EGFR-TKI Combined With Concurrent or Sequential Chemotherapy for Patients of Gradual Progression

Phase 2

Completed

• Conditions: Lung Adenocarcinoma; EGFR Activating Mutation
• Interventions: Drug: icotinib combined with pemetrexed plus cisplatin; Drug: first icotinib and then pemetrexed plus cisplatin

• Registration Number: NCT03544814
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

To compare the efficacy of simultaneous EGFR-TKI and chemotherapy with that of sequential treatment after patients gradually progressed from first-line EGFR-TKI treatment.

Patients who had gradual progression and EGFR-T790M mutation-negative were randomly divided into two groups: in concurrent group, patients were treated with pemetrexed plus cisplatin along with the same EGFR-TKI; in sequential group, patients continued with EGFR-TKI until the disease progressed again according to the RECIST criteria, and then switched to chemotherapy. We evaluated progression-free survival (PFS) and overall survival (OS) time of patients. For sequential group, PFS was PFS1 (gradual progression to discontinue EGFR-TKI) plus PFS2 (chemotherapy alone).

Detailed Description

According to previous reports, when non-small cell lung cancer (NSCLC) patients with EGFR mutations gradually progressed after initial EGFR tyrosine-kinase inhibitor (TKI) treatment, continuing TKI therapy may be beneficial. We aimed to compare the efficacy of simultaneous EGFR-TKI and chemotherapy with that of sequential treatment after patients gradually progressed from first-line EGFR-TKI treatment.

Patients who had gradual progression and EGFR-T790M mutation-negative were randomly divided into two groups: in concurrent group, patients were treated with pemetrexed plus cisplatin along with the same EGFR-TKI; in sequential group, patients continued with EGFR-TKI until the disease progressed again according to the RECIST criteria, and then switched to chemotherapy. We evaluated progression-free survival (PFS) and overall survival (OS) time of patients. For sequential group, PFS was PFS1 (gradual progression to discontinue EGFR-TKI) plus PFS2 (chemotherapy alone). Objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety were also evaluated.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-12-30
• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-04
• Last Update Submitted: 2019-10-11
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent therapy group	icotinib combined with pemetrexed plus cisplatin	Icotinib combined with pemetrexed plus cisplatin.
Sequential therapy group	first icotinib and then pemetrexed plus cisplatin	First icotinib and then pemetrexed plus cisplatin.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	16 months	Radiographic assessments were performed when enrolled and every 8 weeks until disease progression after chemotherapy according to RECIST version 1.1. After PD, collect the survival information every 16 weeks until death or withdrawal of study consent.

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	32 months	Radiographic assessments were performed when enrolled and every 8 weeks until disease progression after chemotherapy according to RECIST version 1.1. After PD, collect the survival information every 16 weeks until death or withdrawal of study consent.