CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 406 target
Drug / intervention
SKB264 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06448312
NCT06448312Phase 3ActiveOn Track

A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·interventional·Posted Jun 7, 2024·Updated May 8, 2026

In Brief

A Phase 3 clinical trial evaluating SKB264 and Pembrolizumab for Non-Small Cell Lung Cancer. Active but no longer recruiting, targeting 406 participants across 64 sites.

Detailed Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Active
20252026
First PostedJun 7, 2024
Enrollment StartJun 7, 2024
Primary CompletionNov 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 2.1 years agoPrimary completion in 4 months

Interventions

SKB264drug

IV Infusion

Pembrolizumabdrug

IV Infusion