Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II study

Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II study - Afatinib vs Afatinib+Bevacizumab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027432

Enrollment

100

Registered

2017-06-18

Start date

2017-06-20

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

afatinib 30 mg/day and bevacizumab 15 mg/kg every 3 weeks, until disease progression or unacceptable toxicity afatinib 40 mg/day, until disease progression or unacceptable toxicity

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Non-squamous non-small cell lung cancer 2) EGFR exon19 deletion or L858R 3) stage IIIB or IV or recurrence 4) chemotherapy naive 5) ECOG PS 0 or 1 6) With measurable target lesion or unmeasurable lesion as per RECIST ver1.1 7) With adequate organ function 8) Provided written informed consent

Exclusion criteria

Exclusion criteria: 1) EGFR exon20 T790M 2) Symptomatic brain metastasis 3) Meningitis 4) Other cancers 5) Hemoptysis 6) Hemorrhagic tendency (coagulation disorder etc.) 7) Invasion to measure artery or vessel 8) Invasion to mucosa of bronchus 9) Pleural effusion, ascites or pericardial effusion requiring drainage 10) With severe complication (SVC symdrome, interstinal neumonia etc.) 11) History of serious drug allergies 12) Pregnancy, breast feeding, or hesitation in contraception 13) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
Overall survival, Response rate, Disease control rate, Relative dose intensity, Quality of life, Adverse events	—

Countries

Japan

Contacts

Public ContactTakashi Ninomiya

Okayama University Hospital Department of Respiratory Medicine and Allergy

tninomiya5@okayama-u.ac.jp086-235-7227

Outcome results

None listed

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