Plain-language summary

This Phase 2 trial is comparing different first-line treatment approaches for people newly diagnosed with NK/T-cell lymphoma. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

• Age 18 Years to 70 Years years
• Newly diagnosed, not yet treated
• Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Golidocitinib in combination with P-GEMOX and PD-1 inhibitor (DRUG): Participants receive this combination for 6 cycles of induction therapy. Those achieving complete response (CR) or partial response (PR) post-induction will continue maintenance therapy with golidocitinib plus PD-1 inhibitor (same dosage and administration schedule) for 1 year, or until disease progression, unacceptable toxicity, or voluntary withdrawal from the study. This regimen is designed to target the STAT3 signaling pathway (via golidocitinib) while combining cytotoxic chemotherapy (P-GEMOX) and immune checkpoint inhibition (PD-1 inhibitor) for synergistic anti-lymphoma activity. | PD-1 inhibitor in combination with P-GEMOX (DRUG): Participants receive this combined regimen for 6 cycles of induction therapy. For those achieving complete response (CR) or partial response (PR) post-induction, maintenance therapy is continued with PD-1 inhibitor alone (same 200 mg intravenous dose on Day 1 of each 21-day cycle) for 1 year, or until disease progression, unacceptable treatment-related toxicity, or study discontinuation. This regimen represents a currently established first-line therapeutic option for advanced/non-nasal ENKTL, serving as the active comparator for evaluating the added benefit of golidocitinib in the experimental arm.

Drugs / treatments

Golidocitinib in combination with P-GEMOX and PD-1 inhibitor, PD-1 inhibitor in combination with P-GEMOX

Treatment length

Ask the trial team for details

Visit frequency

Ask the trial team for details