Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Cancer Center, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Surufatinib

    Drug

    250 mg, po, qd, q3w

  • Tislelizumab

    Drug

    200mg, iv, q3w

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Surufatinib + tislelizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

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

Time frame
approximately 1 years

Secondary outcomes

1

Objective response rate (ORR)

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

Time frame
approximately 1 years
2

Disease Control Rate (DCR)

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

Time frame
approximately 1 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: