A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer

A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer - A phase I/II study of Bevacizumab combined with Cisplatin and Pemetrexed for Patients with Non-Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004118

Enrollment

Registered

2010-08-27

Start date

2014-09-03

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-squamous non-small-cell lung cancer

Interventions

Cislpatin (75mg/m2 day1) + Pemetrexed(500mg/m2 day1) + Bevacizumb (15mg/kg day1) q3weeks 4(-6)cycles followed by Bevacizumab (15mg/kg day1)q3weeks until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer 2) Stage III/IV without indication for curative resection and post-operative recurrent disease 3) Patients aged 20-74 years 4) ECOG performance status 0-1 5) Target lesion is measurable(RECISTver1.1) 6) Chemotherapy naive 7) Excepted to live over 3 months after administration day 8) More than 2 months rest period after radiation 9) Adequate organ function 10) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1) squamous cell carcinoma 2) Patients unable to take or unsupplied with folic acid and vitamin B12 3) History of grave drug allergic react 4) current or previous histoty of hemoptysis (2.5ml) due to NSCLC 5) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 6) Brain metastases with neurological symptoms 7) Pleural effusion, pericardial effusion and ascites to need treatment 8) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment 9) Uncontrollable diabetes mellitus and hypertenson 10) severe cardiac disease 11) Current or previous history of cerebrovascular disease 12) Current of amalgamated venous thromboembolism 13) Uncontrollable infectious disease 14) current or previous (within the last 1 year) history of GI perforation 15) Traumatic fracture of unrecovery 16) active concomitant malignancy 17) Thoracic radiotherapy has been scheduled for the examination period 18) Surgical procedure within 28 days before registration 19) history of pregnancy or lactation 20) No intention to practice birth control 21) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

Measure	Time frame
STEP1 Safety STEP2 Overall Response Rate	—

Secondary

Measure	Time frame
Progression-free survival (PFS) Overall Survival Overall Response Rate for combination CT Adverse events	—

Countries

Japan

Contacts

Public Contactkazuhito Funai

Hamamatsu University School of Medicine First Department of Surgery

kfunai@hama-med.ac.jp053-435-2276

Outcome results

None listed

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