Study ID: S1400-K
Phase II study of ABBV-399 (Process II) in patients with cMet-positive stage IV or recurrent squamous cell lung cancer (LUNG-MAP sub-study)
This study seeks to determine the safety and effectiveness of the antibody medication telisotuzumab vedotin (ABBV-399) in patients whose stage IV or recurrent squamous cell lung cancer tests positive for the protein cMet. Researchers are trying to determine if the drug, which is currently being investigated to treat non-small cell lung cancer, can help those with certain types of squamous cell lung cancer.
- Must have an IHC positive based on Ventana SP44 assay (H score ≥ 150).
- Must have progressed during or after prior platinum-based chemotherapy. For Stage I-III disease patients, progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy.
- Must not have peripheral edema > Grade 1 or peripheral neuropathy > Grade 1 at the time of sub-study registration.
- Must not have received prior treatment with cMet pathway inhibitors. And must not be taking strong CYP3A4 inhibitors within seven days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment.
- Must have albumin ≥ 3.0 g/dL within 28 days prior to sub-study registration.
- Must have adequate hepatic function as defined by serum bilirubin ≤ Institutional Upper Limit of Normal (IULN) and either ALT or AST ≤ 2.5 x IULN (if both ALT and AST are done, both must be < 2.5 IULN) and gamma-glutamyl transferase (GGT) ≤5 x ULN within 28 days prior to sub-study registration.
- Must not have extensive metastatic liver disease involving ≥ 50% of the liver in the judgment of the investigator or sum of longest diameters of RECIST measurable liver lesions ≥10 cm.
- Must not be pregnant or nursing, and must agree to use an effective contraceptive method.
- Must have been diagnosed with stage IV or recurrent squamous cell lung cancer.
- Patients must first be registered to S1400, and then be assigned to this sub-study.