NCT02886195

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2016

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

August 2, 2016

Last Update Submit

August 27, 2016

Conditions

EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    6 months

Secondary Outcomes (3)

  • Response Rate (RR)

    2 months

  • Overall Survival (OS)

    6 months

  • Adverse Event (AE)

    2 months

Study Arms (3)

PC plus erlotinib

EXPERIMENTAL

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: pemetrexedDrug: cisplatinDrug: Erlotinib

erlotinib

ACTIVE COMPARATOR

erlotinib 150mg/d until "progress disease"

Drug: Erlotinib

PC

ACTIVE COMPARATOR

pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles

Drug: pemetrexedDrug: cisplatin

Interventions

pemetrexedDRUG

500mg/m2 ivgtt d1, per three weeks

PCPC plus erlotinib
cisplatinDRUG

80mg/m2 ivgtt d1, per three weeks

PCPC plus erlotinib
ErlotinibDRUG

150mg po. every day

PC plus erlotiniberlotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • EGFR mutation-negative
  • Previous systemic antitumour treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lin J, Li M, Chen S, Weng L, He Z. Efficacy and Safety of First-Generation EGFR-TKIs Combined with Chemotherapy for Treatment-Naive 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.

    PMID: 34168480DERIVED

MeSH Terms

Interventions

PemetrexedCisplatinErlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsQuinazolines

Study Officials

  • zhiyong he he, master

    Fujian province cancer hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

September 1, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 1, 2016

Record last verified: 2016-07