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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Durvalumab; Radiation: stereotactic body radiotherapy (SBRT); Drug: the first line chemotherapy for metastatic NSCLC

Study type: Interventional

Funder types: Other

Identifiers

NCT04255836

ESR-19-20392

Details and patient eligibility

About

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).

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Durvalumab therapy

Experimental group

Description:

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.

Treatment:

Radiation: stereotactic body radiotherapy (SBRT)

Drug: the first line chemotherapy for metastatic NSCLC

Drug: Durvalumab