NCT04257864

Brief Summary

To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Status
completed

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

November 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

February 4, 2020

Last Update Submit

February 6, 2020

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor response

    Evaluation of response using RECIST 1.1 criteria (REF) was based on the measurement of a total of 5 measurable lesions.

    Every 12 -16 weeks

Study Arms (3)

Erlotinib followed by docetaxel

Erlotinib given for twelve consecutive days before docetaxel

Docetaxel followed by erlotinib

Erlotinib given for twelve consecutive days after docetaxel

Bevacizumab treated

Bevacizumab treated patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with non small cell lung cancer evaluated with Computed Scan or Magnetic Resonance Imaging.

You may qualify if:

  • Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).

You may not qualify if:

  • \. Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

November 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2014

Last Updated

February 10, 2020

Record last verified: 2020-02