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AzTrials

Resectable Non-small Cell Lung CancerPhase 2NCT06161441

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

A Phase 2 study testing Fianlimab, Cemiplimab and Pemetrexed in people with Resectable Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 123 sites in 12 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) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resectable 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
195 participants
Where
123 sitesin 12 countries
Study dates
16 Jul 2024to 4 Nov 2029
Phase
Phase 2
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 newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
  • For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
  • All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
  • A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, hepatic and kidney function as defined in the protocol

Who cannot join

  • Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
  • Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
  • Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
  • Patients with a history of myocarditis
  • Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

123 sites in 12 countries.

123 sites in 12 countries

Italy21 sites

  • Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

    Alessandria, Piedmont, 15121

  • Centro di Riferimento Oncologico (CRO) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

    Aviano, Pordenone, 33081

  • Istituto Tumori Giovanni Paolo II (Istituto di Ricovero e Cura a Carattere Scientifico Bari)

    Bari, 70124

  • ASST Ospedale Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • FPO- IRCCS, Istituto di Candiolo

    Candiolo, Turin, 10060

  • ASST Cremona

    Cremona, 26100

  • Azienda Ospedaliero-Universitaria Ferrara (AOU Ferrara)

    Ferrara, Emilia-Romagna, 44124

  • Careggi University Hospital

    Florence, Firenze, 50134

  • UOC Oncologia Medica Ospedale Civile di Livorno Azienda Usl Toscana Nord Ovest

    Livorno, Livorno, 57124

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milano, 20122

  • Niguarda Cancer Center

    Milan, 20162

  • Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) Pascale

    Naples, Campania, 80131

  • UOC Oncoematologia AOU Vanvitelli

    Naples, Campania, 80131

  • Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology

    Novara, 28100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Azienda Sanitaria Territoriale di Pesaro e Urbino

    Pesaro, Pesaro And Urbino, 61121

  • AUSL Piacenza

    Piacenza, Emilia-Romagna, 29121

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56124

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Instituto Fisioterapici Ospitalieri (IFO) Istituto Regina Elena

    Rome, 00144

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

Spain19 sites

  • IOB Institute of Oncology Quiron

    Barcelona, Catalonia, 08023

  • Instituto Oncologico Dr Rosell

    Barcelona, Catalonia, 08028

  • Althaia - Xarxa Assistencial Universitaria de Manresa - Orde Hospitalaria de Sant Joan de Deu

    Barcelona, 8243

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Universitario Elche

    Elche, Alicante, 3203

  • Catalan Institute of Oncology

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18015

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Fundacion Jimenez Diaz

    Madrid, 28020

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Son Espases

    Palma, Balearic Islands, 07120

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

  • Hospital De Valme

    Seville, 41001

  • Fundacion IVO

    Valencia, 46009

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

  • Alvaro Cunqueiro Hospital

    Vigo, Pontevedra, 36312

Other trials in Spain

Turkey (Türkiye)19 sites

  • Acibadem Adana Hastanesi

    Adana, Adana, 1330

  • Baskent University Adana Turgut Noyan Hospital

    Adana, Yuregir, 01230

  • Adana City Education and Research Hospital

    Adana, Yuregir, 1060

  • Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, Yenimahalle, 06200

  • Gulhane Training and Research Hospital

    Ankara, 06010

  • Liv Hospital Ankara

    Ankara, 06100

  • Hacettepe University Cancer Institute

    Ankara, 06230

  • Memorial Ankara Hospital

    Ankara, 0906520

  • Ankara University Faculty of Medicine

    Ankara, 6620

  • Ege University Faculty of Medicine

    Bornova, İzmir, 35100

  • Medical Point Gaziantep Hastanesi

    Gaziantep, Sehitkamil, 27584

  • Koc University

    Istanbul, 34010

  • Bezmialem Vakif University

    Istanbul, 34093

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital

    Istanbul, 34870

  • Kocaeli University Hospital

    Kocaeli, Marmara, 41380

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Meram, 42080

  • Ondokuz Mayıs University

    Kurupelit, Samsun, 55139

  • Faculty of Medicine of Sakarya University

    Sakarya, Marmara, 54290

Other trials in Turkey (Türkiye)

France10 sites

  • Centre Hospitalier Universitaire (CHU) Bordeaux

    Bordeaux, New Aquitaine, 33076

  • APHP - Hopital Ambroise Pare

    Boulogne-Billancourt, 92100

  • Chi Creteil

    Créteil, Île-de-France Region, 94010

  • CHU Dijon

    Dijon, 21000

  • CHU Limoges

    Limoges, New Aquitaine, 87042

  • Centre de Oncologie de Gentilly

    Nancy, Grand Est, 54000

  • Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec

    Nantes, 44093

  • Hopital Cochin

    Paris, Île-de-France Region, 75014

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, Nantes, 44805

  • Uneos - Hopital R Schuman

    Vantoux, 57070

Other trials in France

Georgia9 sites

  • Cancer Center of Adjara

    Batumi, 6000

  • Israeli Georgian Medical Research Clinic Helsicore

    Tbilisi, 0112

  • Llc Todua Clinic

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

  • High Technology Medical Center, University Clinic Tbilisi

    Tbilisi, 0144

  • Institute of Clinical Oncology

    Tbilisi, 0159

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159

  • TIM - Tbilisi Institute of Medicine

    Tbilisi, 0160

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

South Korea9 sites

  • National Cancer Center

    Gyeonggi-do, Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Gachon University Gil Medical Center

    Incheon, Namdong-Gu, 21565

  • Inha University Hospital

    Incheon, 22332

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 8308

  • The Catholic University of Korea St Vincents Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Taiwan9 sites

  • Changhua Christian Hospital

    Changhua, Changhua County, 50006

  • Hualien Tzu Chi Hospital

    Hualien City, 97002

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Sanmin, 807

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University

    Taichung, 40201

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Medical University Hospital

    Taipei, 110301

  • Tri-Service General Hospital

    Taipei, 114202

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116

Other trials in Taiwan

United States8 sites

  • University of Illinois

    Chicago, Illinois, 60612

  • Clermont Oncology Center

    Clermont, Florida, 34711

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Virginia Cancer Care Specialist, PC

    Fairfax, Virginia, 22031

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • University of Rochester

    Rochester, New York, 14642

  • Mercy South

    St Louis, Missouri, 63128

  • University of Kansas Cancer Center-Westwood

    Westwood, Kansas, 66205

Other trials in United States

Germany8 sites

  • Evang. Kliniken Essen-Mitte

    Essen, North Rhine-Westphalia, 45136

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Universitatsklinium Giesse

    Giessen, 35392

  • LungenClinic

    Großhansdorf, Schleswig-Holstein, 22927

  • Asklepios Klinikum Harburg

    Hamburg, 21075

  • Lungenklinik Hemer

    Hemer, 58675

  • LKI LUngenfachklinik Immenhausen

    Immenhausen, Hesse, 34376

  • MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH

    Neuss, 41462

Other trials in Germany

Chile4 sites

  • Centro de Oncologia de Precision

    Las Condes, Region Metropolitana, Santiago, 7560908

  • Orlandi Oncologia

    Providencia, Metropolitan Region, 7500713

  • Clinica Santa Maria

    Santiago, Providencia, 7520378

  • Oncocentro APYS

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Malaysia4 sites

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Kuala Lumpur

    Kuala Lumpur, Kuala Lumpur, 50586

  • University of Malaya Medical Centre

    Kuala Lumpur, Negeri / Wilayah Persekutuan, 50603

  • Hospital Umum Sarawak

    Kuching, 93586

Other trials in Malaysia

Australia3 sites

  • Eastern Health

    Box Hill, Victoria, 3128

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • St John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

Other trials in Australia

About this study

Official title: A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.

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 the blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
  • How administering the study drugs might affect quality of life
Being tested
Fianlimab, Cemiplimab, Pemetrexed, Paclitaxel, Carboplatin
Keywords
Stage II to IIIB (N2), NSCLC, Neoadjuvant therapy, Subsequent adjuvant therapy, PeriOperative

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

    Administered IV Q3W

  • PaclitaxelDrug

    Also called Taxol

    Administered IV Q3W

  • CarboplatinDrug

    Also called Paraplatin

    Administered IV Q3W

  • CisplatinDrug

    Also called Platinol

    Administered IV Q3W

  • PlaceboDrug

    Administered IV Q3W

Study groups in NCT06161441
Study groupRoleWhat they receive
Arm AExperimentalRandomized 1:1:1 Neoadjuvant period: placebo + cemiplimab + platinum doublet chemotherapy Adjuvant period: placebo + cemiplimab
Receives: Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Placebo
Arm BExperimentalRandomized 1:1:1 Neoadjuvant period: fianlimab high dose + cemiplimab + platinum doublet chemotherapy Adjuvant period: fianlimab high dose + cemiplimab
Receives: Drug: Fianlimab; Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin
Arm CExperimentalRandomized 1:1:1 Neoadjuvant period: fianlimab low dose + cemiplimab + platinum doublet chemotherapy Adjuvant Period: fianlimab low dose + cemiplimab
Receives: Drug: Fianlimab; Drug: Cemiplimab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin

What is being measured

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

  1. Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples

    Measured: Up to 24 months

Secondary outcomes (44)

  1. Event-Free Survival (EFS)

    Measured: Up to 3 years

  2. Major pathological response (MPR) by BIPR in post-treatment resected tumor samples

    Measured: Up to 24 months

  3. MPR by local pathology review in post-treatment resected tumor samples

    Measured: Up to 24 months

  4. Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

    Measured: Up to 24 months

  5. Occurrence of Adverse events (AEs)

    Measured: Up to 5 years

  6. Occurrence of Treatment-emergent adverse event (TEAEs)

    Measured: Up to 5 years

  7. Occurrence of Serious adverse events (SAEs)

    Measured: Up to 5 years

  8. Occurrence of Adverse events of special interest (AESIs)

    Measured: Up to 5 years

  9. Occurrence of immune-mediated adverse events (imAEs)

    Measured: Up to 5 years

  10. Occurrence of interruption and discontinuation of study drug(s) due to TEAE

    Measured: Up to 5 years

  11. Occurrence of laboratory abnormalities

    Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests

    Measured: Up to 5 years

  12. Occurrence of death due to TEAE

    Measured: Up to 5 years

  13. Concentrations of cemiplimab in serum

    Measured: Up to 30 months

  14. Concentrations of fianlimab in serum

    Measured: Up to 30 months

  15. Anti-drug antibodies (ADA) to fianlimab in serum over time

    Measured: Up to 30 months

  16. ADA to cemiplimab in serum over time

    Measured: Up to 30 months

  17. Percentage of patients with definitive surgery

    Measured: Up to 24 months

  18. Percentage of patients with cancelled surgery

    Measured: Up to 24 months

  19. Percentage of patients with delayed surgery

    Measured: Up to 24 months

  20. Completeness of resection (R0, R1, R2, Rx)

    Measured: Up to 24 months

  21. Length in delay of surgery

    Measured: Up to 24 months

  22. Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)

    Measured: Up to 24 months

  23. Median length of hospital stay

    Measured: Up to 24 months

  24. Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)

    Measured: Up to 24 months

  25. Incidence of peri operative AE associated with surgery

    Measured: Up to 90 days post-surgery

  26. Incidence of peri operative SAE associated with surgery

    Measured: Up to 90 days post-surgery

  27. Incidence of post operative AE associated with surgery

    Measured: Up to 90 days post-surgery

  28. Incidence of post operative SAE associated with surgery

    Measured: Up to 90 days post-surgery

  29. Overall change in patient-reported global health status/QoL per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (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

  30. Overall change in patient-reported physical functioning per EORTC QLQ-C30

    Measured: Up to 5 years

  31. Overall change in patient-reported role functioning per EORTC QLQ-C30

    Measured: Up to 5 years

  32. Overall change in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.

    Measured: Up to 5 years

  33. Overall change in patient-reported dyspnea per EORTC QLQ-LC13

    Measured: Up to 5 years

  34. Overall change in patient-reported cough per EORTC QLQ-LC13

    Measured: Up to 5 years

  35. Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13

    Measured: Up to 5 years

  36. Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index

    The EQ-5D-5L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: no problems, slight problems, moderate problems, severe problems and extreme problems

    Measured: Up to 5 years

  37. Change in patient-reported general health status per Visual analogue scale (VAS) scores

    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

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

  40. Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

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

    Measured: Up to 5 years

Timeline

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

  1. First posted7 Dec 2023
  2. Study start16 Jul 2024
  3. Primary completion24 Aug 2026 (estimated)
  4. Study completion4 Nov 2029 (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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06161441
Sponsor's protocol ID
R3767-ONC-2266
Other IDs
2023-505172-29-00, 2023
Status last verified
Aug 2026
First submitted
29 Nov 2023
Last updated
10 Aug 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 study testing Fianlimab, Cemiplimab and Pemetrexed in people with Resectable Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 123 sites in 12 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 6 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in Italy, Spain, Turkey (Türkiye), France, Georgia and 7 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 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.

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?

Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples (time frame: Up to 24 months). 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 NCT06161441.

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 10 Aug 2026.

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