Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

June 25, 2020 updated by: European Lung Cancer Working Party

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bouge, Belgium, 5004
        • Department of Pneumology Clinique Saint-Luc
      • Brussels, Belgium, 1000
        • Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Service de Pneumologie Hôpital Erasme
      • Gilly, Belgium, 6060
        • Department of Pneumology Hôpital Saint-Joseph
      • Mons, Belgium, 7000
        • Hopital Ambroise Pare
      • Mouscron, Belgium, 7700
        • Department of Pneumology Centre Hospitalier de Mouscron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological diagnosis of non-small-cell lung cancer (NSCLC)
  • Obtention of a biopsy of the tumour according to the procedure defined in the protocol
  • NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
  • Presence of at least one assessable lesion
  • Availability for participating in the detailed follow-up of the protocol
  • Signed informed consent.
  • Age above 18 years

Exclusion Criteria:

  • Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
  • NSCLC treated by exclusive surgery or radiotherapy
  • A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)
Drug: Chemotherapy
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria
response will be assessed every 3 cycles of chemotherapy according to WHO criteria

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: Survival will be dated from the date of treatment
Survival will be dated from the date of treatment
Progression-free survival
Time Frame: Period between the date of treatment and the date of first progression or death
Period between the date of treatment and the date of first progression or death
Duration of response
Time Frame: period between the day of treatment and the date of first progression in patients with an objective response
period between the day of treatment and the date of first progression in patients with an objective response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Lung Cancer Working Party

Investigators

  • Study Chair: Thierry Berghmans, MD, European Lung Cancer Working Party

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Actual)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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