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

Phase 2 clinical trial of the alternative therapy with osimertinib and afatinib for treatment-naive advanced NSCLC with EGFR mutation. (Alt trial) (WJOG10818L) - Alt trial (WJOG10818L)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051180009

Enrollment

Registered

2018-11-26

Start date

2018-11-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
One-year progression-free survival (PFS) rate.	—

Secondary

Measure	Time frame
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).	—

Contacts

Public ContactHidetoshi Hayashi

Kindai University Hospital, Department of Medical Oncology

hidet31@med.kindai.ac.jp+81-72-366-0221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026