OncoMatch/Clinical Trials/NCT07761429
A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)
Is NCT07761429 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2/3 trial studies F520 combined with chemotherapy for cancer of unknown primary site.
Treatment: F520 combined with chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Excluded: ALK fusion
Excluded: BRAF mutation suitable for molecular targeted therapy
Excluded: EGFR sensitizing mutation
Excluded: NTRK1 fusion
Excluded: NTRK2 fusion
Excluded: NTRK3 fusion
Excluded: Mismatch-repair deficient (MSI-H / dMMR)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: taxane
Prior treatment with taxanes
Cannot have received: platinum-based chemotherapy
Prior treatment with platinum-based chemotherapy
Cannot have received: immune checkpoint inhibitor (anti-PD-1 therapy, anti-PD-L1 therapy)
prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1) or any tumor immunotherapy
Cannot have received: tumor immunotherapy
prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1) or any tumor immunotherapy
Lab requirements
Blood counts
anc ≥1.5×10⁹/l; platelet count ≥90×10⁹/l; hemoglobin (hb) ≥90 g/l
Kidney function
serum creatinine (cr) ≤1.25×uln
Liver function
ast, alt ≤2.5×uln; total bilirubin (tbil) ≤1.5×uln; if liver metastases present: ast and alt ≤5×uln, tbil ≤3×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07761429 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
Are patients with BRAF alterations eligible?
No. BRAF mutation suitable for molecular targeted therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify