Afatinib translational study in patients with EGFR mutation-positive non-squamous non-small cell lung cancer acquired resistance to osimertinib

JRCT ID: jRCTs071180013

Registered date:24/01/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: EGFR mutation-positive non-squamous non-small cell lung cancer
• Date of first enrollment: 16/08/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Afatinib treatment

Outcome(s)

• Primary Outcome: Genetic alterations analysis
• Secondary Outcome: Objective response rate, progression-free survival, time-to-treatment-failure, overall survival, safety

Key inclusion & exclusion criteria

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

Include criteria

1) Pathologically confirmed non-squamous NSCLC
2) Cases of postoperative recurrence or progressive disease (stage IIIB, IIIC or IV)
3) Confirmed EGFR mutation positivity (exon 19 deletion or exon 21 L858R mutation) at the time of receiving 1st line treatment
4) Treated with osimertinib in the 1st line and confirmed to have progressive disease at the time of study enrollment
5) Capability to provide two tubes of whole blood (EDTA-2Na collection tube, in 2 tubes, 8 mL/tube) and tumor tissue (formalin-fixed paraffin-embedded, in 10 slices, 4-5 maicrom thickness each) collected at the time of progressive disease
6) progressive disease within 8 weeks of the study enrollment
7) Measurable disease by RECIST ver. 1.1
8) Age: >20 years
9) ECOG PS: 0 or 1
10) Adequate functions of major organs (e.g. bone marrow, heart, lung, liver, kideney)
11) Life expectancy >90 days at the time of study enrollment
12) Willingness to sign informed consent form

Exclude criteria

1)Complications in lungs such as ILD, COPD, phenmoconiosis, or drug-induced pneumonia that is clinically symptomatic or assessed by chest CT
2)Uncontrollable pleural effusion, ascites, and pericardial effusion
3)Symptomatic brain metastases or cancer-related meningitis. Patients who undergo local treatment of brain metastases and have stable symptoms are permitted to participate in the study
4)History of radiation treatment (including lung) 4 weeks prior to the study enrollment
5)Major surgery within 4 weeks of the study enrollment
6)Having multiple active cancers
7)Active infections that require the treatment with antibiotics, antifungal drugs, and antiviral drugs
8)Serious complications (e.g. GI bleeding, heart disease, glaucoma, diabetes mellitus)
9)History of severe allergy
10)Current continuous treatment with steroids
11)Mental illness judged to be clinical inadequate for enrolling in the study
12)Females who are pregnant, lactating, or have possibility to be pregnant. Females and males who are unwilling to take contraceptives
13)Inappropriate for the study judged by a physician

Related Information

• Primary Sponsor: Ryo Toyozawa
• Source(s) of Monetary Support: Nippon Boehringer Ingelheim Co., Ltd