NCT02037997

Brief Summary

The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations

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
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2013

Typical duration 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, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

January 2, 2014

Last Update Submit

February 22, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

PFS

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (2)

combination with Erlotinib

EXPERIMENTAL

Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2

Drug: docetaxelDrug: pemetrexedDrug: Erlotinib

sequential chemotherapy for Erlotinib

ACTIVE COMPARATOR

docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd

Drug: docetaxelDrug: pemetrexedDrug: Erlotinib

Interventions

docetaxelDRUG

docetaxel 75mg/m2 ivgtt D1

combination with Erlotinibsequential chemotherapy for Erlotinib
pemetrexedDRUG

pemetrexed 500mg/m2 ivgtt D1

combination with Erlotinibsequential chemotherapy for Erlotinib
ErlotinibDRUG

Erlotinib 150mg qd

combination with Erlotinibsequential chemotherapy for Erlotinib

Eligibility Criteria

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

You may qualify if:

  • Sign the informed consent
  • ≥18 years
  • According to RECIST 1.1 standard, at least one measurable lesions
  • Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
  • Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
  • PS=0,1,2
  • No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
  • Hb≥9g/dL；WBC≥3\*109/L，ANC≥1.5\*109/L，PLT≥75\*109/L
  • Men or women of childbearing age in the experiment are willing to take contraceptive measures
  • Estimated survival period for 3 months or more

You may not qualify if:

  • The palliative chemotherapy ever use docetaxel and pemetrexed
  • small cell lung cancer non small cell hybrid
  • Women during pregnancy or lactation
  • In the past the anti-tumor treatment of any outstanding ease of \> CTCAE 2 levels of toxicity
  • Ccr\<30 ml/min (calculated by Cockcroft-Gault formula)
  • hepatic insufficiency： Tbil\> 1.5×ULN ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN)
  • Severe symptomatic heart disease
  • Symptomatic brain metastases
  • In the last 5 years have been or are suffering from other histological types of malignant tumor
  • There are serious or uncontrolled systemic diseases
  • During the study period planned radiotherapy on target lesion
  • During the study period, plans to use other antineoplastic therapy
  • Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DocetaxelPemetrexedErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicQuinazolines

Study Officials

  • Chang J hua, PD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang J hua, PD

CONTACT

13916619284changjianhua@163.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
attending

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 16, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CN(1)