A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- Durvalumab
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 35
- Primary Endpoint
- PFS
- Last Updated
- 6 years ago
Overview
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).
Investigators
Eligibility Criteria
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).
Arms & Interventions
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.
Intervention: Durvalumab
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.
Intervention: the first line chemotherapy for metastatic NSCLC
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.
Intervention: stereotactic body radiotherapy (SBRT)
Outcomes
Primary Outcomes
PFS
Time Frame: up to 2 years
Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
Secondary Outcomes
- Objective response rate(ORR)(up to 2 years)
- and OS Overall Survival(OS)(up to 2 years)
- Safety (AESI, AEs/SAEs)(up to 2 years)
- To assess the treat failure patterns(up to 2 years)