Continuation of TKI With or Without Chemotherapy Beyond Gradual Progression

Phase 2

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: EGFR tyrosine kinase inhibitor; Drug: EGFR tyrosine kinase inhibitor with chemotherapy

• Registration Number: NCT01998061
• Lead Sponsor: Zhejiang University

Brief Summary

There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.

Detailed Description

We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.

Study Timeline

• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-11-24
• Study First Posted: 2013-11-28
• Status Verified: 2013-12
• Study Start: 2013-12
• Last Update Submitted: 2013-12-19
• Last Update Posted: 2013-12-20
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	EGFR tyrosine kinase inhibitor	TKI alone until rapid progression
Arm B	EGFR tyrosine kinase inhibitor with chemotherapy	TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.

Primary Outcome Measures

Name	Time	Method
Progression free survival	up to 18 months

Secondary Outcome Measures

Name	Time	Method
Objective response rate cacy	up to 18 months

Trial Locations

Locations (1)

Qiong Zhao; 🇨🇳 Hangzhou, Zhejiang, China