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NCT06414915Not yet recruitingPhase 2

Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation

A Single-arm, Open, Single-center, Prospective and Exploratory Clinical Study of Surufatinib Combined With Tislelizumab in the Treatment of Advanced Lung Cancer With Neuroendocrine Differentiation

Source: ClinicalTrials.gov · Last updated 16 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
29 (estimated)
First submitted
10 May 2024
Start date
1 Jun 2024
Primary completion date
1 Jun 2026
Lead sponsor
National Cancer Center, China
Diseases
Lung cancer
NCT number
NCT06414915

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 29
  • From 1 Jun 2024 to the primary completion date, 1 Jun 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior anti-VEGF/VEGFR-targeted therapy or anti-PD (L)1 antibody;
  • Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Other illness

  • 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

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

Who the study is looking for

  • 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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.