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Advanced Non-Small Cell Lung CancerPhase 2/3NCT05785767

A 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)

A Phase 2/3 study testing fianlimab and cemiplimab in people with Advanced Non-Small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 106 sites in 11 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 experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). 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?
fianlimab and cemiplimab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
106 sitesin 11 countries
Study dates
30 Jun 2023to 28 Sep 2027
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 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
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  • Adequate organ and bone marrow function, as described in the protocol.

Who cannot join

  • Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
  • 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 c-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).
Show all 13Show fewer
  • 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.
  • 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 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.

Trial locations and contacts

106 sites in 11 countries.

106 sites in 11 countries

Turkey (Türkiye)30 sites

  • Acibadem Adana Hastanesi

    Adana, Adana, 1330

  • Adana City Education and Research Hospital

    Adana, Yuregir, 1060

  • Baskent University

    Adana, 1123

  • Hacettepe University Medical Faculty

    Altındağ, Ankara, 06230

  • Ankara Etlik Sehir Hastanesi Ankara Etlik City Hospital

    Ankara, 06010

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Ankara Yildirim Beyazit Universitesi - Tip Fakultesi

    Ankara, 06050

  • Gazi University

    Ankara, 06100

  • Liv Hospital Ankara

    Ankara, 06100

  • Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam

    Ankara, 06100

  • Yuksek Ihtisas Unıversity Medicalpark Hospital

    Ankara, 06370

  • Memorial Ankara Hospital

    Ankara, 906520

  • Ege University Faculty of Medicine

    Bornova, İzmir, 35100

  • Bursa Uludag University Medical Faculty

    Bursa, Gorukle Bursa Turkiye, 16059

  • Trakya University

    Edirne, 22030

  • Gaziantep Medicalpoint Hospital

    Gaziantep, Sehitkamil, 27584

  • Medipol University Hospital

    Istanbul, Bagcilar, 34284

  • Koc University

    Istanbul, 34010

  • Bezmialem Vakif University

    Istanbul, 34093

  • Memorial Bahcelievler Hospital

    Istanbul, 34180

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450

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

    Izmir, 35110

  • Izmir Economy University Medical Point Hospital

    Izmir, 35325

  • Kocaeli University Hospital

    Kocaeli, Marmara, 41380

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Meram, 42080

  • Ondokuz Mayıs University

    Kurupelit, Samsun, 55139

  • Istinye University VMMedical Park Pendik Hospital

    Pendik, Istanbul, 34899

  • Sakarya University

    Sakarya, Serdivan, 54050

  • Vm Medicalpark Hospital

    Samsun, 55200

Other trials in Turkey (Türkiye)

United States23 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87102

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • St. Vincent Healthcare

    Billings, Montana, 59102

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • University of Illinois

    Chicago, Illinois, 60612

  • Clermont Oncology Center

    Clermont, Florida, 34711

  • Renovatio Clinical

    El Paso, Texas, 79915

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Miami Veterans Administration HealthCare System

    Miami, Florida, 33125

  • Bon Secours Cancer Institute Richmond

    Midlothian, Virginia, 23114

  • Eastern CT Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

  • Emad Ibrahim, MD, Inc.

    Redlands, California, 92373

  • Mercy South

    St Louis, Missouri, 63128

  • Pinellas Hematology and Oncology

    St. Petersburg, Florida, 33709

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Clinical Research Alliance Inc

    Westbury, New York, 11590

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Spain9 sites

  • Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location

    Barcelona, Catalonia, 08028

  • Vall d'Hebron Barcelona Hospital Campus

    Barcelona, 08035

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Son Espases

    Palma, Balearic Islands, 07120

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

  • Hospital De Valme

    Seville, 41001

Other trials in Spain

Georgia8 sites

  • Cancer Center of Adjara

    Batumi, Adjara, 6000

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • Research Institute of Clinical Medicine

    Tbilisi, 0112

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

    Tbilisi, 0144

  • 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

Taiwan8 sites

  • Dalin Tzu Chi Hospital

    Dalin, Chia-Yi, 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, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110301

  • Tri-Service General Hospital

    Taipei, 114

Other trials in Taiwan

South Korea7 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Chungnam National University Hospital

    Daejeon, 35015

  • Gachon University Gil Medical Center

    Incheon, Gyeonggi-do, 21565

  • 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

Thailand6 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Navamindradhiraj University

    Dusit, Bangkok, 10300

  • Prince Of Songkla Hospital, Prince Of Songkhla University

    Hat Yai, Changwat Songkhla, 90110

  • Lampang Cancer Center

    Lampang, Changwat Lampang, 52000

Other trials in Thailand

Australia5 sites

  • Ballarat Regional Integrated Cancer Centre (BRICC)

    Ballarat, Victoria, 3350

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • Macquarie University Health Science Center (MQ Health)

    Macquarie Park, New South Wales, 2113

  • Riverina Cancer Care Centre (RCCC)

    Wagga Wagga, New South Wales, 2650

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Malaysia5 sites

  • Hospital Sultan Ismail

    Johor Bahru, Johor, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

  • Hospital Tengku Ampuan Afzan (HTTA)

    Kuantan, Pahang, 25100

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • National Cancer Institute

    Putrajaya, Putrajaya, 62250

Other trials in Malaysia

Israel4 sites

  • Soroka University Medical Center

    Beersheba, Southern District, 84101

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Assuta Medical Centers

    Tel Aviv, 6971028

Other trials in Israel

Canada1 site

  • British Columbia Cancer Center-Kelowna

    Kelowna, British Columbia, V1Y 5L3

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

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

Read more

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

  • What side effects may happen from taking the study drugs
  • How much 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, Placebo
Keywords
Treatment naïve, NSCLC

What participants receive

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

  • fianlimabDrug

    Also called REGN3767

    Administered per the protocol

  • cemiplimabDrug

    Also called REGN2810, Libtayo

    Administered per the protocol

  • PlaceboDrug

    Administered per the protocol

Study groups in NCT05785767
Study groupRoleWhat they receive
A: fianlimab+cemiplimabExperimentalPhase 2: fianlimab (HD)
Receives: Drug: fianlimab; Drug: cemiplimab
B: fianlimab+cemiplimabExperimentalPhase 2: fianlimab (LD)
Receives: Drug: fianlimab; Drug: cemiplimab
C: cemiplimab monotherapy+placeboExperimentalPhase 2
Receives: Drug: cemiplimab; 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 central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

    Measured: Up to 136 weeks

Secondary outcomes (43)

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

    Measured: Up to 136 weeks

  2. Incidence of treatment-related TEAEs

    Measured: Up to 136 weeks

  3. Incidence of serious adverse events (SAEs)

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

  8. Occurrence of interruption of study drug(s) due to AESIs

    Measured: Up to 136 weeks

  9. Occurrence of discontinuation of study drug(s) due to AESIs

    Measured: Up to 136 weeks

  10. Occurrence of interruption of study drug(s) due to imAEs

    Measured: Up to 136 weeks

  11. Occurrence of discontinuation of study drug(s) due to imAEs

    Measured: Up to 136 weeks

  12. Incidence of deaths due to TEAE

    Measured: Up to 136 weeks

  13. Incidence of grade 3 to 4 laboratory abnormalities

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

    Measured: Up to 136 weeks

  14. ORR by investigator assessment, using RECIST 1.1

    Measured: Up to 136 weeks

  15. Disease control rate (DCR) by BICR

    Measured: Up to 136 weeks

  16. DCR by investigator assessment

    Measured: Up to 136 weeks

  17. Time to tumor response (TTR) by BICR

    Measured: Up to 136 weeks

  18. TTR by investigator assessment

    Measured: Up to 136 weeks

  19. Duration of response (DOR) by BICR

    Measured: Up to 5 years

  20. DOR by investigator assessment

    Measured: Up to 5 years

  21. Progression free survival (PFS) by BICR

    Measured: Up to 5 years

  22. PFS by investigator assessment

    Measured: Up to 5 years

  23. Overall survival (OS)

    Measured: Up to 5 years

  24. 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 Core Questionnaire (EORTC QLQ-C30)

    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 5 years

  25. Change from baseline in patient-reported physical functioning per EORTC QLQ-C30

    Measured: Up to 5 years

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

    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 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

  34. Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13

    Measured: Up to 5 years

  35. Change from baseline in patient-reported general health status per EuroQoL-5 Dimensions, 5-level Questionnaire-Visual Analogue Score (EQ-5D-5L VAS)

    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 5 years

  36. 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).

    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 5 years

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

    Measured: Up to 5 years

  38. Concentrations of cemiplimab in serum

    Measured: Up to 136 weeks

  39. Concentrations of fianlimab in serum

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

  41. Immunogenicity, as measured by ADA to cemiplimab

    Measured: Up to 136 weeks

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

    Measured: Up to 136 weeks

  43. Immunogenicity, as measured by NAb to cemiplimab

    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 posted27 Mar 2023
  2. Study start30 Jun 2023
  3. Primary completion28 Sep 2027 (estimated)
  4. Study completion28 Sep 2027 (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
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785767
Sponsor's protocol ID
R3767-ONC-2235
Other IDs
2022-501483-18-00
Status last verified
Jun 2026
First submitted
14 Mar 2023
Last updated
2 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 and cemiplimab in people with Advanced Non-Small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 106 sites in 11 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 13 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 2 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 106 sites in Turkey (Türkiye), United States, Spain, Georgia, Taiwan and 6 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 central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (time frame: Up to 136 weeks). 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 NCT05785767.

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 2 Jul 2026.

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