advanced or metastatic lung cancer squamous non-small cell lung cancer
Conditions
Interventions
Screening procedures, quality of life assessment within 21 days, and baseline
radiographic tumor assessments within 28 days will be performed prior to
starting treatment on C1D-2 (i.e., the first da
Sponsors
AbbVie
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 squamous NSCLC. Subjects with mixed histology tumors will be eligible if the tumor is predominantly squamous histology and does not include tumor cells with small cell histology. If cytology is used for diagnosis, the sample must be unequivocally and predominantly squamous NSCLC. Subjects must have a pathologist's report confirming squamous NSCLC available for collection by the sponsor. 4. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible. 5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). 6. Subject must consent to provide archived sample of squamous NSCLC lesion (primary or metastatic) biomarker analysis. 7. 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 imaging to confirm absence of CNS metastases. 8. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. 9. Subject must be able to take oral medication (PO). 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 (5.6 mmol/L); • Renal function: serum calculated creatinine clearance > 50 mL/min according to the Cockcroft and Gault equation or urine creatinine clearance >50 mL/min; • Hepatic function: AST and ALT = 1.5 × ULN. Female and male patients of fertile age, and/or theirs partners should use contraception for at least 6 months after treatment with paclitaxel. If male, subject and subject's female partner(s) of childbearing potential should practice at least one of the following methods of birth control. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or the subject and the subject's male partner(s) practicing at least one of the following methods of birth control: * total abstinence from sexual intercourse (if it is the subject's preferred and usual lifestyle; for minimum one complete menstrual cycle prior to study drug administration and to extend 6 months after treatment); * vasectomized subject or partner(s); * hormonal contraceptives (oral, parenteral or transdermal) for at least 90 days prior to study drug administration) for the subject or subject's female partner(s); * intrauterine device (IUD) for the subject or subject's female partner(s); or * double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellie
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. Subject has peripheral neuropathy >= grade 2. 4. Subject has non-squamous NSCLC, or a known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement. According to NCCN guidelines, EGFR and ALK testing should be performed in subjects with squamous NSCLC who have never smoked or in case of small biopsy specimens (as judged by the investigator) or mixed histology. Such subjects should be tested to confirm absence of EGFR mutation or ALK gene rearrangement according to local standard of care prior to study entry. 5. A history of seizure within 12 months prior to study entry. 6. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy. 7. Subject has received adjuvant or neoadjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in the group of current smokers; Time to death starting on randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) in the group of current smokers and PFS in the whole population: number of days randomization till Progressive Disease or death. Objective Response Rate (ORR) in the group of current smokers and ORR in the whole population: proportion of subjects with complete or partial response. | — |
Countries
Netherlands
Outcome results
None listed