Afatinib Plus Bevacizumab After Osimertinib Failure(ABCD-study/ HANSHIN Oncology Group 0217 trial))

Phase 2

• Conditions: ung caner; Lung cancer

• Registration Number: JPRN-jRCTs051180205
• Lead Sponsor: Hata Akito

Brief Summary

Afatinib + bevacizmab after Osimertinib resistance demonstrated moderate efficacy and favorable safety. - A small portion of C797S patients exhibited sensitivity. - Higher potency was suggested in T790M/BRAF/KRAS/PI3K mutation-negative and uncommon EGFR/HER2 mutation positive patients. - Selected population could obtain clinical benefit from Afatinib + bevacizmab, based on rebiopsy results after Osimertinib resistance.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2021-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1) Histologically or cytologically proven non-small cell lung cancer
2) EGFR-mutant
3) After osimertinib failure (after CR/PR or SD longer than 6 months)
4) Blood samples after osimertinib failure are available.
5) 4 weeks has passed since completion of thoracic radiation
6) Aged more than 20
7) ECOG PS 0 or 1
8) With evaluable lesions by RECIST
9) Adequate organ functions
10) Life expectancy longer than 3 months
11) Written informed consent

Exclusion Criteria

1) Interstitial lung disease or pulmonary fibrosis by chest CT
2) Symptomatic CNS metastases
3) History of severe allergy
4) Severe infection of comorbidities
5) Uncontrolled pleural, abdominal, and/or cardiac effesion
6) Severe heart disease
7) Uncontrolled hypertension
8) Uncontrolled diabetes
9) Active double cancer
10) Squamous histology
11) Severe mental illness
12) Massive hemoptysis
13) History of GI perfolation
14) Incurable bone fracture
15) Planning surgery during the trial
16) Bleeding tendecy
17) Uncontrolled thromboembolizm
18) Receiving EGFR-TKIs or immunotherapies after osimertinib failure
19) Pregnant women
20) unproper patients for the clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified