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OncoMatch/Clinical Trials/NCT06711900

A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Is NCT06711900 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including SKB264 and Pembrolizumab for non-small cell lung cancer.

Phase 3RecruitingSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.NCT06711900Data as of May 2026

Treatment: SKB264 · Pembrolizumab · pemetrexed · carboplatin or cisplatinThe study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR wild-type

EGFR-sensitive mutation negative [no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)]

Required: ALK wild-type

ALK fusion gene negative

Required: ROS1 wild-type

without known ROS1 gene fusion

Required: NTRK1 wild-type

without known ... NTRK gene fusion

Required: NTRK2 wild-type

without known ... NTRK gene fusion

Required: NTRK3 wild-type

without known ... NTRK gene fusion

Required: BRAF wild-type

without known ... BRAF V600E mutation

Required: PD-L1 (CD274) PD-L1 TPS < 1% (< 1%)

Participants whose tumours are PD-L1 TPS < 1%

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anti-cancer therapy

No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC

Cannot have received: immune checkpoint inhibitor

Previously received immune checkpoint inhibitors, checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy

Lab requirements

Blood counts

adequate organ and bone marrow function

Kidney function

Liver function

Adequate organ and bone marrow function

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

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