Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT04255836
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months
  • the first line chemotherapy for metastatic NSCLC — DRUG
    paclitaxel+carboplatin or pemetrexed+cisplatin
  • stereotactic body radiotherapy (SBRT) — RADIATION
    SBRT total doses of 50-60Gy/≤10F

Study Details

This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).

Key Dates

Start date
Sep 30, 2020
Status verified
Jan 2020
Primary completion
Sep 30, 2022
Completion
Jul 30, 2023

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab therapy
    Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks \[q3w\] intravenously \[iv\] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.

Primary Outcome Measure

PFS [ Time Frame: up to 2 years ]

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