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A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)

NCT07761429 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2026-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Cancer of Unknown Primary Site

Interventions

DRUG

F520 combined with chemotherapy

F520: 200 mg per dose, intravenous infusion, infusion time \>30 minutes, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel: 175 mg/m², intravenous infusion, infusion time \>3 hours, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details. Carboplatin: AUC 5, intravenous infusion, infusion time \>30 minutes, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details.

DRUG

placebo combined with chemotherapy

Placebo: 200 mg per dose, intravenous infusion, infusion time \>30 minutes, Q3W; maximum 2 years. Refer to drug preparation manual for details. Paclitaxel: 175 mg/m², intravenous infusion, infusion time \>3 hours, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details. Carboplatin: AUC 5, intravenous infusion, infusion time \>30 minutes, Q3W, recommended for 6 cycles (may be extended if investigator assesses continued benefit). Refer to package insert for details.

Sponsors & Collaborators

  • Shandong New Time Pharmaceutical Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-08
Primary Completion
2027-12-30
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761429 on ClinicalTrials.gov