A prospective, phase II trial of low-dose afatinib monotherapy for patients with EGFR, mutation-positive, non-small cell lung cancer(TORG1632).

A prospective, phase II trial of low-dose afatinib monotherapy for patients with EGFR, mutation-positive, non-small cell lung cancer(TORG1632). - Low-dose afatinib phase II study patients with EGFR Mutation-positive NSCLC(TORG1632)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027338

Enrollment

Registered

2017-05-15

Start date

2017-05-15

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

Afatinib is prescribed at 20mg/day daily If SD or =&lt

AE Grade1, this dose can be increased after 8 weeks of treatment, and repeated up to 50mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologicaly or cytologically confirmed Stage IV or recurrent non-small cell lung cancer 2)Harboring sensitive EGFR mutation(Exon 19 deletion,L858R) 3)No prior chemotherapy and EGFR-TKI 4)Measurable disease for RECIST ver.1.1 5)Aged equal and more than 20 years old. 6)ECOG PS 0-2 7)Life expectancy: more than 3 months 8)Informed consent 9)Adequate organ functions judged by laboratory tests i.ANC >= 1,500 mm3 ii.Hb >= 9.0g/dl iii.PLT >= 75,000 mm3 iv.T-bil < 1.5 mg/dl v.AST < 100 IU/L vi.ALT< 100 IU/L vii.SpO2 >= 93 %

Exclusion criteria

Exclusion criteria: 1)Prior chemotherapy, GFR-TKI, biological drug and any investigational drug within 4 weeks. 2)Prior hormone therapy within 2 weeks. 3)Patients received radiotherapy for primary region and/or evaluable region. 4)Patients with major operation history within 4 weeks or planned during treatment period/ 5) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography 6)Symptomatic brain metastases 7)Uncontrolled complications 8)Treatment needed infection 9)Patients with hepatic cirrhosis or HIV 10)Patients with active double cancer less than 5 years 11)Patients with significant malabsorption syndrome 12)Pregnancy, breastfeeding or suspected of being pregnant 13)Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons 14)Patients with a history of allergy for a component of afatinib

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
-Response rate -Disease control rate -One-year PFS rate -Overall survival -Time to treatment failure -AE rate	—

Countries

Japan

Contacts

Public ContactRintaro Noro

Graduate School of Medicine, Nippon Medical School, Nihon Medical School Hospital Department of Pulmonary Medicine and Oncology

r-noro@nms.ac.jp03-3822-2131

Outcome results

None listed

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