A phase 2 study of afatinib for NSCLC with uncommon EGFR mutation detected by NGS

A phase 2 study of afatinib for advanced non-small cell lung cancer with uncommon epidermal growth factor receptor (EGFR) mutation including compound mutation detected by next generation sequencing

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041190027

Enrollment

Registered

2019-05-20

Start date

2020-01-10

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 with uncommon EGFR mutaiton

Interventions

Afatinib Dose: 40mg/day, orally once per day, until progression disease (or the meeting of discontinuation criteria)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Non-small cell lung cancer proven by histology and/or cytology 2) Confirmed diagnosis of stage III (not amenable for curative intent local radiotherapy), IV or postoperative/post chemoradiation therapy recurrence 3) single or compound uncommon EGFR mutaion detected by NGS with the exclusion of T790M mutaion or exon 20 insertion 4) 20 years or older 5) ECOG PS 0 or 1 6) No prior treatment with EGFR-TKI 7) At least one or more measurable lesion by RECIST 8) Adequate organ function 9) Written informed consent for translational research Written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with resistance EGFR mutations (T790M mutaion or exon 20 insertion) 2) Severe active infections 3) Severe diarrhea 4) Evidence of interstitial desease such as Idiopathic pulmonary fibrosis, pneumoconiosis and drug-induced pneumonitis 5) Patients unable to swallow oral medications 6) Under treatment of high-dose steroid therapy or immunosuppressive therapy 7) History of allergic reaction Decision of ineligibility by a physician 8) Prior treatment withimmune-checkpoint inhibitors within 3 months 9) Symptomatic brain metastasis/ leptomeningitis 10) Uncontrollable pleural, peritoneal or pericardial effusion 11) Prior palliative radiotherapy within 1weeks 12) Uncontrolled or severe hypertention, diabetes mellitus, active bleeding of the digestive tract, and known history of cardiovascular disease including congestive heart failure, myocardial infarction or unstable angina within 6 months. 13) No intention to birth control

Design outcomes

Primary

Measure	Time frame
Objective responce rate (ORR)	—

Secondary

Measure	Time frame
Progression free survival (PFS), Overall survival (OS), safety	—

Contacts

Public ContactNobuaki Mamesaya

Shizuoka cancer center

n.mamesaya@scchr.jp+81-55-989-5222

Outcome results

None listed

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