advanced or metastatic non-squamous non-small cell lung cancer
Conditions
Interventions
Screening procedures, and quality of life assessments within 28 days, and
baseline radiographic tumor assessments within 28 days will be performed prior
to randomization.
Subjects randomized to re
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be >= 18 years of age. 2. Life expectancy > 12 weeks (as per Investigator's clinical assessment). 3. Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC. Subjects with mixed histology tumors will be eligible if the tumor is predominant non-squamous histology and does not include tumor with small cell histology. Subjects must have a pathologist's report confirming non-squamous NSCLC available for collection by the sponsor. Subjects with EGFR mutation (exon 19 deletion or L858R mutation in exon 21) and/or ALK gene rearrangement must have progressed after first line monotherapy treatment with targeted therapy. 4. Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening. 5. Subjects must be current smokers (defined as having > 100 smoking events lifetime and having smoked within the past year) or former smokers (defined as having > 100 smoking events lifetime and having not smoked within the past year). 6. Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). 7. Subject must consent to provide archived tissue or cytology sample of NSCLC lesion (primary or metastatic) for analysis if available. 8. Subject must have no history of brain metastases or evidence of CNS tumors at screening assessment. Subjects with signs or symptoms of CNS involvement will undergo MRI (or CT scan if MRI is contraindicated) to confirm absence of CNS metastases. 9. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 1. 10. Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator. 11. Subject must have adequate bone marrow, renal and hepatic function as follows: • Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 × 109/L); • Platelets >= 100,000/mm3 (100 × 109/L); Hemoglobin >= 9.0 g/dL; • Renal function: serum calculated creatinine clearance > 50 mL/min according to the Cockroft-Gault formula; confirmation of creatinine clearance/GFR may be done by a local direct measurement method (e.g., 24 hour urine collection or radioisotope) at the investigator's discretion; • Hepatic function: AST and ALT = 1.5 × ULN. 12. Female subjects of childbearing potential (i.e., those who are not postmenopausal for at least 1 year or surgically sterile by bilateral tubal ligation, bilateral oophorectomy or hysterectomy) and their male partners should practice at least one of the methods of birth control listed below during study and for at least 6 months after treatment with paclitaxel chemotherapy. Male subjects and their female partners of childbearing potential should practice at least one of the methods of birth control listed below during study and for at least 6 months after treatment with chemotherapy: • • total abstinence from sexual intercourse (if it is the subject's preferred and usual lifestyle; for • beginning a minimum one complete menstrual cycle prior to study drug administration and • to extend 6 months after treatment): • • vasectomized subject or partner(s); vasec
Exclusion criteria
Exclusion criteria: 1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor). 2. Subject has a known hypersensitivity to platinum compounds. 3. Subjects with peripheral neuropathy >= grade 2. 4. Subjects with squamous NSCLC, or those with an untreated EGFR mutation (exon 19 deletion or L858R mutation in exon 21) and/or ALK gene rearrangement. Subjects' EGFR mutation and ALK gene rearrangement status must be known prior to study entry. 5. A history of seizure within 12 months prior to study entry. 6. Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC, except adjuvant or neoadjuvant therapy > 12 months prior to C1D-2 or subject has received targeted small molecule monotherapy for EGFR and/or ALK-positive disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is overall survival (OS) in LSP positive subgroup. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints are - overall survival in all subjects and in the LSP positive subgroup - progression-free survival (PFS) in the LSP positive subgroup - objective response rate (ORR) in the LSP positive subgroup | — |
Countries
Netherlands
Outcome results
None listed