NCT06868732

Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Detailed description

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer. The primary objective of the study is to assess the efficacy and safety of JSKN016 in combination therapy in selected subjects with advanced non-small cell lung cancer.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	JSKN016	Administered intravenously according to protocol.
DRUG	Carboplatin	AUC 5, Q3W, administered intravenously according to protocol.
DRUG	Furmonertinib Mesylate	160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
DRUG	Ivonescimab	20mg/kg, Q3W, administered intravenously according to protocol.
DRUG	Docetaxel	60mg/m\^2, Q3W, administered intravenously according to protocol.
DRUG	Tislelizumab	200mg, Q3W, administered intravenously according to protocol.
DRUG	Pembrolizumab	200mg, Q3W, administered intravenously according to protocol.

Timeline

• Start date: 2025-04-02
• Primary completion: 2028-06-30
• Completion: 2028-12-30
• First posted: 2025-03-11
• Last updated: 2026-03-30

Locations

1 site across 1 country: China