A Study of Ivonescimab Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC
Key facts
- Where
- Avellino, Aviano, Bergamo, Florence, Lucca, Milan, Naples, Pesaro, Peschiera del Garda és Rome, OlaszországSee the 12 sites
- Phase
- 3. fázis
Where in Olaszország
- AORN San Giuseppe Moscati AvellinoAvellino, OlaszországToborzás még nem indult
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországToborzás még nem indult
- Cliniche Gavazzeni S.p.A.Bergamo, OlaszországToborzás még nem indult
- Azienda Ospedaliero-Universitaria CareggiFlorence, OlaszországToborzás még nem indult
- Azienda Unita' Sanitaria Locale Toscana Nord OvestLucca, OlaszországToborzás még nem indult
- ASST Grande Ospedale Metropolitano NiguardaMilan, OlaszországToborzás még nem indult
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, OlaszországToborzás még nem indult
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, OlaszországToborzás még nem indult
- Azienda Sanitaria Territoriale di Pesaro e UrbinoPesaro, OlaszországToborzás még nem indult
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.Peschiera del Garda, OlaszországToborzás még nem indult
- I.F.O. Istituti Fisioterapici OspitalieriRome, OlaszországToborzás még nem indult
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?
Trial details
- Who runs it
- Summit Therapeutics Inc.
- Trial code
- EU 2026-526300-67-00
- Record updated
- 2026. november 9.
- Original description
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 durvalumabRead full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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.