A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201

A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201 - Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007475

Enrollment

Registered

2012-03-09

Start date

2012-03-01

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-squamous non-small cell lung cancer

Interventions

Erlotinib Erlotinib + Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small lung cancer 2)history of 2 courses or more bevacizumab plus platinum doublet 3)known no active EGFR gene mutation 4)20 years or older 5)PS:0-2 (ECOG) 6)at least one measurable leision (RECIST) 7)patients who has the following periods *the last prior chemotherapy:3weeks *palliative radiotherapy(ex thorax):2weeks *operation:4 weeks *chest drainage:1weeks *biopsy with incision, port custody,and treatment to injury:2weeks 8)adequate bone marrow,liver,and renal functions 9)a life expectancy of 3 months or more 10)written informed consent

Exclusion criteria

Exclusion criteria: 1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known active EGFR gene mutation 3)history of erlotinib or gefitinib treatment 4)inable of oral drug administration 5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 6)Risk of hemoptysis patients after thoracic radiation therapy is expected 7)With great vessel invasion 8)1cm or longer cavity in tumor 9)current or previous (within the last 1 year)history of GI perforation 10)history of myocardial infarction and cerebral infarction 11)planned surgery within study term 12)uncontrolled heypertension 13)symptomatic brain metastasis 14)history of drug allergy 15)massive,pleural effusion or ascites 16)uncontrolled infection or serious medical complications 17)active concomitant malignancy 18)mental disorder 19)pregnant or or lactating women or those who declined contraception 20)those judged not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression Free Survival at 3 months after randomized	—

Secondary

Measure	Time frame
Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival, Safety	—

Countries

Japan

Contacts

Public ContactShunichi Sugawara

Sendai Kousei Hospital Department of Respiratory Medicine

swara357@cat-v.ne.jp022-222-6181

Outcome results

None listed

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