| Eligibility |
Inclusion Criteria:
- Those who will be eligible will be all patients with unresectable and/or metastatic
squamous cell non-small cell lung cancer who have disease which has been previously
treated with an Food & Drug Administration (FDA)- or National Comprehensive Cancer
Network (NCCN)-approved platinum doublet. Patients who have not received such therapy
must have medical reasons for not receiving such therapy. Those who have a molecularly
targetable genetic mutation in their tumor must have also received the appropriate
specific therapy for that mutation. All will be appropriate candidates for
chemotherapy treatment.
Subjects must meet all of the additional following criteria to be eligible for study
participation:
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- Life expectancy > 12 weeks
- Male or female' age >18 years
- Patients of childbearing potential must be using an effective means of contraception.
- Histologic diagnosis of squamous non-small cell lung cancer that has been treated
adequately in the metastatic or unresectable setting with a platinum doublet
chemotherapy regimen and now has evidence of disease progression. Patients may have
also received additional chemotherapy, such as an immune checkpoint inhibitor or no
more than one additional cytotoxic agent (thus participants may have received between
one to three prior lines of therapy for metastatic or unresectable disease).
- Patients who have received platinum-based doublet therapy in the neoadjuvant or
adjuvant setting will only be eligible if they have experienced disease progression
after their last dose of cytotoxic chemotherapy.
- Patients who have a neoplasm for which there currently exists an FDA-approved targeted
therapy (such as to epidermal growth factor receptor [EGFR] activating mutations, or
ALK or ROS1 gene rearrangements) must have received all such targeted therapies and
either exhibited progressive disease through such treatments, or have been shown to be
intolerant of such therapies, prior to enrollment on this study.
- Baseline laboratory values (bone marrow, renal, hepatic):
- Adequate bone marrow function:
- Absolute neutrophil count >1000/µL
- Platelet count >100'000/µL
- Renal function:
- Serum creatinine < 2.0 mg/dL
- Hepatic function:
- Bilirubin <1.5x upper limit of normal (ULN)
- Serum calcium < 12 mg/dL
- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for at least 6 months after
the last dose of study drug to minimize the risk of pregnancy. Prior to study
enrollment, women of childbearing potential must be advised of the importance of
avoiding pregnancy during trial participation and the potential risk factors for an
unintentional pregnancy. WOCBP include any woman who has experienced menarche and who
has not undergone successful surgical sterilization (hysterectomy, bilateral tubal
ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is
defined as:
- Amenorrhea that has lasted for = 12 consecutive months without another cause, or
- For women with irregular menstrual periods who are taking hormone replacement therapy
(HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35
mIU/mL.
- Males with female partners of child-bearing potential must agree to use
physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy)
throughout the study and should avoid conceiving children for 3 months following the
last dose of study drug.
- Subjects must have provided written informed consent and be willing to comply with all
study-related procedures.
Exclusion Criteria:
- Pregnant or lactating females
- Patients with a mixed histology NSCLC, such as adenosquamous carcinoma, where the
squamous component is <50% of the assessed lesion
- Patients with a mixed histology where there are any small cell elements
- Patients who have not received and progressed through, refused, or been intolerant of,
a commonly utilized platinum-doublet therapy (cisplatin or carboplatin paired with
docetaxel, paclitaxel, nab-paclitaxel, gemcitabine, vinorelbine, etoposide or
irinotecan) administered for the treatment of unresectable or metastatic lung cancer.
- Patients who have not received the appropriate prior targeted therapy for their lung
cancer if eligible
- Any invasive malignancy treated within 3 years prior to Cycle 1, Day 1
- Myocardial infarction or ischemia within the 6 months before Cycle 1' Day 1
- Uncontrolled' clinically significant dysrhythmia, or prolonged QT segment
- Uncontrolled malignant disease in the central nervous system (previously treated
disease is eligible, provided it has been radiographically stable for at least four
weeks)
- Radiotherapy within the 2 weeks before Cycle 1, Day 1. If any radiation has been
administered to the target lesion there must be evidence of growth by radiographic
assessments or physical examination
- Major surgery within the 2 weeks before Cycle 1, Day 1
- Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications
- Subjects unwilling to use an acceptable method to avoid pregnancy for the entire study
period and for at least 24 weeks after the last dose of study drug.
- History of any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of protocol therapy or that might affect the interpretation of
the results of the study or that puts the subject at high risk for treatment
complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up
procedures.
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