• 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,…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The longitudinal 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 outcome
Not applicable.
Background summary
There 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 lungcarcinoma-specific T cell immunity upon
immunotherapeutic treatment. Better knowledge on the 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 been
developed or are currently used in NSCLC potentially exert ther effect in part
through the induction of a lung carinoma-specific T cell response. In this
concept chemotherapy or targeted therapy might 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 relationship between treatment of lung carcinoma with these
types of drugs and the development of tumor-specific T cell responses, either
in peripheral blood or at the tumor site.
Study objective
• 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.
• 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.
• To examine the repertoire of potential T cell antigens in NSCLC lesions by
genomic analysis.
Study design
Longitudinal analysis: 50 patients were asked to provide blood and tumor tissue
to allow further translational research in the laboratory.
Study burden and risks
The downside of participation in this study is that there will be more blood
taken than normal. There will be also at least 2 tumor biopsies taken, what
possibly can give an infection, hemorrhage, bruising or other discomfort, like
fair feeling. The blood tests and tumor biopsies will be combined as far as
possible with the regular visits to the clinic, so that the patient shouldn't
come specially to the hospital.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
• Histologically or cytologically proven irresectable stage III or IV non-small cell lung cancer
• Age above 18 years
• Performance score: WHO 0, 1 or 2 at the time of study entry
• Written informed consent
• Specific inclusion criteria for tissue biopsies:
- Only target lesion with limited biopsy-procedure related complication risk will be sampled; For instance easily accessible peripheral lymph nodes, subcutaneous, pleural, liver metastastasis.
- 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).
- Only non-irradiated lesions will be sampled
Exclusion criteria
• Severe anemia (Hb < 6.0 mmol/L)
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL41664.031.12 |
OMON | NL-OMON25535 |