Trial of the alternative therapy with osimeritinib and afatinib for NSCLC with EGFR mutation (Alt trial) (WJOG10818L)

JRCT ID: jRCTs051180009

Registered date:26/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 28/11/2018
• Target sample size: 40
• Study type: Interventional

Intervention(s)

A: Osimertinib
Dose: 80mg/day, orally once per day for 8 weeks
B: Afatinib
Dose: 20mg/day, orally once per day.
Repeat A and B until PD.

Outcome(s)

• Primary Outcome: One-year progression-free survival (PFS) rate.
• Secondary Outcome: PFS, overall survival (OS), overall response rate (ORR), safety, Duration of period until initiation of cytotoxic chemotherapy, PFS, OS, and ORR by EGFR mutation subtype (exon19del or L858R).

Key inclusion & exclusion criteria

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

Include criteria

1. Able to understand and give written informed consent and comply with study procedures.
2. Pathologically confirmed diagnosis of non-squamous non-small cell lung carcinoma.
3. The patients that EGFR mutations was confirmed by the routine EGFR test (exon 19 deletion or exon 21 L858R substitution)
4. Confirmed diagnosis of stage IIIB, IIIC (not amenable for curative intent local radiotherapy) / IV (recurrent or metastatic).
5. Measurerable disease per RECIST guidelines ver 1.1
6. Eastern Cooperative oncology Group (ECOG) performance status 0 or 1.
7. Age >/= 20 years.
8. Adequate organ function
9. No prior systemic chemotherapy including EGFR-TKIs and immune-checkpoint inhibitors.
10. No symptomatic brain metastasis.

Exclude criteria

1. Multiple primary cancers.
2. Serious active infections.
3. Active Hepatitis A or B.
4. Known history of stroke or cerebrovascular accident within 1 year prior to the enrollment.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure, or serious arrhythmias requiring medication for treatment.
6. Evidence of interstitial pneumonia, drug induced pneumonitis or radiation pneumonitis on chest CT scan.

Related Information

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