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

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-jRCTs051180009
• Lead Sponsor: Hayashi Hidetoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified