EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC (effect)

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ClinicalTrials.gov Identifier: NCT02886195

Recruitment Status : Unknown

Verified July 2016 by Fujian Cancer Hospital.
Recruitment status was: Enrolling by invitation

First Posted : September 1, 2016

Last Update Posted : September 1, 2016

Sponsor:

Information provided by (Responsible Party):

Fujian Cancer Hospital

Study Description

Brief Summary:

The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).

Condition or disease	Intervention/treatment	Phase
EGFR Gene Mutation	Drug: pemetrexed Drug: cisplatin Drug: Erlotinib	Phase 3

Detailed Description:

This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).

Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.

The endpoint of this study included clinical efficacy and safety.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
Study Start Date :	July 2016
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PC plus erlotinib pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy	Drug: pemetrexed 500mg/m2 ivgtt d1, per three weeks Drug: cisplatin 80mg/m2 ivgtt d1, per three weeks Drug: Erlotinib 150mg po. every day
Active Comparator: erlotinib erlotinib 150mg/d until "progress disease"	Drug: Erlotinib 150mg po. every day
Active Comparator: PC pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles	Drug: pemetrexed 500mg/m2 ivgtt d1, per three weeks Drug: cisplatin 80mg/m2 ivgtt d1, per three weeks

Outcome Measures

Primary Outcome Measures :

Progression-Free Survival (PFS) [ Time Frame: 6 months ]

Secondary Outcome Measures :

Response Rate (RR) [ Time Frame: 2 months ]
Overall Survival (OS) [ Time Frame: 6 months ]
Adverse Event (AE) [ Time Frame: 2 months ]
NCI CTC 4.03

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage Ⅳ EGFR mutation-positive NSCLC
Initial therapy
ECOG performance status 0-1

Exclusion Criteria:

EGFR mutation-negative
Previous systemic antitumour treatment

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886195

Sponsors and Collaborators

Fujian Cancer Hospital

Investigators

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Study Chair:	zhiyong he he, master	Fujian province cancer hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lin J, Li M, Chen S, Weng L, He Z. Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naïve Advanced Non-Small-Cell Lung Cancer Patients Harboring Sensitive EGFR Mutations: A Single-Center, Open-Label, Single-Arm, Phase II Clinical Trial. J Inflamm Res. 2021 Jun 16;14:2557-2567. doi: 10.2147/JIR.S313056. eCollection 2021.

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Responsible Party:	Fujian Cancer Hospital
ClinicalTrials.gov Identifier:	NCT02886195
Other Study ID Numbers:	secgolc001
First Posted:	September 1, 2016 Key Record Dates
Last Update Posted:	September 1, 2016
Last Verified:	July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	Depending on the process of the study

Additional relevant MeSH terms:

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Pemetrexed Erlotinib Hydrochloride Antineoplastic Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors

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