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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

Sponsor
Qingdao Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05267288
Collaborator
(none)
30
Enrollment
2
Locations
1
Arm
27.9
Anticipated Duration (Months)
15
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [up to 18 months]

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

    Secondary Outcome Measures

    1. overall survival [Up to 48 months ]]

      Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

    2. Objective Response Rate (ORR) [up to 18 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Qingdao Central Hospital Qingdao Shandong China 266042
    2 Qingdao Central Hospital Qingdao China

    Sponsors and Collaborators

    • Qingdao Central Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qingdao Central Hospital
    ClinicalTrials.gov Identifier:
    NCT05267288
    Other Study ID Numbers:
    • QDCH2022-02-18
    First Posted:
    Mar 4, 2022
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Afatinib

    Study Results

    No Results Posted as of Mar 4, 2022