SBRT/LDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1/L1 Inhibitor and Chemotherapy

Sponsor
Wuhan University
Study ID
NCT04878107
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd
  • Apatinib — DRUG
    Apatinib \[Aitan® (brand name in China)\], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor
  • Docetaxel injection — DRUG
    Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug
  • SBRT — RADIATION
    Stereotactic body radiation therapy (SBRT) is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue. SBRT involves the use of sophisticated image guidance that pinpoints the exact three-dimensional location of a tumor so that the radiation can be more precisely delivered to cancer cells.
  • LDRT — RADIATION
    low dose radation therapy

Study Details

SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumab，apatinib and SBRT/LDRT in patients with metastatic non-small Cell Lung Cancer (NSCLC) patient previously treated With PD-1/L1 Inhibitor and Chemotherapy.

Key Dates

Start date
Mar 15, 2022
Status verified
Apr 2022
Primary completion
Oct 31, 2022
Completion
Oct 31, 2023

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT/LDRT + Camrelizumab +Apatinib
    SBRT（8Gy×3f） LDRT（2Gy×5f） Camrelizumab（200mg，q3w） Apatinib （250mg，qd）
  • Active Comparator: SBRT + docetaxel
    docetaxel 75mg/m2 SBRT（8Gy×3f）

Primary Outcome Measure

Objective response rate [ Time Frame: 6 Weeks ]

Central Contacts

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