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Completed

NCT Number: NCT00864266

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

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.

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Key information

Conditions

Non Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pneumology Clinique Saint-Luc, Bouge, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chemotherapy

Drug

Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Primary outcomes

  1. Response rate

    Time frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria

Secondary outcomes

  1. Survival

    Time frame: Survival will be dated from the date of treatment

  2. Progression-free survival

    Time frame: Period between the date of treatment and the date of first progression or death

  3. Duration of response

    Time frame: period between the day of treatment and the date of first progression in patients with an objective response

Sponsors and collaborators

Lead sponsor

European Lung Cancer Working Party

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2009
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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