A randomized phase II study of the efficacy and safety of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy.

A randomized phase II study of the efficacy and safety of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy. - A randomized phase II study of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in elderly NSCLC who received Bevacizumab / Pemetrexed induction therapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013122

Enrollment

Registered

2014-02-10

Start date

2014-02-10

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

Pemetrexed Bevacizumab Pemetrexed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)stageIII/IV or recurrent post-operative non-squamous and non-small cell lung cancer 3) No prior use of chemotherapy 4)PS:0-1 (ECOG) 5)at least one measurable leision (RECIST) 6)Patients aged 75 or over 7)adequate bone marrow,liver,and renal functions 8)patients who has the following periods *radiotherapy:2weeks *operation(surgery with lobectomy):8 weeks *operation(surgery without lobectomy):4weeks *pleurodesis,chest drainage:2weeks 9)written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with symptomatic Brain metastasis 2)History of hemoptysis 3)History of thoracic radiotherapy 4)active infection 5)fever 6)severe complication 7)massive pleural effusion or ascites 8)active concomitant malignancy 9)history of severe drug allergy 10)uncontrolled peptic ulcer 11)Current or previous history of GI perforation 12)Patients with therapeutic anticoagulopathy 13)those judged not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response rate, Disease control rate, Overall survival, Adverse event rate	—

Countries

Japan

Contacts

Public ContactTetsuo Tani

School of Medicine, Keio University, Tokyo, Japan Department of Pulmonary Medicine

t.tani@z3.keio.jp0333531211

Outcome results

None listed

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