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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
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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

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Response Rate (RR) [ Time Frame: 2 months ]
  2. Overall Survival (OS) [ Time Frame: 6 months ]
  3. Adverse Event (AE) [ Time Frame: 2 months ]
    NCI CTC 4.03


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