Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06414915

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Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

Interventionnel

Phase 2

Sponsor: National Cancer Center, China

Dernière synchronisation : 16 mai 2024
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

Currently, there are no standard treatment and relevant exploration for NSCLC patients with NED. The study aims to explore the efficacy and safety of surufatinib combined with tislelizumab in the treatment of NSCLC with NED, in order to provide a new treatment option for NSCLC patients with NED.

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Catégorie de traitement

Médicament

Mutations requises

Aucun

Essai commencé

1 juin 2024

Dernière mise à jour par le sponsor

16 mai 2024

Achèvement estimé

1 juin 2026

Contact de l'étude

Nom:Puyuan Xing, Doctorate

E-mail:xingpuyuan@cicams.ac.cn

Téléphone:+86-10-87787421

Éligibilité

Critères d'inclusion

* Histopathologically confirmed locally advanced or metastatic unresectable lung cancer (IIIB-IV) with an abnormal NED or NE phenotype (without neuroendocrine morphologic features and positive immunohistochemical expression of at least one neuroendocrine marker (CD56, CgA, Syn));

* Have at least one measurable lesion according to RECIST v1.1;

* ECOG performance status: 0-1;

* Patients who were deemed by the investigator to be eligible for first-line single-agent immunotherapy or who progressed on first-line standard therapy;

* Urine protein \< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g;

* Expected survival time \> 3 months;

Critères d'exclusion

* Pulmonary neuroendocrine tumors (typical carcinoid, atypical carcinoid, small cell carcinoma, large cell neuroendocrine carcinoma);

* Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;

* Have uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mm Hg, while under anti-hypertension treatment;

* Patients with active ulcer, intestinal perforation and intestinal obstruction;

* With active bleeding or bleeding tendency;

* Severe history of cardiovascular and cerebrovascular diseases;

* Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

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Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire29

Bras et interventions

Bras

Interventions

Type : Experimental

Description :

Interventions :

Surufatinib
Tislelizumab

Mesures des résultats

Mesures des résultats primaires

Progression-Free Survival (PFS)approximately 1 years

time from first-dose to the first documented disease progression or death

Mesures des résultats secondaires

Disease Control Rate (DCR)approximately 1 years

the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Objective response rate (ORR)approximately 1 years

the proportion of patients with complete response or partial response, using RESIST v1.1

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