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AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2023-08-17
View on ClinicalTrials.gov ↗

Amendment history

2025-04-30
Recruiting→Active, Not Recruiting Study Status, Study Design, Eligibility, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-12-20→confirmed 2025-02-28
Completion date2025-12-20→2026-12-31
Enrollment targetestimated 396→confirmed 532
Eligibility criteria+2 characters
[...] articipation (including all study procedures). ≥18 years old and ≤75 years old (at the time consent is obtained). Has an Eastern Cooperativ [...] a life expectancy of at least 3 months. Has a histologically or cytologically confirmed diagnosis of squamous NSCLC. Has Stage IIIB/C or [...]
Study sitesdetails revised at 1 of 1 site
2023-08-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-06-20→confirmed 2023-08-17
Study sites0→1
2023-04-21
Original filing
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.
Trial Details
NCT Number NCT05840016
Lead Sponsor Akeso
Conditions Advanced Squamous Non Small Cell Lung Cancer
Enrollment 532 participants
Start Date 2023-08-17
Primary Completion 2025-02-28 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-02