Adoptive TIL therapy in combination with chemoimmunotherapy in advanced NSCLC patients
- Conditions
- non-small cell lung cancer10029107
- Registration Number
- NL-OMON53375
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
• Age >=18 years
• Presence of measurable stable or progressive disease according to RECIST
version 1.1.
• Patients must have histologically confirmed metastatic NSCLC with at least
one lesion -primary or metastatic- of sufficient size (> 1 cm in total)
amendable for biopsy and/or resection and must be willing to undergo such a
procedure for experimental purposes. Furthermore there must be at least one
other lesion to monitor response.
• Patients must have radiological stable disease on standard of care first line
treatment with at least two courses of single agent immunotherapy or
chemoimmunotherapy or progressive disease on or after standard of care first
line treatment.
• In case the lung cancer is characterized by an oncogenic driver, patients
must have exhausted all targeted therapies and platinum based chemotherapy.
• Patients must have a clinical performance status of ECOG 0 or 1 and an
expected life expectancy of at least 3 months.
• Requirement for immunosuppressive doses of systemic corticosteroids (>10
mg/day prednisone or equivalent) or other immunosuppressive drugs within the
last 3 weeks prior to start of treatment.
• Patients who have uncontrolled central nervous system (CNS) metastases.
Patients who have asymptomatic CNS metastases no greater than 1 cm before
resection of a tumor lesion for retrieval of TIL may be eligible.
• All toxicities due to prior non-systemic treatment must have recovered to a
grade 1 or less. Patients may have undergone minor surgical procedures or focal
palliative radiotherapy (to non-target lesions) within the past 4 weeks, as
long as all toxicities have recovered to grade 1 or less.
• Serious acute or chronic illnesses, e.g. active infections requiring
antibiotics, bleeding disorders, or other conditions requiring concurrent
medications not allowed during this study.
• Active immunodeficiency disease or autoimmune disease requiring immune
suppressive drugs. Vitiligo is not an exclusion criterion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and toxicity of TIL with or without Pembrolizumab after carboplatin<br /><br>based chemotherapy according to CTCAE 5.0 criteria.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>