NCT06480136

SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment

An Exploratory Clinical Study of SHR-A1921 Combined With Adebrelimab in the Treatment of Advanced NSCLC Who Failed the Previous Standard First-line Treatment

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II clinical study to evaluate the efficacy and safety of SHR-A1921 conbined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Subjects in this study were treated with SHR-A1921 in combination with adebrelimab until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication, whichever occurred first. The maximum treatment time of adebrelimab is 35 cycles or 2 years (whichever comes first), and subjects can continue to be treated with SHR-A1921 until disease progression, intolerable toxicity occurs, informed consent is withdrawn, or other conditions requiring termination of medication. Primary objective of this study was to evaluate the efficacy of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy. Secondary objective of this study was to evaluate the safety of SHR-A1921 combined with adebrelimab in advanced NSCLC who failed the previous first-line standard therapy; Exploratory objective of this study was to evaluate the biomarker changes during treatment with SHR-A1921 combined with adebrelimab in patients with advanced NSCLC who failed the previous first-line standard therapy.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	SHR-A1921 injection and adebrelimab injection	The Treatment group receive SHR-A1921 injection combined with adebrelimab injection

Timeline

• Start date: 2024-07-15
• Primary completion: 2027-06-15
• Completion: 2028-02-15
• First posted: 2024-06-28
• Last updated: 2024-06-28