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Sequential Envafolimab after Almonertinib in EGFR+ PD-L1+ NSCLC
NCT05534113Phase 2
Key facts
- Status
- Unknown
- Start
- Dec 2022
- Primary completion
- Jun 2025
- Sponsor
- Jiangsu Provincial People's Hospital
- Modality
- Nanobodies (VHH), Monoclonal Antibodies
- Drugs
- envafolimab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of envafolimab in non-small cell lung cancer (NSCLC), sponsored by Jiangsu Provincial People's Hospital. Primary endpoints: Progression-Free Survival at 24 months and Time to Radiological Progression at 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sequential Envafolimab
Almonertinib induction followed by Envafolimab maintenance upon ctDNA clearance
03
Who it enrols
Patients with unresectable advanced or metastatic non-squamous NSCLC, EGFR mutation positive (Exon 19 del or L858R), PD-L1 positive (TPS >= 10%), and no prior systemic treatment.
04
Endpoints
Primary
Progression-Free Survival
Time to Radiological Progression
Secondary
Objective Response Rate
Disease Control Rate
Overall Survival
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