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Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation

Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation - Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016029
Enrollment
20
Registered
2014-12-22
Start date
2015-01-05
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

Combination therapy of afatinib + bevacizumab

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Harboring sensitive EGFR mutation 3)Stage IIIB, IV, relapse post operation and no indication for operation and curative irradiation 4)Having measurable disease for RECIST ver. 1.1 5)More than 20 years old and less than 75 years old 6)Performance status: 0-1 7)Life expectancy: over 90 days 8)Adequate organ functions 9)PaO2 >= 70torr or SpO2 >= 95% at room air 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Interstitial pneumonitis on chest CT 3)Symptomatic brain metastases 4)Uncontrollable pleural effusion or pericardial effusion 5)Having hemoptysis 6)Having risk factor of bleeding 7)Gastrointestinal ulcer or past history of gastrointestinal perforation 8)Uncontrollable hyper tension 9)Active infectious disease 10)Receiving steroids or immunosuppressants 11)Receiving consecutive oxygen therapy 12)Inadequate period from open surgery 13)Planning open surgery 14)Pregnant or breastfeeding woman 15)History of severe allergy 16)Having other severe complications 17)Patients whose physicians considered as inappropriate for this clinical study

Design outcomes

Primary

MeasureTime frame
To conclude maximum tolerated dose and recommended phase II dose.

Countries

Japan

Contacts

Public ContactRyo Ko, Takehito Shukuya

Juntendo University Department of Respiratory Medicine

rkou@juntendo.ac.jp03-5802-1062

Outcome results

None listed

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