Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer

Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer - Exploratory clinical study of first-line treatment for patients with advanced EGFR mutation-positive non-squamous non-small-cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015414

Enrollment

Registered

2014-10-11

Start date

2014-10-20

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

advanced EGFR mutation-positive non-squamous non-small cell lung cancer

Interventions

EGFR-TKI monotherapy (gefitinib, erlotinib or afatinib) maintenance therpy of gefitinib plus pemetrexed after gefitinib, carboplatin plus pemetrexed concurrent therapy erlotinib plus bevacizumab thera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Cytologically or histologically documented non-squamous non-small cell lung cancer 2.EGFR activating mutation positive 3.Stage III without any indications for radiotherapy, Stage IV, or postoperative recurrence 4.chemotherapy naive 5.Prior palliative radiotherapy 1)Except to the primary pulmonary lesion 2)more than two weeks after palliative radiotherapy for bone metastasis 6.Evaluable lesions (Measuarable lesions are not necessary) 7.20 years of age or older at the time of consent 8.ECOG PS 0-1 9.Have adequate organ function within two weeks before study entry 10.Have signed an informed consent 11.Estimated life expectancy of at least 3 months

Exclusion criteria

Exclusion criteria: 1.EGFR mutation Exon20 T790M positive 2.Symptomatic brain metastasis and a spinal metastases requiring surgical treatment or irradiation 3.Less than 5 years of disease-free interval with other malignancy 4.Pleural effusion, ascites or pericardial fluid in need of treatment 5.SVC syndrome 6.Spinal cord compression with symptoms 7.Cerebrovascular disorder with aymptoms 8.Unhealed fracture 9.Severe infection 10.Planned surgery during the study period 11.Obvious interstitial lung disease 12.Severe gastrointestinal disorder 13.Symptomatic corneal disease 14.Severe cardiac disease 15.Clinically significant drug allergy 16.Prior EGFR-TKI therapy 17.During pregnabcy or lactating woman 18.Uncontrolled psychiatric disease 19.Other

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Overall survival, Response rate, Adverse events, QOL	—

Countries

Japan

Contacts

Public ContactKazumi Nishino

Osaka Medical Center for Cardiovascular diseases Department of Thoracic Oncology

nisino-ka@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

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