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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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
paclitaxel+carboplatin or pemetrexed+cisplatin
SBRT total doses of 50-60Gy/≤10F
PFS
Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
Time frame: up to 2 years
Safety (AESI, AEs/SAEs)
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]
Time frame: up to 2 years
To assess the treat failure patterns
Treat failure patterns including local failure and distant metastasis
Time frame: up to 2 years
Objective response rate(ORR)
ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: up to 2 years
and OS Overall Survival(OS)
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Time frame: up to 2 years
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