NCT05587374 (GEMSTONE) is a Phase 3 clinical trial of Cadonilimab in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University.

Who is sponsoring NCT05587374?

NCT05587374 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT05587374?

Interventions in NCT05587374: Cadonilimab, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy.

What condition does NCT05587374 study?

NCT05587374 studies Nasopharyngeal Carcinoma, Nasopharyngeal Cancer.

Is NCT05587374 still recruiting?

NCT05587374 is currently active, enrolled. Last updated 23 January 2025.

Last reviewed 2025-01-23 · How we verify

NCT05587374: GEMSTONE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE)

Active, enrolled Phase 3 Last updated 23 January 2025

What this trial tests

Phase 3 trial testing Cadonilimab in Nasopharyngeal Carcinoma in 490 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 August 2023

Primary endpoint
1 August 2027

1 August 2029

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	490
Start date	1 August 2023
Primary completion	1 August 2027
Estimated completion	1 August 2029
Sites	18 locations across China

Drugs / interventions tested

Cadonilimab — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →
Cisplatin (cisplatin) — full drug profile →
Intensity-modulated radiotherapy

Conditions studied

Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
Nasopharyngeal Cancer — all drugs for Nasopharyngeal Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 65, any sex, with Nasopharyngeal Carcinoma or Nasopharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The trial aimed to compare cadonilimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in high-risk locoregionally-advanced nasopharyngeal carcinoma (LANPC).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Nasopharyngeal carcinoma: current views on the tumor microenvironment's impact on drug resistance and clinical outcomes.
Liu H, Tang L, Li Y, Xie W, et al · · 2024 · cited 85× · PMID 38254110 · DOI 10.1186/s12943-023-01928-2
Immunotherapy for nasopharyngeal carcinoma: Current status and prospects (Review).
Huang H, Yao Y, Deng X, Huang Z, et al · · 2023 · cited 78× · PMID 37417358 · DOI 10.3892/ijo.2023.5545
Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
Systemic longitudinal immune profiling identifies proliferating Treg cells as predictors of immunotherapy benefit: biomarker analysis from the phase 3 CONTINUUM and DIPPER trials.
Huang SW, Jiang W, Xu S, Zhang Y, et al · · 2024 · cited 14× · PMID 39438442 · DOI 10.1038/s41392-024-01988-w
Anti-programmed death-1 inhibitors and nimotuzumab in combination with induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a propensity score-matched analysis.
Zhang YN, Chen YP, OuYang PY, Lu TX, et al · · 2025 · cited 3× · PMID 39896749 · DOI 10.1177/17588359251316094

Verify or expand the search:

Other trials of Cadonilimab

Trials testing the same drug.

NCT07446257 — THIO and Cadonilimab in Resectable Hepatocellular Carcinoma · EARLY_PHASE1 · not yet recruiting
NCT07243951 — Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therap · Phase 2 · not yet recruiting
NCT06913218 — A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically R · Phase 1 · not yet recruiting
NCT06940921 — SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases · Phase 1, PHASE2 · active not recruiting
NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting

Other recruiting trials for Nasopharyngeal Carcinoma

Currently open trials in the same condition.

NCT06059261 — Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. · Phase 2 · recruiting
NCT07328854 — 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma · Phase 3 · recruiting
NCT06912711 — TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma · Phase 2 · recruiting
NCT07000643 — Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma · Phase 3 · recruiting
NCT06682442 — Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma · NA · recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05587374 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
Last refreshed: 23 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05587374.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing