Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03265496
Other study ID # CONCORDE-1510
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 7, 2016
Est. completion date April 13, 2021

Study information

Verified date October 2021
Source Centre Oscar Lambret
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.


Description:

Newest therapeutic breakthrough are often based on molecular analysis of tumoral tissue before treatment initiation or after emergence of resistance. Tumoral tissue is commonly obtained by biopsy. However, tumor biopsy is an invasive, scarcely repeatable and costly technics. Moreover, tumor samples, obtained by biopsy, doesn't represent tumor heterogeneity and cannot inform about tumor evolution over time. Recent improvement have been done in detection and characterization of blood circulating tumoral DNA (ctDNA). ctDNA reach regularly the blood stream after tumoral cell apoptosis or necrosis and could be extract and sequenced by some molecular biology technics such as real time PCR (rtPCR), digital PCR (dPCR) or next generation sequencing (NGS). Interesting, Several studies demonstrate that some genomic alterations of solid cancer can be characterized after sequencing of ctDNA. Other experiments pointed that ctDNA level could be linked to tumor stage and patient prognostic. These progress lead to the development of a new non invasive method for extraction of ctDNA called liquid biopsy (LB). LB could be useful for monitor tumoral genotype, assess tumor response to treatment and detect residual tumor cells after curative treatment. Moreover LB could be an essential method for study of tumor cells molecular alterations mechanisms during targeted cancer therapies, when clinical resistance occurs. Non-small cell lung cancer (NSCLC) is the most frequently diagnosticated type of lung cancer. Regular first line chemotherapy is based on the use of platinum salts. However, some mutations in the EGFR gene could add sensitivity of NSCLC to tyrosine kinase inhibitors such as gefitinib, erlotinib or afatinib. Consequently, the search for molecular mutations in genome of NSCLC cells is of prior interest for patients with clinically advanced NSCLC. Recently, some studies demonstrate that mutational EGFR status of NSCLC was sharply correlated between tumoral tissue, obtained by classical biopsy, and ctDNA, collected by liquid biopsy. These results provide promising data encouraging the use of LB for study of NSCLC ctDNA. However some experimentations are needed to ensure these data. For that reason, CONCORDE clinical trial will evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date April 13, 2021
Est. primary completion date April 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years - Metastatic lung carcinoma - With: - EGFR gene mutation - Or at least 2 predictive factors of addictive mutation (Women, non smocking or cessation > 3 years, Asiatic, lung adenocarcinoma) - Eligible for 1st line treatment - Performance status = 3 - Available tumor sample or tumor reachable for biopsy - With informed and signed consent - Affiliation to the National Social Security System Exclusion Criteria: - Previous radiotherapy treatment in months preceding initials samples - Pregnant or breastfeeding women - Patient not able to give consent or unwilling to provide consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Clinical exam
Clinical exam is performed before treatment start
Liquid biopsy
Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease
Diagnostic exam
Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.
Drug:
1st line treatment
1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.
Procedure:
tumor evaluation
Tumor evaluation will be performed every 3 cycles of chemotherapy
Biological:
Biopsy
Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.

Locations

Country Name City State
France Centre Oscar Lambret Lille
France CHRU Lille Lille

Sponsors (2)

Lead Sponsor Collaborator
Centre Oscar Lambret University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Mutation in ctDNA To detect, at early stage, mutations on liquid biopsy. To identify, at early stage, mutations leading to treatment resistance by Next Generation Sequencing. From Baseline to disease progression, up to 2 years
Other expression pattern of tumor grade and resistance To identify a predictive expression pattern for grade and treatment resistance of tumor by iterative sampling during treatment From Baseline to disease progression, up to 2 years
Primary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS. For patient with mutant EGFR. Evaluate, by next generation sequencing at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. Baseline
Secondary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. rtPCR. For patient with mutant EGFR. Evaluate, by real time PCR at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. Baseline
Secondary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. dPCR. For patient with mutant EGFR. Evaluate, by digital PCR at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. Baseline
Secondary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. NGS. For patient with mutant EGFR. Evaluate, by Next Generation Sequencing at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. From Baseline to disease progression, up to 2 years
Secondary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. rtPCR. For patient with mutant EGFR. Evaluate, by rtPCR at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. From Baseline to disease progression, up to 2 years
Secondary Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. dPCR. For patient with mutant EGFR. Evaluate, by dPCR at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. From Baseline to disease progression, up to 2 years
Secondary Incidence of oncogenic mutation for patients with predictive factors To evaluate the incidence of oncogenic mutations in populations with clinical predictive factors of these mutations. From Baseline to disease progression, up to 2 years
Secondary Predictive value of ctDNA during treatment with EGFR targeting therapy. To assess the predictive value of mutant ctDNA during treatment with EGFR targeting therapy. From Baseline to disease progression, up to 2 years
Secondary Mutations on ctDNA and tumor biopsy. To search for mutations leading to treatment resistance on ctDNA and tumor biopsy at proved disease progression From Baseline to disease progression, up to 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05821933 - RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC Phase 1/Phase 2
Active, not recruiting NCT03269162 - Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection Phase 3
Recruiting NCT05002270 - JAB-21822 Activity in Adult Patients With Advanced Solid Tumors Harboring KRAS G12C Mutation Phase 1/Phase 2
Recruiting NCT06315686 - The Dynamic Monitoring of Cerebrospinal Fluid ctDNA Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Recruiting NCT05466149 - Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT03609918 - Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
Recruiting NCT06043817 - First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Phase 1/Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT05078931 - A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients Phase 2
Not yet recruiting NCT05547737 - Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Withdrawn NCT05959473 - EGFR_IUO 3.20 Clinical Study Protocol N/A
Not yet recruiting NCT05005468 - A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC. Phase 2
Recruiting NCT01690390 - Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease Phase 2
Completed NCT01852578 - Cabazitaxel in Relapsed and Metastatic NSCLC Phase 2
Active, not recruiting NCT01460472 - Immunotherapy With Racotumomab in Advanced Lung Cancer Phase 3
Completed NCT00702975 - Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy Phase 2
Completed NCT00866970 - Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia Phase 2