Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Palobiofarma SL
With
Ohio State University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies.
No limits to the prior lines of treatment
ECOG performance status of 0/1
Measurable Disease by RECIST v1.1
Age greater than 18 years.
Adequate bone marrow, renal and hepatic function:
* Absolute neutrophil count (ANC) ≥ 1500 /µL
White blood cell count (WBC) t ≥ 2.5 x 109/L (2500/µL)
* Lymphocyte count ≥ 0.5 x 109/L (500/µL)
Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion
Hemoglobin ≥ (9.0 g/dL) - patients may be transfused to meet this criterion.
Aspartate aminotransferase AST, alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
* Creatinine clearance \>60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection
Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
Subject is willing and able to comply with the protocol for the duration of the study
You may not be if
Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
* The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
Concurrent use of other anticancer approved or investigational agents is not allowed.
Autoimmune disorder
Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent
Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used.
Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
