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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non small cell lung carcinoma, Chemotherapy, Response prediction