Advanced Solid Tumor, Non Small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, EGFR detection, liquid biopsy
Brief summary
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
Detailed description
This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing). Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.
Interventions
DIAGNOSTIC_TESTEGFR gene mutation analysis on liquid biopsy
Blood samples will be collected at inclusion for plasma DNA collection and analysis.
Sponsors
Institut Bergonié
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged ≥ 18 years at time of proposal study, 2. Histologically confirmed non-small cell lung carcinoma, 3. No previous treatment for NSCLC, 4. Indication to EGFR status determination following HAS recommendation, 5. Voluntary signed and dated written informed consent prior to any study specific procedure 6. Patients with a social security in compliance with the French Law.
Exclusion criteria
1. Treatment for advanced NSCLC started before liquid biopsy sampling. 2. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis | within 3 weeks after signature of informed consent | Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only | within 3 weeks after signature of informed consent | A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis |
| The detection rate of patients with an EGFR actionable alteration based on tissue analysis only | within 3 weeks after signature of informed consent | A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue |
| The concordance and discordance rates between the two procedures | within 3 weeks after signature of informed consent | Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different. |
| The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure) | within 3 weeks after signature of informed consent | • Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure) |
| Delay to obtain sequencing results | within 3 weeks after signature of informed consent | The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure |
| Delay for treatment initiation | within 3 months after signature of informed consent | The delay between the date of sample collection and the date of treatment initiation |
Countries
France
Outcome results
None listed