A Study of SHR-1210 in Combination With Apatinib in Advanced Non-Small Cell Lung Cancer(NSCLC)

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03083041
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • SHR-1210 — BIOLOGICAL
    SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
  • Apatinib — DRUG
    Apatinib tablet will be administered orally,once daily until progression

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 two dose levels in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). The study is composed of two parts. Part 1 of the study will determine the safety, tolerability and pharmacokinetics of SHR-1210 in combination with Apatinib. Part 2 includes a randomized comparison of Apatinib 250mg/d or 500mg/d plus SHR-1210. Subject's tumors will be screened at baseline for EGFR mutations, EML4-ALK translocation, and PD-L1 expression.But positive tumor PD-L1 expression will not be required for enrollment.

Key Dates

Start date
Mar 13, 2017
Status verified
Jun 2022
Primary completion
Apr 22, 2022
Completion
Apr 22, 2022

Study Design

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

Arms

  • Experimental: SHR-1210，200mg,q2w plus apatinib 250mg/d
    SHR-1210 200mg, IV, Q2W and Apatinib 250mg, PO, QD
  • Experimental: SHR-1210，200mg,q2w plus apatinib 500mg/d
    SHR-1210 200mg, IV, Q2W and Apatinib 500mg, PO, QD
  • Experimental: SHR-1210，200mg,q2w plus apatinib 375mg/d
    SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD

Primary Outcome Measure

Incidence and Grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: from signing the informed consent form to safety follow-up, 61 months ]

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