Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer

Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer - Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005917

Enrollment

Registered

2011-07-04

Start date

2011-06-01

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

Stage IV EGFR mutation positive non-small-cell lung cancer patients

Interventions

Pemetrexed/Cisplatin/Bevcizumab+EGFR-TKIs followed by Pemetrexed/Bevacizumab+EGFR-TKIs until progression disease

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)EGFR mutations in the tumor specimens 2)Stage IV non-small cell lung cancer proven by histology 3)No prior chemotherapy 4)Tumors that could be measurable by RECIST 5)Age 20 to 75 years 6)ECOG performance status of 0-1 7)No severe impairment of major organs, laboratory data within 14 days Neutrophil &#8805; 2,000/mm3 Platelet &#8805; 100,000/mm3 Hemoglobin &#8805; 9.0 g/dl AST and ALT &#8805; 2.5 ULN T-Bil &#8805; 1.5 ULN Albumin &#8805; 2.5 g/dl Cre &#8805; 1.5 mg/dl Cr &#8805; 45 ml/min SpO2(Room air) &#8805; 92% 8)A life expectancy of more than 90 days 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Squamous Cell Carcinoma 2)Interstitial pneumonia or pulmonary fibrosis on Chest Xray 3)Superior vena cava syndrome 4)Renal dysfunction 5)Patients with superior vena cava syndrome 6)Central nervous system metastases 7)Other active malignancy 8)Uncontrollable hypertension, uncontrollable diabetes 9)Patients who are diagnosed as cirrhosis with image orclinical examination 10)Heart disease as follows; unstable angina, myocardial infarction within 6 months, post-PTCA or post-CAGB, congestive heart failure, arrhythmia requiring treatment 11)Pregnancy, lactation or no intention to practice birth control 12)Sever drug allergy 13)Acute inflammatory disease 14)No consent to blood transfusion or other supportive care 15)With a clinical bleeding tendency 16)History of sever hemoptysis or bloody sputum 17)Cavity lesion

Design outcomes

Primary

Measure	Time frame
Treatment completion rate of induction therapy	—

Secondary

Measure	Time frame
Response Rate Disease Controle Rate Pprogression-Free-Survival 1-year Survival Rate Safety Overall Survival	—

Countries

Japan

Contacts

Public ContactYoshinobu Iwasaki

Kyoto Prefectural University of Medicine Pulmonary Medicine

yiwasaki@kyoto.kpu-m.ac.jp

Outcome results

None listed

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