Clinical trial · Interventional

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

A Randomized Controlled Multicenter Phase 2 Clinical Trial of Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in the Treatment of First-Line Newly Diagnosed Advanced Extranodal NK/T-Cell Lymphoma (ENKTL) or Non-Nasal Extranodal NK/T-Cell Lymphoma (ENKTL)

NCT07385989CI-TRIAL-00102394not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Extranodal NK/T-cell Lymphoma	Nasal Type Extranodal NK/T-Cell Lymphoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Golidocitinib in combination with P-GEMOX and PD-1 inhibitor	Drug	—	UNRESOLVED
PD-1 inhibitor in combination with P-GEMOX	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Golidocitinib + P-GemOx + PD-1 Inhibitor
description
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.
interventionNames
1. Drug: Golidocitinib in combination with P-GEMOX and PD-1 inhibitor
type
ACTIVE_COMPARATOR
label
P-GemOx + PD-1 Inhibitor
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Voluntarily provides written informed consent (ICF) prior to any study procedures.
2. Aged 18-70 years (inclusive), regardless of sex.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. 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).
5. 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).
6. Treatment-naive (no prior anti-cancer therapy for ENKTL).
7. 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.
8. 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.
9. Expected survival ≥6 months.

Exclusion Criteria:

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

References

Publications (0)

Data not yet available

No reference posted for this study.