SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03417895
Phase
PHASE2
Status
Completed

Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — DRUG
    A humanized anti-PD-1 monoclonal antibody
  • Apatinib — DRUG
    A tyrosine kinase inhibitor selectively targeting VEGFR-2

Study Details

This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) tyrosine kinase inhibitor (TKI). The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.

Key Dates

Start date
Apr 20, 2018
Status verified
Apr 2023
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A (SHR-1210+Apatinib)
    SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD
  • Experimental: B (SHR-1210+Apatinib)
    SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (5 Days on, 2 Days off)
  • Experimental: C (SHR-1210+Apatinib)
    SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (7 Days on, 7 Days off)

Primary Outcome Measure

Adverse Event [ Time Frame: 24 months ]

Related Studies