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

NCT05104281 | Unknown Phase 3 DMC

• 1 other identifier: QDCH2021-10-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Bronchial Neoplasms; EGFR Mutation; Osimertinib; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)

  30 months

Secondary Outcomes (2)

• OS

  Up to 48 months

• ORR

  Up to 48 months

Study Arms (1)

study drug

EXPERIMENTAL

osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days

Drug: osimertinib oral and bevazizumab intravenously

Interventions

osimertinib oral and bevazizumab intravenously DRUG

osimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days.

Also known as: bevacizumab, osimertinib

study drug

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

RECRUITING

Related Publications (1)

• Zhang L, You Y, Liu X, Liu F, Nie K, Ji Y. Osimertinib combined with bevacizumab as the first-line treatment in non-small cell lung cancer patients with brain metastasis harboring epidermal growth factor receptor mutations. Thorac Cancer. 2023 May;14(15):1355-1361. doi: 10.1111/1759-7714.14880. Epub 2023 Apr 5.

  PMID: 37016906 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms

Interventions

osimertinib; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)