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

• Status: Not yet recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Antibodies, Monoclonal; Durvalumab

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).