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

JRCT ID: jRCTs051180205

Registered date:27/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung caner
• Date of first enrollment: 15/01/2018
• Target sample size: 26
• Study type: Interventional
• Intervention(s): Oral daily AFA 30-40 mg QD plus BEV (15 mg/kg, day 1) every 3 weeks is administered until progression.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Response rate, overall survival, disease control rate, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hata Akito
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co.,Ltd.,Takarazuka City Hospital,Kobe City Medical Center General Hospital
• Secondary ID(s): UMIN000030545