Afa+Bev for EGFR mutant NSCLC

JRCT ID: jRCTs061180006

Registered date:19/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-squamous non-small cell lung cancer
• Date of first enrollment: 26/08/2017
• Target sample size: 100
• Study type: Interventional

Intervention(s)

afatinib 30 mg/day and bevacizumab 15 mg/kg every 3 weeks, until disease progression or unacceptable toxicity
afatinib 40 mg/day, until disease progression or unacceptable toxicity

Outcome(s)

• Primary Outcome: progression free survival
• Secondary Outcome: Overall survival, Response rate, Disease control rate, Progression disease rate, Time to treatment failure

Key inclusion & exclusion criteria

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

Include criteria

1) Non-squamous non-small cell lung cancer
2) EGFR exon19 deletion or L858R
3) stage IIIB or IV or recurrence
4) chemotherapy naive
5) ECOG PS 0 or 1
6) With measurable target lesion or unmeasurable lesion as per RECIST ver1.1
7) With adequate organ function
8) Provided written informed consent

Exclude criteria

1) EGFR exon20 T790M
2) Symptomatic brain metastasis
3) Meningitis
4) Other cancers
5) Hemoptysis
6) Hemorrhagic tendency (coagulation disorder etc.)
7) Invasion to measure artery or vessel
8) Invasion to mucosa of bronchus
9) Pleural effusion, ascites or pericardial effusion requiring drainage
10) With severe complication (SVC syndrome, interstitial pneumonia etc.)
11) History of serious drug allergies
12) Pregnancy, breast feeding, or hesitation in contraception
13) Other conditions not suitable for this study

Related Information

• Primary Sponsor: Kiura Katsuyuki
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd.,Nippon Boehringer Ingelheim Co., Ltd.,Nippon Boehringer Ingelheim Co., Ltd.
• Secondary ID(s): UMIN000027432