NCT03374280

Brief Summary

To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

December 11, 2017

Last Update Submit

March 27, 2019

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancerGefitinibEGFR negativePemetrexed

Outcome Measures

Primary Outcomes (1)

  • disease progression-free survival

    the last patient into group for three years or dead

    3 years

Secondary Outcomes (3)

  • overall survival

    5 years

  • side-effects

    3 years

  • overall response rate

    3 years

Study Arms (2)

pemetrexed/cisplatin intercalating gefitinib

EXPERIMENTAL

pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable

Drug: pemetrexed/cisplatin intercalating gefitinib

pemetrexed/cisplatin

ACTIVE COMPARATOR

pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable

Drug: pemetrexed/cisplatin

Interventions

pemetrexed/cisplatin intercalating gefitinibDRUG
pemetrexed/cisplatin intercalating gefitinib
pemetrexed/cisplatinDRUG
pemetrexed/cisplatin

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological diagnosis of small-cll lung cancer histology
  • years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
  • Local stage SCLC without distant metastases
  • After 1st-line chemotherapy (EP or IP) at least 4 cycles
  • After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
  • CR or PR assessment by RECIST(1.0) before randomized
  • Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
  • Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
  • Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

You may not qualify if:

  • Mixed non-small cell lung cancer histology
  • Neck and supraclavicular lymph node metastasis
  • Be allergic to temozolomide or intolerable to radiotherapy
  • Any unstable systemic disease
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jiajia Yu, MD

    the ethics committee of the first affiliated hospital of Guangzhou MC

    STUDY DIRECTOR

Central Study Contacts

Hailing Yang, MD

CONTACT

00862083062825bjrf2009@yahoo.com

Fengnan Wang, MD

CONTACT

00862083062825wangfengnan@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 15, 2017

Study Start

December 1, 2016

Primary Completion

December 30, 2019

Study Completion

December 30, 2021

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

CN(1)