non-small cell lung cancer
Conditions
Interventions
Patients will receive standard chemotherapy consisting of carboplatin AUC 5, d1
plus paclitaxel 175 mg/m2, d1, q3 weeks as an IV infusion for a maximum of 3
cycles. Patients in the second cohort wil
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and toxicity of TIL with or without Pembrolizumab after carboplatin based chemotherapy according to CTCAE 5.0 criteria. | — |
Countries
Netherlands
Outcome results
None listed