An interventional study of Drug skin tests (investigating hypersensitivity to a biotherapy) in Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms and Small Cell Bronchial Carcinomas, sponsored by University Hospital, Angers. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other
Among 19 studies in Carcinoma, Bronchogenic with a site in France — 4 open to participants now, 7 under way, 1 of them phase 3. Carcinoma, Bronchogenic · France.
Among the 19 studies in Carcinoma, Bronchogenic with a site in France, this one is the 9th largest by planned enrollment of the 12 interventional ones, is the only one that started in 2026, is one of 5 with no phase, and was the 18th registered.
66 studies on the registry are indexed under Carcinoma, Bronchogenic; 12 are open to participants now.
This study's planned enrollment of 70 is below the median of 102 across 50 interventional studies indexed under Carcinoma, Bronchogenic.
Browse Carcinoma, Bronchogenic studies →4 of the 19 studies in Carcinoma, Bronchogenic with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 12 Carcinoma, Bronchogenic studies recruiting now, 11 (92%) set no upper age limit and 1 (8%) stop at 75 or younger; 2 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2026.
Median enrollment 216 across the 12 interventional studies, 200 across the 7 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
9 of 19 have an industry lead sponsor. The 10 most frequent:
University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
University Hospital, Angers has 2 studies filed under Carcinoma, Bronchogenic — fewer than ten, so there is no comparison to draw.
1 of the studies in Carcinoma, Bronchogenic with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06119581Phase 3Eli Lilly and CompanyA Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer | 2027-11 |
Among the 19 studies in Carcinoma, Bronchogenic with a site in France, from their registry updates:
Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.
These biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).
Unlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Drug skin tests (investigating hypersensitivity to a biotherapy)
allergologic skin tests (prick tests and intradermal tests)
maximum usable concentration considered non-irritant
For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing.
Time frame: Day 1
possible occurrence of a delayed reaction at 48 hours post-testing
delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours after injection, or if a systemic reaction occurs following biotherapy administration.
Time frame: Day 2
possible occurrence of a delayed reaction at one week post-testing
delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 1 week after injection
Time frame: Day 7
Plan to share: Yes — Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Supporting information: Study protocol
Time frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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