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OncoMatch/Clinical Trials/NCT05899608

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

Is NCT05899608 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Ivonescimab and Pembrolizumab for non-small cell lung cancer.

Phase 3RecruitingSummit TherapeuticsNCT05899608Data as of Jun 2026Location: International · 17 countries

Treatment: Ivonescimab · PembrolizumabThis 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

IvonescimabPembrolizumab

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)

Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization

Excluded: EGFR actionable genomic alteration

Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

Excluded: ALK actionable genomic alteration

Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

Excluded: ROS1 actionable genomic alteration

Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

Excluded: BRAF V600E

Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Banner University Medical Center · Phoenix, Arizona
  • TMC Healthcare · Tucson, Arizona
  • Genesis Cancer and Blood Institute · Hot Springs, Arkansas
  • University of Arkansas · Little Rock, Arkansas
  • LA Cancer Network · Anaheim, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05899608 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD274?

Yes, CD274 expression is a required biomarker for enrollment.

Are patients with EGFR alterations eligible?

No. EGFR actionable genomic alteration is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK actionable genomic alteration is an exclusion criterion.

What disease stage is eligible?

Stage IV is required (metastatic disease required).

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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