Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in First-Line Newly Diagnosed Advanced or Non-Nasal Extranodal NK/T-Cell Lymphoma

NCT07385989 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-SR-682
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, Phase 2 clinical trial designed to evaluate the efficacy and safety of golidocitinib combined with the P-GemOx (pegaspargase + gemcitabine + oxaliplatin) regimen plus PD-1 inhibitor, compared with P-GemOx plus PD-1 inhibitor alone, in participants with first-line newly diagnosed advanced (Stage III-IV) or non-nasal extranodal natural killer/T-cell lymphoma (ENKTL). Eligible participants will be randomly assigned 1:1 to two groups: Experimental group: Golidocitinib (150 mg orally once daily, Days 1-21 per 21-day cycle) + P-GemOx (pegaspargase 2000 U/m² on Day 2; gemcitabine 1000 mg/m² on Day 1; oxaliplatin 100 mg/m² on Day 1, per 21-day cycle) + PD-1 inhibitor (200 mg intravenously on Day 1 per 21-day cycle). Control group: P-GemOx + PD-1 inhibitor (same dosage/schedule as the experimental group, without golidocitinib). All participants will receive 6 cycles of induction therapy. Those achieving CR or partial response (PR) after induction will receive maintenance therapy for 1 year: the experimental group will continue golidocitinib + PD-1 inhibitor, while the control group will receive PD-1 inhibitor alone (both per 21-day cycles). The primary outcome is the complete response rate (CRR) after 6 induction cycles (assessed per the 2014 Lugano Classification for Lymphoma). Secondary outcomes include overall response rate (ORR), 2-year progression-free survival (PFS), 2-year overall survival (OS), and the incidence of treatment-related adverse events (graded per NCI-CTCAE Version 5.0). 40 participants will be enrolled across multiple Chinese medical centers. This Phase 2 trial will provide preliminary evidence to determine whether the golidocitinib combination regimen is a safe and effective first-line option for advanced or non-nasal ENKTL.

Conditions

Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR) After 6 Cycles of Induction Therapy

  The proportion of evaluable participants who achieve complete response (CR) following 6 cycles of induction therapy. CR is defined in accordance with the 2014 Lugano Classification for Lymphoma: this requires the complete disappearance of all measurable/evaluable lymphoma lesions, resolution of all disease-related clinical symptoms, and normalization of imaging findings (e.g., no residual measurable disease on CT/MRI, and no metabolically active disease on FDG-PET/CT). The analysis population is restricted to participants who complete at least 4 cycles of induction therapy and have available post-treatment efficacy assessment data.

  Within 21 days after the completion of the 6th cycle of induction therapy (Each cycle is 21 days)

Secondary Outcomes (4)

• Overall Response Rate (ORR) After 6 Cycles of Induction Therapy

  Within 21 days after the completion of the 6th cycle of induction therapy At the end of Cycle 1 (each cycle is 28 days)

• 2-Year Progression-Free Survival (PFS)

  Up to 2 years after randomization

• 2-Year Overall Survival (OS)

  Up to 2 years after randomization

• Incidence of Treatment-Related Adverse Events (TRAE)

  From the first dose of study intervention to 30 days after the last dose of study intervention

Study Arms (2)

Golidocitinib + P-GemOx + PD-1 Inhibitor

EXPERIMENTAL

Golidocitinib (150 mg orally once daily, Days 1-21) Pegaspargase (2000 U/m² intravenously, Day 2) Gemcitabine (1000 mg/m² intravenously, Day 1) Oxaliplatin (100 mg/m² intravenously, Day 1) PD-1 inhibitor (200 mg intravenously, Day 1) Participants receive 6 cycles of induction therapy; those achieving complete response (CR) or partial response (PR) will continue maintenance therapy (Golidocitinib + PD-1 inhibitor, same dosage/schedule) for 1 year or until disease progression.

Drug: Golidocitinib in combination with P-GEMOX and PD-1 inhibitor

P-GemOx + PD-1 Inhibitor

ACTIVE COMPARATOR

Pegaspargase (2000 U/m² intravenously, Day 2) Gemcitabine (1000 mg/m² intravenously, Day 1) Oxaliplatin (100 mg/m² intravenously, Day 1) PD-1 inhibitor (200 mg intravenously, Day 1) Participants receive 6 cycles of induction therapy; those achieving complete response (CR) or partial response (PR) will continue maintenance therapy (PD-1 inhibitor alone, same dosage/schedule) for 1 year or until disease progression.

Drug: PD-1 inhibitor in combination with P-GEMOX

Interventions

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.

Golidocitinib + P-GemOx + PD-1 Inhibitor

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.

P-GemOx + PD-1 Inhibitor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provides written informed consent (ICF) prior to any study procedures.
• Aged 18-70 years (inclusive), regardless of sex.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed extranodal NK/T-cell lymphoma (ENKTL), staged as Stage III-IV or non-nasal ENKTL (per 2016 WHO Classification of Hematopoietic and Lymphoid Tumors).
• At least one measurable/evaluable lesion (per 2014 Lugano Classification: measurable lesion ≥1.5 cm in longest diameter + ≥1.0 cm in shortest diameter; evaluable lesion with FDG uptake higher than liver on PET/CT).
• Treatment-naive (no prior anti-cancer therapy for ENKTL).
• Adequate organ function:
• AST/ALT ≤2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine \<1.5×ULN or creatinine clearance (CrCl, via Cockcroft-Gault formula) ≥60 mL/min.
• Reproductive-aged females have a negative pregnancy test at screening; all participants use effective contraception during the study and for 12 months after the last dose.
• Expected survival ≥6 months.

You may not qualify if:

• Complicated by hemophagocytic lymphohistiocytosis (HLH) or aggressive NK-cell leukemia.
• Contraindication to golidocitinib, PD-1 inhibitor, or any component of the P-GEMOX regimen.
• Lymphoma involvement of the central nervous system (CNS).
• Major surgery (excluding diagnostic biopsy) within 4 weeks prior to study treatment initiation.
• History of other malignant tumors (except curatively treated in situ cancers, e.g., cervical carcinoma in situ) within 5 years.
• Uncontrolled severe comorbidities (e.g., NYHA Class II+ heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmias).
• Active bleeding (e.g., gastrointestinal hemorrhage, cerebral hemorrhage).
• Uncontrolled infection (requiring parenteral anti-infective therapy) within 7 days prior to study treatment.
• Active hepatitis B/C: HBsAg+/HBcAb+ with HBV-DNA \>2500 copies/mL (or 500 IU/mL); HCV antibody+ with positive HCV-RNA.
• HIV infection or acquired immunodeficiency syndrome (AIDS).
• Conditions impairing drug absorption (e.g., inability to swallow tablets, malabsorption syndrome).
• Pregnant/lactating females, or reproductive-aged participants refusing contraception.
• Psychiatric illness precluding informed consent or study compliance.
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• WEI XU: lead

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Wei Xu

CONTACT

13951699449; xuwei10000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Hematology

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: January 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 4, 2026

Record last verified: 2026-01