Not yet taking people in ItalyPhase 3
Compares ivonescimab with durvalumab after chemoradiation in lung cancer that cannot be surgically removed
Compares two drugs as follow-up treatment in adults with lung cancer after chemoradiation.
Key facts
- Who runs it
- Summit Therapeutics Inc.
- Where
- Avellino, Aviano, Bergamo, Florence, Lucca, Milan, Naples, Pesaro, Peschiera del Garda, and Rome, ItalySee the 12 sitesAlso in 6 other countries, 48 sites
- Trial code
- Registry title
- A Study of Ivonescimab Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 167 people, planned
- Starts
- 1 Dec 2026
- Expected to end
- 1 Jun 2030
- Type of study
- Interventional
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Stage III lung cancer (NSCLC) that cannot be removed by surgery and has not grown after chemotherapy given together with radiation.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Non-small cell lung cancer (NSCLC), locally advanced, unresectable, Stage III
- Earlier treatment
- Must have finished platinum-based chemotherapy given together with radiation, with no disease progression afterwards. Chemotherapy after the radiation is not allowed. Must not have had anti-PD-1, anti-PD-L1 or anti-angiogenic cancer therapy before.
- Biomarker or test result
- PD-L1 status is needed, any score. A known activating EGFR mutation is not allowed.
Main reasons for not taking part
- Small cell lung cancer
- Chemotherapy and radiation given one after the other, not together
- History of noninfectious pneumonia needing steroids, or current interstitial lung disease
- Severe infection within 4 weeks before randomization
- Known activating EGFR mutation
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Participants must have histologically- or cytologically-documented NSCLC and present with locally advanced, unresectable (Stage III) disease (according to Version 9 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology])
- Participants must have received platinum-based chemotherapy concurrent with radiation therapy, which must be completed prior to their first dose of study drug. • The final chemotherapy cycle must end prior to, or concurrently with, the final dose of radiation. Consolidation chemotherapy after radiation is not permitted but administration of chemotherapy prior to concurrent chemoradiation is acceptable
- Participants must have PD-L1 status with any tumor proportion score (TPS)/tumor cell (TC) score in tumor tissue
- Participants must not have experienced disease progression as defined by RECIST 1.1 criteria following definitive, platinum-based, cCRT
- Age ≥ 18 years old at the time of enrollment
Who cannot take part
- Participants who receive sequential chemoradiation (CRT) for locally advanced NSCLC
- Any ongoing concomitant chemotherapy, or any immunotherapy, biologic or hormonal therapy for cancer treatment
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or to anti-angiogenic therapy administered as anti-cancer therapy
- History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease, including any active or Grade 2 or higher pneumonitis resulting from prior cCRT
- Severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)
- Known presence of an activating epidermal growth factor receptor (EGFR) mutation based on molecular testing of the tumor or plasma-based testing
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
Where in Italy
Also in 6 other countries, 48 sites
- AORN San Giuseppe Moscati AvellinoAvellino, ItalyNot yet recruiting
- Centro di Riferimento Oncologico di AvianoAviano, ItalyNot yet recruiting
- Cliniche Gavazzeni S.p.A.Bergamo, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Unita' Sanitaria Locale Toscana Nord OvestLucca, ItalyNot yet recruiting
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyNot yet recruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyNot yet recruiting
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyNot yet recruiting
- Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, ItalyNot yet recruiting
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.Peschiera del Garda, ItalyNot yet recruiting
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyNot yet recruiting
About the trial
What the trial wants to find out
To compare progression-free survival (PFS) assessed by independent radiographic review committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 between ivonescimab and durvalumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Open-label Study of Ivonescimab Versus Durvalumab as Consolidation Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Experienced Disease Progression Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (HARMONi-10)
- Plain-language title
- Compares ivonescimab with durvalumab after chemoradiation in lung cancer that cannot be surgically removedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 13 November 2026