Phase 2/3Recruiting
A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study Evaluating the Safety and Efficacy of F520 Combined With Paclitaxel Plus Carboplatin as First-line Treatment for Cancer of Unknown Primary
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD (Industry)
- Enrolment
- 402 planned
- Conditions
- Cancer of Unknown Primary Site
- Interventions
- F520 combined with chemotherapy; placebo combined with chemotherapy
- Ages
- adults, older adults
- Registry
- NCT07761429
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate the efficacy and safety of F520 combined with paclitaxel plus carboplatin as first-line treatment for cancer of unknown primary.This study consists of two parts, with a total planned enrollment of 402 patients.Primary Endpoint is Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) based on RECIST 1.1 Secondary Endpoints included ORR、PFS、DOR；Incidence and severity of Adverse Events (AE), Serious Adverse Events (SAE), and abnormal laboratory parameters.
Primary outcomes
- PFS assessed by IRC
History
Study completion expected
Primary completion expected
Registered
Started