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

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Durvalumab; Drug: the first line chemotherapy for metastatic NSCLC; Radiation: stereotactic body radiotherapy (SBRT)

• Registration Number: NCT04255836
• Lead Sponsor: Zhejiang Cancer Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Study Start: 2020-09-30
• Primary Completion: 2022-09-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durvalumab therapy	Durvalumab	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.
Durvalumab therapy	the first line chemotherapy for metastatic NSCLC	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.
Durvalumab therapy	stereotactic body radiotherapy (SBRT)	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.

Primary Outcome Measures

Name	Time	Method
PFS	up to 2 years	Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC

Secondary Outcome Measures

Name	Time	Method
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.
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