Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201)

Phase II study of Pemetrexed and Bevacizumab in Plutinum Unfit patients with untreated advanced non-squamous non-small cell lung cancer(OSAKA-LCSG1201) - OSAKA-LCSG1201

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009539

Enrollment

Registered

2012-12-13

Start date

2012-10-01

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

Interventions

Pemetrexed Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer (2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (3) Patient who unfit platinum (4)Age 20=< (5)ECOG performance status of 0 to 2 (6)With one or more measurable disease based on RECIST (7) Interval -Immune therapy, Endocrine therapy >3wks -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage>1wks -biopsy with dissection, indwelling port >2wks -blood transfusion >2wks (8)Adequate organ function, evaluated within 14 days before enrollment as Neu >= 1,500 /mm3 Plt >= 10.0 x 10000 /mm3 hemoglobin >= 9.0 g/dL T-bil =< 1.5 mg/dL AST (GOT) ,ALT (GPT) =< 100 IU/L Cr >= 1.5mg/dL Proteinuria <1+ SpO2 >= 90% (9)Expected to live over 3 months after administration days. (10)Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: (1)Symptomatic brain metastasis (2) Have another active malignancy (3) Current or previous history of hemoptysis (4) Evidence of tumor invading large vessel on imaging (5) Evidence of tumor invading trachea or main bronchus on imaging (6) Have received radiation therapy to lesions of lung (7) Currently have or have a history of a cardiac effusion which requires treatment (8) Brain infarction within 1 year (9) Problematic infection (10) Scheduled operation (11) Active radiation pneumonitis or esophagitis (13) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy (14) Decision of ineligibility by a physician.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival, 1 year survival rate, Frequency and grade of adverse event	—

Countries

Japan

Contacts

Public ContactMasayoshi Higashiguchi

Osaka University Hospital Dept. of Respiratory Medicine

higashiguchi@imed3.med.osaka-u.ac.jp06-6879-3833

Outcome results

None listed

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