Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
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).
Interventions
DRUGDurvalumab
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
DRUGthe first line chemotherapy for metastatic NSCLC
paclitaxel+carboplatin or pemetrexed+cisplatin
RADIATIONstereotactic body radiotherapy (SBRT)
SBRT total doses of 50-60Gy/≤10F
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-small cell lung cancer * ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node * metastasis一group lymph node region will be classified as one metastatic lesion） * Tissue biopsy prior to treatment * ECOG performance score 0-1
Exclusion criteria
* EGFR mutation or ALK positive. * Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia. * Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. * Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 2 years | Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (AESI, AEs/SAEs) | up to 2 years | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
| To assess the treat failure patterns | up to 2 years | Treat failure patterns including local failure and distant metastasis |
| Objective response rate(ORR) | up to 2 years | 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. |
| and OS Overall Survival(OS) | up to 2 years | 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. |
Outcome results
None listed