Osimertinib Combined With Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Metastatic Non-Small Cell Lung Cancer

NCT04974879 | Unknown Phase 2

• 1 other identifier: QDCH2021-07-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is no muture method to treat EGFR 20 insertion mutation non-small-cell lung cancer (NSCLC). the he purpose of this study is to study osimertinib combined with bevacizumab in the management of it.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Bronchial Neoplasms; EGFR Exon20ins Mutation

Outcome Measures

Primary Outcomes (1)

• Progression free survival

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

  18 months

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  Up to 48 months

• Overall Survival (OS)

  Up to 48 months

Study Arms (1)

study drug

EXPERIMENTAL

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

Drug: Osimertinib Oral Tablet

Interventions

Osimertinib Oral Tablet DRUG

Osimertinib, 80mg, oral daily; bevacizumab (avastin), 15mg/KG body weight, erery 21 days, intravenously.

Also known as: bevacizumab

study drug

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation 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

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Model Details: osimertinib oral and bevazizumab intravenously

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 23, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)