Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance

Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance - BAGEL study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013586

Enrollment

Registered

2014-05-12

Start date

2014-05-23

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

gefitinib gefitinib plus bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with lung cancer which was pathologically proven non-squamous non small cell lung cancer 2) harboring activating mutation of EGFR gene (exon 19 delation, and L858R) 3) advanced (stage IIIB who can not treat radiation therapy, and stage IV) or reccurent NSCLC patients 4) No prior chemotherapy or EGFR-TKI 5) 20 years old or more 6) ECOG PS 0-2 7) Measureable region evaluable 8) Sufficient organ function 9) over 3 months of lifetime expectancy 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of drug induced interstitial pneumonia or radiation pneumonitis that need steroid therapy. Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT 2) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) 3) central nervous system metastases 4) spinal cord compression 5) Active concomitant malignancy 6) Currently have or have a history of hemoptysis 7) bleeding tendency (coagulation disorder) 8) Patients receiving therapeutic anticoagulation 9) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management) 10) History of gastrointestinal perforation 11) History of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; active gastrointestinal ulcer, acive psychological disorders 12) Clinically significant drug allergy 13) Serious concomitant active infection 14) Receiving systemic corticosteroid therapy within 2 weeks of registration 15) Major surgery within 3 weeks of registration, radiotherapy within 2 weeks of registration 16) Pregnant or breast-feeding woman 17) Not suitable for participating in the study for any other reason

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival, Response rate, Disease control rate, Toxicity	—

Countries

Japan

Contacts

Public ContactChiyoe Kitagawa

National Hospital Organization Nagoya Medical Center Department of medical oncology & Respiratory Medicine

kitagawc@nnh.hosp.go.jp052-951-1111

Outcome results

None listed

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