NCT07669779 Ivonescimab Advanced Lung Non-Small Cell Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07669779—A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07669779 is a hot trial to watch

Advanced Lung Non-Small Cell Carcinoma is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07669779 is notable because it evaluates Ivonescimab in a Phase 2 design while DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug. serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment of 348 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Primary: DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug. (During the first 3 weeks of treatment in Safety Run-in Phase.)
• Primary: AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment. (From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.)
• Primary: ORR is the proportion of participants with complete response(CR) or partial response(PR) , assessed based on RECIST v1.1. (Up to approximately 2 years.)
• Secondary: PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first. (Up to approximately 2 years.)
• Secondary: DCR is defined as the proportion of participants with CR, PR, or SD, assessed based on RECIST v1.1. (Up to approximately 2 years.)

Benchmark readouts in the surrounding field

• A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation (Phase 3): Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)(Median): Hazard Ratio (HR) = 0.96(95% CI, 0.75 - 1.23), P-Value = 0.7586; Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)(Median) = 19.35 months (95% Confidence Interval, 13.80 - 29.47)
• Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (Phase 2): Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG): P-Value = 0.6585; Percentage of Participants Alive Without Local-regional Progression [Local-regional Progression-free (LRPF) Survival] at Two Years (NRG): P-Value = 0.6585
• 148TiP - A phase III trial of a PD-1/VEGF bispecific antibody (PF-08634404) vs pembrolizumab in combination with platinum-based chemotherapy in first-line for locally advanced or metastatic non-small cell lung cancer (Symbiotic-Lung-01) (Phase 3): mOS = NR month ( 36.3 - NR); mOS = NR month ( 36.2 - NR)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Ivonescimab (Approved; PD-1 x VEGF-A); Osimertinib mesylate (Approved; EGFR L858R x EGFR T790M x EGFR-Ex19del); AK146D1 (Phase 2; Trop-2 x nectin-4)

Company & Deal Intelligence context: Akeso Biopharma Co., Ltd. — China — http://www.akesobio.com

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07669779 is a focused lens on Advanced Lung Non-Small Cell Carcinoma development. Its value will be determined by whether Ivonescimab can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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