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Ivonescimab Injection / ALK201 for injection / NSCLC (advanced Non Small Cell Lung Cancer) · Phase 2 Trial
ClinicalTrials.gov · August 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for ALK201 combined with ivonescimab in FGFR2b-positive, EGFR wild-type, ALK-negative squamous NSCLC. No results are posted; the trial is not yet recruiting. The evidence base is therefore absent and clinicians should await outcome data before any clinical inference.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. NSCLC (Advanced Non-small Cell Lung Cancer); age from 18 Years; to 75 Years. Intervention: Primary cohort; Exploratory cohort. n = 156. Multicenter (specific sites not listed in registry record).
This is a Phase 2 trial registration for ALK201 combined with ivonescimab in FGFR2b-positive, EGFR wild-type, ALK-negative squamous NSCLC. No results are posted; the trial is not yet recruiting. The evidence base is therefore absent and clinicians should await outcome data before any clinical inference.
Study is not yet recruiting; enrollment and safety/efficacy data are prospective only.
This trial is in early recruitment phase with no clinical data yet available. Clinicians and researchers should monitor ClinicalTrials.gov for results when the trial concludes; current evidence for this regimen is unavailable.
This is a Phase 2 trial registration with no posted results; the study is not yet recruiting and planned enrollment is modest, making it too early to assess efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
This trial is in early recruitment phase with no clinical data yet available. Clinicians and researchers should monitor ClinicalTrials.gov for results when the trial concludes; current evidence for this regimen is unavailable.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07742956). This is a study registration, not published results. Lead sponsor: Shanghai Allink Biotherapeutics Co., Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 156 participants (ESTIMATED). Conditions: NSCLC (Advanced Non-small Cell Lung Cancer). Interventions: DRUG: ALK201 for injection; DRUG: Ivonescimab Injection. Primary outcome measures: TEAEs , Up to 24 months. Brief summary: This is an open-label, multicenter, Phase II clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ALK201 for Injection combined with Ivonescimab Injection in adult patients with locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) who are FGFR2b-positive, EGFR mutation-negative, and ALK-negative. The study consists of two parts: Part A (dose escalation) and Part B (dose optimization). Part A Dose Escalation Stage: This stage includes three dose levels. Eligible patients with locally advanced or metastatic sqNSCLC who have failed standard therapy will be enrolled to complete DLT assessment. Part B Dose Optimization Stage: This stage comprises two cohorts, enrolling eligible patients with locally advanced or metastatic sqNSCLC satisfying the respective cohort criteria: Primary cohort: PD-L1 expression ≥1% Exploratory cohort: PD-L1 expression \<1%
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.