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Double immune punch: new combo trial for tough lung cancer

NCT ID NCT05785767

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests whether adding fianlimab to the standard immunotherapy cemiplimab helps people with advanced non-small cell lung cancer that has high levels of a protein called PD-L1. About 850 patients will receive either the drug combo or cemiplimab alone. Researchers will measure tumor shrinkage and overall survival, while also tracking side effects and quality of 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 and cemiplimab (two immune-boosting drugs given together)
What this could lead to
If successful, this combination could offer a more effective first-line treatment for advanced non-small cell lung cancer, potentially improving survival and tumor shrinkage compared to current standard therapy.
What could go wrong
This is an early-to-mid-stage trial, and the combination may not prove more effective than cemiplimab alone. Immune-related side effects could be more frequent or severe with two drugs.

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

149 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Sep 2027

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 levels ≥ 50%, as 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 4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (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 described in the protocol. Key Exclusion Criteria: 1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime. 2. 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. 3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions, as described in the protocol. 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment. 5. 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. 6. 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). 7. 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. 8. 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. 9. 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 therapies as an adjuvant or neoadjuvant therapy, 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.

non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced non-small cell lung cancer

Contacts and locations

Locations

  • Acibadem Adana Hastanesi

    Adana, Adana, 1330, Turkey (Türkiye)

  • Adana City Education and Research Hospital

    Adana, Yuregir, 1060, Turkey (Türkiye)

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Ankara Etlik Sehir Hastanesi Ankara Etlik City Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Ankara Yildirim Beyazit Universitesi - Tip Fakultesi

    Ankara, 06050, Turkey (Türkiye)

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715, United States

  • Assuta Medical Centers

    Tel Aviv, 6971028, Israel

  • Ballarat Regional Integrated Cancer Centre (BRICC)

    Ballarat, Victoria, 3350, Australia

  • Baskent University

    Adana, 1123, Turkey (Türkiye)

  • Bendigo Hospital

    Bendigo, Victoria, 3550, Australia

  • Bezmialem Vakif University

    Istanbul, 34093, Turkey (Türkiye)

  • 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

  • Bursa Uludag University Medical Faculty

    Bursa, Gorukle Bursa Turkiye, 16059, Turkey (Türkiye)

  • Cancer Center of Adjara

    Batumi, Adjara, 6000, Georgia

  • Chiang Mai University

    Chiang Mai, 50200, Thailand

  • 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

  • Dalin Tzu Chi Hospital

    Dalin, Chia-Yi, 622, Taiwan

  • Eastern CT Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Ege University Faculty of Medicine

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373, United States

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718, United States

  • Gachon University Gil Medical Center

    Incheon, Gyeonggi-do, 21565, South Korea

  • Gazi University

    Ankara, 06100, Turkey (Türkiye)

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe University Medical Faculty

    Altındağ, Ankara, 06230, Turkey (Türkiye)

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401, United States

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706, Spain

  • Hospital De Valme

    Seville, 41001, Spain

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Hospital Pulau Pinang

    Pulau Pinang, 10990, Malaysia

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100, Malaysia

  • Hospital Tengku Ampuan Afzan (HTTA)

    Kuantan, Pahang, 25100, Malaysia

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

    Barcelona, Catalonia, 08028, Spain

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450, Turkey (Türkiye)

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450, Turkey (Türkiye)

  • Istinye University VMMedical Park Pendik Hospital

    Pendik, Istanbul, 34899, Turkey (Türkiye)

  • Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Ve Arastirma Hastanesi

    Izmir, 35110, Turkey (Türkiye)

  • Izmir Economy University Medical Point Hospital

    Izmir, 35325, Turkey (Türkiye)

  • JSC Evex Hospitals - Caraps Medline

    Tbilisi, 0179, Georgia

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Koc University

    Istanbul, 34010, Turkey (Türkiye)

  • Kocaeli University Hospital

    Kocaeli, Marmara, 41380, Turkey (Türkiye)

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Lampang Cancer Center

    Lampang, Changwat Lampang, 52000, Thailand

  • Liv Hospital Ankara

    Ankara, 06100, Turkey (Türkiye)

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • 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

  • Medipol University Hospital

    Istanbul, Bagcilar, 34284, Turkey (Türkiye)

  • Memorial Ankara Hospital

    Ankara, 906520, Turkey (Türkiye)

  • Memorial Bahcelievler Hospital

    Istanbul, 34180, Turkey (Türkiye)

  • Mercy South

    St Louis, Missouri, 63128, United States

  • Miami Veterans Administration HealthCare System

    Miami, Florida, 33125, United States

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NNLE New Vision University Hospital

    Tbilisi, 0159, Georgia

  • National Cancer Institute

    Putrajaya, Putrajaya, 62250, Malaysia

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Navamindradhiraj University

    Dusit, Bangkok, 10300, Thailand

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Meram, 42080, Turkey (Türkiye)

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87102, United States

  • Ondokuz Mayıs University

    Kurupelit, Samsun, 55139, Turkey (Türkiye)

  • Pinellas Hematology and Oncology

    St. Petersburg, Florida, 33709, United States

  • Prince Of Songkla Hospital, Prince Of Songkhla University

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Renovatio Clinical

    El Paso, Texas, 79915, United States

  • Research Institute of Clinical Medicine

    Tbilisi, 0112, Georgia

  • Riverina Cancer Care Centre (RCCC)

    Wagga Wagga, New South Wales, 2650, Australia

  • Sakarya University

    Sakarya, Serdivan, 54050, Turkey (Türkiye)

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100, Turkey (Türkiye)

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Soroka University Medical Center

    Beersheba, Southern District, 84101, Israel

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500, Australia

  • St. Vincent Healthcare

    Billings, Montana, 59102, 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

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 0144, Georgia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Institute of Clinical Oncology

    Tbilisi, 0159, Georgia

  • Trakya University

    Edirne, 22030, Turkey (Türkiye)

  • Tri-Service General Hospital

    Taipei, 114, 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

  • Vall d'Hebron Barcelona Hospital Campus

    Barcelona, 08035, Spain

  • Vm Medicalpark Hospital

    Samsun, 55200, Turkey (Türkiye)

  • Yuksek Ihtisas Unıversity Medicalpark Hospital

    Ankara, 06370, Turkey (Türkiye)

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364, United States

More trials for these conditions

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