Patiënten van de afdeling Thoracale oncologie kunnen deelnemen aan klinische studies fase 2 en 3. Die studies testen het effect van nieuwe medicatie of nieuwe procedures uit voor ze op de markt worden gebracht. Klinische studies worden gecoördineerd en gesuperviseerd door artsen en getrainde studiecoördinatoren. Zij staan borg voor kwalitatief hoogstaande en geactualiseerde patiëntenzorg.
Heb je vragen over de studies op onze afdeling? Neem gerust contact op.
- Voor patiënten en verwijzers: thoraxoncologie@uzgent.be
- Voor sponsors en CRO: pneumostudies@uzgent.be
Lopende studies
Hieronder vind je een overzicht van de klinische studies op de afdeling Thoracale oncologie die nu of binnenkort open zijn voor rekrutering (update mei 2024). Alle studies zijn goedgekeurd door de Commissie voor medische ethiek van het UZ Gent.
- Niet-kleincellig longcarcinoom
- Kleincellig longcarcinoom
- Mesothelioom
- Translationeel onderzoek
- Revalidatie
- Fase 1
Niet-kleincellig longcarcinoom
Niet-metastatisch
Interpath-009 (MSD)
A phase 3 randomized double-blind study of adjuvant pembrolizumab with or without V940 in participants with resectable stage II to IIIB (N2) NSCLC not achieving pCR after receiving neoadjuvant pembrolizumab with platinum-based doublet chemotherapy (INTerpath-009).
- First line
- WHO/ECOG PS 0-1
Contact: tasja.verstraete@uzgent.be, tel 09 332 59 12
Rosetta Lung-201 (BMS)
A randomized, multicenter, open-label phase 3 study of pumitamig monotherapy compared to durvalumab in participants with unresectable stage III NSCLC without progression after platinum-based concurrent chemoradiation therapy.
- NSCLC stadium III
- First line after platinum-based concurrent chemoradiation therapy
- WHO 0-1
Contact: jolien.buyle@uzgent.be, tel 09 332 27 55
Metastatisch, geen oncogene driver mutatie
Summit (Summit Therapeutics)
A randomized, double-blinded, multiregional phase 3 study of Ivonescimab versus Pembrolizumab for the first-line treatment of metastatic non-small cell lung cancer in patients whose tumors demonstrate high PD-L1 Expression (TPS ≥ 50%)
- First line
- Stage IV
- WHO 0-1
- PD-L1 ≥ 50%
Contact: frauke.vandewalle@uzgent.be, tel. 09 332 46 23
Dare-Lung (UZ Gent) binnenkort beschikbaar
A phase 1b/2a study of an autologous dendritic cell immunotherapy in combination with anti-programmed death-1 treatment in patients with metastatic non small-cell lung cancer
- Cohort 3: PD na IO +/- CT
- WHO 0-1
- Stage IV
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
Herthena PANtumor01 (Daiichi-Sankyo)
A phase 2, multicenter, multicohort, open-label, proof of concept study of Patritumab Deruxtecan (HER3-DXd: U3-1402) in subjects with locally advanced or metastatic solid tumors
- 2nd line
- WHO 0-1
- NSCLC
- Tissue available
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
Abbvie M18-868 (Abbvie)
A phase 3 open-label, randomized, controlled, global study of Telisotuzumab Vedotin (ABBV-399) versus docetaxel in subjects with previously treated c-Met Overexpressing, EGFR Wildtype, locally advanced/metastatic non-squamous non-small cell lung
- 2nd line
- WHO 0-1
- c-Met overexpression
- Tisue available
Contact: nathalie.deboosere@uzgent.be, tel. 09 332 05 26 of frauke.vandewalle@uzgent.be, tel. 09 332 46 23
Rosetta Lung-02 (BioNTech)
A phase 3, multisite, randomized master protocol for a global trial of BNT327 (pumitamig) in combination with chemotherapy and other investigational agents in first-line non-small lung cancer
- NSCLC stadium IIIB/C of stadium IV
- Non-squamous or squamous
- PD-L1 0-100%
- First line
- WHO 0-1
Contact: nathalie.deboosere@uzgent.be, tel 09 332 05 26
Metastatisch, oncogene driver mutatie
EGFR
LAT-FLOSI (Academisch)
Local Ablative Therapy for oligoprogressive non-small cell lung cancer treated with first-line osimertinib (NCT04216121)
- Radiological confirmed response to osimertinib 3 months after start treatment
- ≤ 3 intra-and extracranial sites of progression
- Available tissue
Contact: jolien.buyle@uzgent.be, tel. 09 332 27 55
Copernicus (J&J)
A phase 2b, open-label, two-cohort study of SC amivantamab in combination with Lazertinib as first-line treatment in participants with EGFR-mutated locally advanced or metastatic NSCLC.
- First line
- WHO 0-1
- Stage IV
Contact: jolien.buyle@uzgent.be, tel. 09 332 27 55
Izabright-lung01 (BMS): binnenkort beschikbaar
A randomized, open-label, phase 2/3 study of Izalontamab Brengitecan (BMS-986507) versus platinum-based chemotherapy in patients with EGFR-mutated NSCLC and disease progression on EGFR TKI therapy (CA244-0010)
- 2nd - 3rd line
- WHO 0-1
- Stadium III-IV
Contact: jolien.buyle@uzgent.be, tel. 09 332 27 55
OSI-SAVE (Erasmus MC)
Increasing the dosing interval of Osimertinib in patients with EGFR mutated locally advanced or metastatic non-small cell lung cancer
- First line
- Stadium IV
- At least 3 months of therapy with osimertinib
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
KRAS G12C
SUNRAY-01 (Lilly): enkel Part A is open
A global pivotal study in participants with KRAS G12C-mutant, locally advanced or metastatic non-small cell lung cancer comparing first-line treatment of LY3537982 and pembrolizumab vs placebo and pembrolizumab in those with PD-L1 expression ≥ 50% or LY3537982 and prembrolizumab, pemetrexed, platinum vs placebo end pembrolizumab, pemetrexed, platinum regardless of PD-L1 expression (NCT06119581)
- First line
- Part A: PD-L1 ≥ 50%
- Part B: PD-L1 0-100%
- WHO/ECOG PS 0-1
Contact: frauke.vandewalle@uzgent.be, tel 09 332 46 23
Codebreak 202 (Amgen) - binnenkort beschikbaar
A global pivotal study in participants with KRAS G12C mutant, locally advanced or metastatic A phase 3, multicenter, randomized, open-label study evaluating efficacy of sotorasib platinum doublet combination versus pembrolizumab platinum doublet combination as a front-line therapy in subjects with stage IV or advanced stage IIIB/C non-squasmous NSCLC, negative for PD-L1 and positive for KRAS p.G12C
- NSCLC non-squamous, PD-L1<1%
- First line
- Stadium IIIB/C or stadium IV
- WHO 0-1
Contact: frauke.vandewalle@uzgent.be, tel 09 332 46 23
Kleincellig longcarcinoom
DeLLphi-308 (Amgen) – geen sloten beschikbaar
A phase 1b study evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of subcutaneous tarlatamab in subjects with extensive stage small cell lung cancer (DeLLphi-308)
- ED SCLC
- WHO/ECOG PS 0-1
- 2L-3L
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
M23-384 (AbbVie) - binnenkort beschikbaar
A phase 3 randomized, open label, multicenter study to evaluate the safety and efficacy of ABBV-706 versus standard of care in subjects with relapsed/refractory small cell lung cancer (SCLC)
- SCLC
- 2L +
- Only Tarlatamab exposed patients
- WHO 0-1
Contact: tasja.verstraete@uzgent.be, tel. 09 332 46 23
DeLLphi-313 (Amgen) – beperkt aantal sloten
A phase 1b study evaluating the safety, tolerability, pharmacokinetics, and efficacy of Tarlatamab in combination with ZL-1310 with or without Anti-PD-L1 in participants with small cell lung cancer.
- SCLC
- Part 1: dose exploration 2L + SCLC
- Tarlatamab naïve patients
- Topoisomerase I inhibitoren naïve patients
- Part 2: dose expansion
- Cohort 2-1: tarlatamab naïve patients, 2L + SCLC
- Cohort 2-2: tarlatamab exposed patients 2L + SCLC
- Part 3: triplet combination, 1L ED-SCLC
- WHO 0-1
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
PRIMALung-study (EORTC) - binnenkort beschikbaar
PRophylactic cerebral irradiation of active magnetic resonance imaging surveillance in small-cell lung cancer patients
- LS- en ES-SCLC
- After standard therapy
- Absence of brain metastases of leptomeningeal disease
- WHO 0-2
Contact: tasja.verstraete@uzgent.be, tel. 09 332 59 12
Mesothelioom
NECIM (Academisch)
Neoadjuvant Chemotherapy plus Immunotherapy in the treatment of borderline unresectable malignant pleural Mesothelioma (NECIM): a feasibility study
- First line
- WHO/ECOG PS 0-1
Contact: frauke.vandewalle@uzgent.be, tel 09 332 46 23
Screening onderzoek
Alcove (UZ Lille): binnenkort beschikbaar
Analysis of Volatile organic comounds in exhaled breath for the early detection of lung cancer.
Contact: nathalie.deboosere@uzgent.be, tel. 09 332 05 26 of frauke.vandewalle@uzgent.be, tel 09 332 46 23
Translationeel onderzoek
LONG 19-04
Prospectieve biobank thoracale oncologie
LONG 16-02
Ontwikkeling van een bloedtest voor de diagnose van thoracale letsels
LONG 21-01
In vitro generatie van autologe dendritische cellen uit leukaferesemateriaal voor immunotherapie: GMP workflow-optimalisatie quality control
Revalidatie
Beweegcoaching na operatie bij patiënten met operabele niet-kleincellige longkanker: een gerandomiseerde studie
Vermoeidheid en bewegen tijdens de behandeling van longkanker
- Lokaal gevorderde, niet-operabele of gemetastaseerde longkanker
- 18 jaar of ouder
- Start met een eerstelijnsbehandeling chemotherapie en/of immunotherapie
Contact: francesca.vanhulle@ugent.be, tel 09 332 51 53
Fase 1
Onze afdeling werkt nauw samen met de dienst Geneesmiddelenonderzoek van het UZ Gent. Een overzicht van de lopende oncologische studies vind je op hun webpagina.
Voor meer info kan je contact opnemen met het secretariaat van de dienst – tel. 09 332 00 00 of geneesmiddelenonderzoek@uzgent.be – of mailen naar artsenfase1@uzgent.be.