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.
Treatment: SKB264 · Pembrolizumab · pemetrexed · carboplatin or cisplatin — The 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.
Check if I qualifyExtracted 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
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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