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

NCT04255836 | Unknown Phase 2

• 1 other identifier: ESR-19-20392
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC

  up to 2 years

Secondary Outcomes (4)

• Safety (AESI, AEs/SAEs)

  up to 2 years

• To assess the treat failure patterns

  up to 2 years

• Objective response rate(ORR)

  up to 2 years

• and OS Overall Survival(OS)

  up to 2 years

Study Arms (1)

Durvalumab therapy

EXPERIMENTAL

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

Interventions

Durvalumab DRUG

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

Also known as: IMFINZI

Durvalumab therapy

the first line chemotherapy for metastatic NSCLC DRUG

paclitaxel+carboplatin or pemetrexed+cisplatin

Durvalumab therapy

stereotactic body radiotherapy (SBRT) RADIATION

SBRT total doses of 50-60Gy/≤10F

Durvalumab therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: September 30, 2020
• Primary Completion: September 30, 2022
• Study Completion: July 30, 2023
• Last Updated: February 5, 2020

Record last verified: 2020-01