WHO ICTRP trial
Safety, immunogenicity and preliminary clinical activity study of PDC*lung01…
EUCTR2018-002382-19-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-002382-19-FR |
|---|---|
| Public title | Safety, immunogenicity and preliminary clinical activity study of PDC*lung01 cancer vaccine in NSCLC |
| Scientific title | An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC) |
| Primary sponsor | PDC*line Pharma SAS |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Belgium |
| Conditions | Non-small-cell lung cancer MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area… |
| Interventions | Product Name: PDC*lung01 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Unknown CAS Number: Unknown Current Sponsor code: PDC*lung01 Concentration unit: million organisms/ml million organisms/millilitre Concentration… |
| Registration date | Jan 30, 2019 |
| Target size | 66 |
| Secondary IDs | PDC-LUNG-101 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: