Afa+Bev for EGFR mutant NSCLC

Phase 2

• Conditions: on-squamous non-small cell lung cancer

• Registration Number: JPRN-jRCTs061180006
• Lead Sponsor: Kiura Katsuyuki

Brief Summary

Compared with afatinib monotherapy, afatinib plus bevacizumab did not prolong the PFS of untreated patients with EGFR-mutated non-squamous NSCLC.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-19
• Study Completion: 2021-09-02
• Results First Posted: 2023-08-19
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

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 syndrome, interstitial pneumonia etc.)
11) History of serious drug allergies
12) Pregnancy, breast feeding, or hesitation in contraception
13) Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival, Response rate, Disease control rate, Progression disease rate, Time to treatment failure