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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Durvalumab; Drug: the first line chemotherapy for metastatic NSCLC; Radiation: stereotactic body radiotherapy (SBRT)

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Durvalumab; 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; Other Names: IMFINZI; Drug: the first line chemotherapy for metastatic NSCLC; paclitaxel+carboplatin or pemetrexed+cisplatin; Radiation: stereotactic body radiotherapy (SBRT); SBRT total doses of 50-60Gy/≤10F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (AESI, AEs/SAEs)	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	up to 2 years
To assess the treat failure patterns	Treat failure patterns including local failure and distant metastasis	up to 2 years
Objective response rate(ORR)	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.	up to 2 years
and OS Overall Survival(OS)	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.	up to 2 years

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Durvalumab
• Other Study ID Numbers: ESR-19-20392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No