California, 90602, United States

  • Research Institute of Clinical Medicine

    Tbilisi, 0112, Georgia

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045, United States

  • Sarawak General Hospital

    Kuching, Sarawak, 93586, Malaysia

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601, Israel

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500, Australia

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150, Australia

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • St. Joseph Hospital Orange

    Orange, California, 92868, United States

  • St. Vincents Hospital - The Catholic University of Korea

    Suwon, Gyeonggi-do, 16247, South Korea

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160, Georgia

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taipei Medical University Hospital

    Taipei, 110301, Taiwan

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308, United States

  • The Institute of Clinical Oncology

    Tbilisi, 0159, Georgia

  • The Oncology Institute of Hope & Innovation

    Cerritos, California, 90703, United States

  • Thompson Cancer Survival Center (TCSC ) - Downtown

    Knoxville, Tennessee, 37916, United States

  • Tri-Service General Hospital

    Taipei, 114202, Taiwan

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06519, United States

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.