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OncoMatch/Clinical Trials/NCT05351788

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

Is NCT05351788 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SKB264 and KL-A167 for non-small cell lung cancer.

Phase 2RecruitingSichuan Kelun Pharmaceutical Research Institute Co., Ltd.NCT05351788Data as of May 2026

Treatment: SKB264 · KL-A167 · Carboplatin · CisplatinThe purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB264 in combination with KL-A167 with or without chemotherapy with advanced or metastatic non-small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: ALK wild-type

Required: ALK wild-type

Required: EGFR activating mutation

Required: EGFR wild-type

Disease stage

Metastatic disease required

Patients with locally advanced/metastatic NSCLC; at least one measurable lesion per RECIST v1.1 criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line

Must have received: EGFR tyrosine kinase inhibitor — advanced or metastatic

who have failed previous treatment with EGFR-TKIs

Lab requirements

Blood counts

adequate organ and bone marrow function

Kidney function

adequate organ and bone marrow function

Liver function

adequate organ and bone marrow function

Adequate organ and bone marrow function

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

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