search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Longitudinal analysis of lung cancer-specific immunity in stage III and IV non-small cell lung cancer patients.


- candidate number14333
- NTR NumberNTR3844
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-feb-2013
- Secondary IDsNL41664.031.12 CCMO
- Public TitleLongitudinal analysis of lung cancer-specific immunity in stage III and IV non-small cell lung cancer patients.
- Scientific TitleLongitudinal analysis of lung cancer-specific immunity in stage III and IV non-small cell lung cancer patients.
- ACRONYMTranslational research
- hypothesis1. To study the effect of treatment modalities immunotherapy (anti-PD1 or anti-PDL-1), and targeted therapy (crizotinib, gefitinib, or erlotinib) on the size and diversity of lung carcinoma-specific T cell populations as measured by immune assays, including MHC tetramer technology and antigen-specific cytokine production;
2. To examine effect of the treatment modalities immunotherapy (e.g. anti-PD1, anti-PDL-1), and targeted therapy (e.g. crizotinib, gefitinib) on the immune infiltrates present within biopsies;
3. To examine the repertoire of potential T cell antigens in NSCLC lesions by genomic analysis.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. Histologically or cytologically proven irresectable stage III or IV non-small cell lung cancer;
2. Age above 18 years;
3. Performance score: WHO 0, 1 or 2 at the time of study entry;
4. Written informed consent;
5. Specific inclusion criteria for tissue biopsies:
A. Only target lesion with limited biopsy-procedure related complication risk will be sampled; For instance easily accessible peripheral lymph nodes, subcutaneous, pleural, liver metastastasis;
B. Other lesions will only be included if there is a clinical necessity for tissue analysis (e.g. molecular profiling, resection metastasis in case of oligometastastic disease);
C. Only non-irradiated lesions will be sampled.
- Exclusion criteria1. Severe anemia (Hb < 6.0 mmol/L);
2. Any bleeding disorder or anti-coagulation therapy, that cannot be discontinued or corrected, that significantly increases the risk of a bleeding due to the biopsy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 18-jan-2013
- planned closingdate18-jan-2016
- Target number of participants50
- InterventionsTumorbiopsies and peripheral blood samples.
- Primary outcomeThe longiutudinal effects of treatment for irresectable stage III or IV non-small cell lung cancer on tumor material obtained by surgical removal/biopsies and on peripheral blood components.
- Secondary outcomeN/A
- TimepointsBlood sampling will be done prior start of treatment (50ml), at the moment of first response evaluation (100ml), followed by 3 monthly sampling (50ml) , ≤ 3 drawings in total.
From patients who receive this type of treatments, a biopsy (optional) will be taken prior start of treatment, 1-2 weeks after start of treatment and at the time of proven disease progression, in order to study the presence of new genetic mutations that lead to resistance to these targeted agents.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.M. Heuvel, van den
- CONTACT for SCIENTIFIC QUERIESDr. M.M. Heuvel, van den
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- PublicationsN/A
- Brief summaryThere is evidence that tumor-specific T cell responses can contribute to the control of lung carcinoma. However, there is little known about the longitudinal development of non-small cell lung carcinoma-specific T cell responses both in peripheral blood and at the tumor site is likely to offer leads for early monitoring of treatment response and for the development of more targeted immunotherapies. Furthermore, it has been postulated that also other therapeutic strategies that have veen developed or are currently used in NSCLC potentially exert their effect in part through the induction of a lung carcinoma-specific T cell response. In this concept chemotherapy or targeted therapy micht act to 'prime'the immune response, whereas immune checkpoint blockade such as anti-CTLA-4 or anti PD1 acts to 'boost' it by augmenting the immune response. At present, no data are available on the relationschip between treatment of lung carcinoma with these types of drugs and teh development of tumor-specific T cell responses, either in peripheral blood or at the tumor site.
- Main changes (audit trail)
- RECORD11-feb-2013 - 16-feb-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl