Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer

There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: osimertinib oral and bevazizumab intravenously

Detailed Description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266042
      • Recruiting
      • Qingdao Central Hospital, Qingdao Cancer Hospital
      • Sub-Investigator: Keke Nie, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.

Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.

Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.

A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.

Exclusion Criteria:

Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.

Participant has a contraindication to the use Osimertinib or Bevacizumab.

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: study drug; osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days	Drug: osimertinib oral and bevazizumab intravenously; osimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days.; Other Names: bevacizumab; osimertinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.	Up to 48 months
ORR	ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.	Up to 48 months

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Bevacizumab; Osimertinib; Bronchial Neoplasms; EGFR Mutation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Osimertinib
• Other Study ID Numbers: QDCH2021-10-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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