A phase II study of Cisplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

A phase II study of Cisplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR - A phase II study of Cisplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012215

Enrollment

Registered

2013-11-05

Start date

2013-04-01

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

Non-small cell lung cancer(Non squamous)

Interventions

Cisplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.EGFR-TKI continue until PD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically or cytologically confirmed non-squamous NSCLC with activating EGFR-mutations 2. no previous chemotherapy 3. Stage IIIB, VI 4. measurable disease 5. 75>age >=20 years 6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale 7. adequate organ function adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =90%, Proteinuria< 1+ 8. PD after EGFR-TKI treatment more than 6 month

Exclusion criteria

Exclusion criteria: 1. Medication with anti-coagulative 2.Active infection or other serious conditions 3. Severe pleural effusion or uncontrollable pleural effusion 4.Symptomatic brain metastasis 5. Uncontrollable hypertension 6. Uncontrollable diabetes mellitus 7. Current or previous history of hemoptysis or hemosputum 8. Current or previous (within the last 1 year) history of GI perforation 9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 10.Tumor invasive to the chest large blood vessel. 11.Evidence of bleeding diathesis or coagulopathy 12.History of active double cancer 13.History of active psychological disease 14.History of pregnancy or lactation 15. Active concomitant malignancy 16. Active mental illness 17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab 18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
PFS,OS,Beyond PD lesion Response Rate: BPRR	—

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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