An interventional study of RNAseq in Non-small Cell Lung Cancer and ALK Gene Rearrangement Positive, sponsored by Groupe Francais De Pneumo-Cancerologie. Recruiting at 46 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Groupe Francais De Pneumo-Cancerologie · Not applicable, Interventional, and Basic science
Among 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France — 170 open to participants now, 328 under way, 106 of them phase 3. Carcinoma, Non-Small-Cell Lung · France.
Among the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, this one is the 528th largest by planned enrollment of the 759 interventional ones, is one of 68 that started in 2021, is one of 58 with no phase, reaches primary completion later than 150 of the 325 other live ones, and was the 601st registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →170 of the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →872 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 68 started in 2021.
Median enrollment 190 across the 759 interventional studies, 151 across the 104 observational. Of the 512 that completed or were terminated, 257 (50%) have results posted.
611 of 872 have an industry lead sponsor. The 10 most frequent:
Groupe Francais De Pneumo-Cancerologie is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Groupe Francais De Pneumo-Cancerologie has 8 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
68 of the studies in Carcinoma, Non-Small-Cell Lung with a site in France that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT06430866Phase 3AmgenPharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) | 2026-12-14 |
| NCT03774732Phase 3UNICANCERPD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer | 2026-12-22 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
Among the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, from their registry updates:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients.
BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study.
Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA).
For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon).
Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with new generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019).
Explore ALK GFPC 03-2019 is a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients, whose RCB reference is 2020-A00771-38 and which obtained an approval from the IDF II Ethic Committee on 25/05/2020. Biological analysis will be performed on tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA) on three timepoints (diagnosis, at first tumor evaluation and at the time of disease progression).
For plasma testing, after obtained patient consent, blood samples (35mL on EDTA or STRECKs tubes) at diagnosis, at the first evaluation and at disease progression will be taken.
The ALKis include alectinib and brigatinib as first-line therapy or other drugs with marketing authorizations (lorlatinib, entrectinib) or in early access programs (EAPs).
Liquid biopsies will be analyzed with a NGS panel allowing the identification of ALK fusion partners and resistance mechanisms (mutations, fusions, copy number variations). Samples will be sent for centralized analysis to the Léon Bérard Center (Lyon).
For biological analysis on tissue obtained at diagnosis, the ALK fusion partner and its variant will be identified by RNAseq. Whenever a tissue re-biopsy is performed at the time of disease progression as part of the standard of care management of the patient, the remaining tissue sample will be collected as part of the BioExALK study, so that RNAseq analysis will be performed to look for resistance mechanisms. Tissue samples (10 slides of 5 microns) will be sent for centralized analysis to the Rouen University Hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients included in Explore ALK GFPC 03-2019 study who agree to participate in Bioexalk.
Genetic: RNAseq
1. Tissue : RNAseq will be performed on tumor biopsy (10 slides of 5 microns) to identify the ALK fusion partner and its variant and associated co-mutations. 2. ctDNA : NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples
Also known as: DNA NGS
Progression Free Survival (PFS)
PFS assessed by local review using RECIST v1.1, defined as time from treatment initiation to the first clinical or radiological progression or death from any cause
Time frame: From date of treatment initiation up to 72 months
Overall Survival (OS)
OS defined as time from treatment initiation to death from any cause.
Time frame: From date of treatment initiation up to 72 months
Duration of Response (DoR)
DoR assessed by local review using RECIST v1.1, defined as time from treatment initiation to the first clinical or radiological progression, death, consent withdrawn, adverse event, protocol deviations, lost to follow-up, or initiation of a new line of anticancer therapy.
Time frame: From date of treatment initiation up to 72 months
Overall Response Rate (ORR)
ORR defined as objective response rate of complete response or partial response measured by local review RECIST v1.1.
Time frame: From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Progression Free Survival (PFS) of stage IV ALK-rearranged NSCLC patients
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Time frame: From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Overall Survival (OS) of stage IV ALK-rearranged NSCLC patients
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Time frame: From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Duration of Response (DoR) of stage IV ALK-rearranged NSCLC patients
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Time frame: From date of treatment initiation up to 72 months
Circulating tumoral DNA (ctDNA) clearance on Overall Response Rate (ORR) of stage IV ALK-rearranged NSCLC patients
ctDNA clearance will be determine as clearance of the fusion when detectable and/or clearance of relevant mutations when fusion not detected
Time frame: From date of treatment initiation up to 72 months
Description of mechanisms of resistance associated with first-line tyrosine kinase inhibitors
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
Time frame: From date of treatment initiation up to 72 months
Description of mechanism of resistance associated with each ALK-fusion partner
The following mechanisms of resistance will be assessed: secondary mutations on ALK, mutations or translocations on other genes of interest, histological transformations
Time frame: From date of treatment initiation up to 72 months
Concordance between ALK fusion partner and co-mutations
ALK fusion partner and co-mutation identifications based on liquid and tissue biopsies at Baseline
Time frame: From date of treatment initiation up to 72 months
Impact of presence or absence of serum Anti-ALK antibodies at diagnosis on OS
Time frame: From date of treatment initiation up to 72 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Jun 2027, 69 months after the start.
Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 69 months is above that.
Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
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Carcinoma, Non-Small-Cell Lung →
Groupe Francais De Pneumo-Cancerologie