Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer

There is no report afatinib plus bevacizumab in the treatment of EGFR G719X, S768I, and L861Q single or compond mutation of metastatic non-small-cell lung cancer (NSCLC). The purpose of this study is to study afatinib combined with bevacizumab in the management of it.

Study Overview

• Status: Recruiting
• Conditions: PFS
• Intervention / Treatment: Drug: afatinib

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 afatinib plus bevacizumab in patients with metastatic NSCLC characterized by EGFRuncommon mutations with G719X, S768I, and L861Q. 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): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Qingdao, China
    • Recruiting
    • Qingdao Central Hospital
    • Contact: youxin ji; Phone Number: 86-532-68665078; Email: mdji001@gmail.com
  • Shandong
    • Qingdao, Shandong, China, 266042
      • Recruiting
      • Qingdao Central Hospital
      • Contact: songping wang, MD; Phone Number: 8653268665077; Email: ji6677@gmail.com
      • Contact: chao zhu, md; Phone Number: 8653268665077; Email: ji6677@gmail.com
      • Sub-Investigator: keke nie
      • Sub-Investigator: ling zhang
      • Sub-Investigator: shichao liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 G719X, S768I, L861Q 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

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 afatinib 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: afatinib plus bevacizumab; afatinib 40mg oral continually bevacizumab 15mg/kg, iv day 1, every 21days until disease progression, untolerated toxicities of patient death.	Drug: afatinib; afatinib 40mg oral, bevacizumab 15mg/kg iv, every 21days, until progression disease, untolerated toxicities, or patient death.; Other Names: bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	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 ]
Objective Response Rate (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 18 months

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

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

• 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: QDCH2022-02-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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