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NCT05899608

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

Recruiting now Phase 3 Last updated 7 January 2026
What this trial tests

Phase 3 trial testing Ivonescimab Injection in Non-Small Cell Lung Cancer in 1,600 participants. Currently enrolling.

Timeline
26 October 2023
Primary endpoint
31 December 2028
31 December 2029

Quick facts

Lead sponsorSummit Therapeutics
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment1,600
Start date26 October 2023
Primary completion31 December 2028
Estimated completion31 December 2029
Sites244 locations across France, Italy, Japan, Greece, Belgium, Serbia, Sweden, Ireland

Drugs / interventions tested

Conditions studied

Sponsor

Summit Therapeutics — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibodies to watch in 2024.
    Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
  2. Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors.
    Frentzas S, Austria Mislang AR, Lemech C, Nagrial A, et al · · 2024 · cited 46× · PMID 38642937 · DOI 10.1136/jitc-2023-008037
  3. Unlocking new horizons in oncology: ivonescimab's dual-target approach to anti-VEGF/PD-1(L1) therapy.
    Shi F, Yang L, Gao Y, Hou Y, et al · · 2025 · cited 4× · PMID 41333457 · DOI 10.3389/fimmu.2025.1599181
  4. Next-generation immunotherapy: igniting new hope for lung cancer.
    Li MSC, Chan ALS, Mok KKS, Chan LL, et al · · 2024 · cited 3× · PMID 39649017 · DOI 10.1177/17588359241302021
  5. Rewiring the immune response in lung cancer: current progress in bispecific antibodies, CAR-T therapy, and the rise of <i>in vivo</i> CAR-T platforms.
    He L, Sun Y, Ma B, Lang G, et al · · 2026 · PMID 42093990 · DOI 10.3389/fimmu.2026.1772428
  6. An evolving landscape: predictive and therapeutic biomarkers in advanced non-small cell lung cancer.
    Fortman D, Qin A. · · 2026 · PMID 41889421 · DOI 10.3389/fonc.2026.1750153
  7. Anti-angiogenic therapies in cancer: from endogenous inhibitors to bispecific VEGF x PD-(L)1 antibodies.
    Álvarez-Vallina L, Sanz L. · · 2026 · PMID 41659853 · DOI 10.3389/fimmu.2026.1736806
  8. LEAP-006: limits and potential of integrating anti-angiogenic agents into first-line multimodal therapy for non-squamous non-small cell lung cancer.
    Santo V, Garbo E, Pecci F, Aldea M, et al · · 2025 · PMID 41522173 · DOI 10.21037/jtd-2025-aw-2034

Verify or expand the search:

Other recruiting trials for Non-Small Cell Lung Cancer

Currently open trials in the same condition.

Other Summit Therapeutics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05899608.

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