Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed primary or secondary advanced non-small cell lung cancer
Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
Karnofsky performance status of ≥ 70
Expected survival of ≥ 3 months
Greater than or equal to 18 years of age
Absolute granulocyte count ≥ 2.5 x 10\*\*9/L
Lymphocyte count \> 0.7 x 10\*\*9/L
Platelet count ≥ 100 x 10\*\*9/L
Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
Total bilirubin \< 2 mg/dl or 34µmol (SI unit equivalent)
Ability to provide written informed consent
You may not be if
Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
Exposure to an investigational agent within four weeks of the BIBH 1 infusion
Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
Women who are breast-feeding or pregnant
Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
Previous participation in this study
Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
Patients who experienced a myocardial infarction within 3 months of Screening.
