This is a phase II study to assess the efficacy, safety, and Health Related Quality of Life (HRQoL) of combination cabozantinib and pembrolizumab as maintenance therapy for patients with metastatic squamous Non Small Cell Lung Cancer(sqNSCLC) who have received 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel.
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0, 1, or 2 within 28 days prior to registration
Life expectancy of 6 months or greater as determined by the site investigator.
Active infection requiring systemic therapy.
Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
Prior treatment with cabozantinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
Single group
Pacliltaxel or Nab-paclitaxel
DrugIndividuals will receive either paclitaxel or nab-paclitaxel as part of their induction treatment. Paclitaxel will be administered as a 200 mg/m2 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days). Nab-paclitaxel will be administered as a 100 mg/m2 IV infusion on Days 1, 8, and 15 of Cycles 1-4 (1 cycles = 21 days)
Carboplatin or Cisplatin
DrugIndividuals will receive either paclitaxel or nab-paclitaxel as part of their induction treatment. Carboplatin will be administered as an AUC6 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days). Cisplatin will be administered as a 75 mg/m2 IV infusion on Day 1 of Cycles 1-4 (1 cycle = 21 days).
Pembrolizumab
DrugFor the induction phase, pembrolizumab will be given as a 200 mg IV infusion on Day 1 of Cycles 1-4 of Induction (1 cycle = 21 days). For the maintenance phase, pembrolizumab will be given as a 200 mg IV infusion on Day 1 of each cycle (1 cycle = 21 days).
Cabozantinib
DrugFor the maintenance phase, cabozantinib will be given at 40 mg orally each day for Days 1-21 of each cycle of maintenance (1 cycle = 21 days)
To estimate the median progression-free survival (PFS) of individuals with metastatic squamous non-small cell lung cancer (sqNSCLC)
To estimate the median progression-free survival (PFS) of metastatic squamous non-small cell lung cancer (sqNSCLC) treated with maintenance cabozantinib in combination with pembrolizumab with disease control (defined as complete response, partial response, or stable disease) following standard first-line induction therapy with chemotherapy with pembrolizumab.
Adverse events as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Characterize adverse effects (AEs) of cabozantinib in combination with pembrolizumab in subjects with disease control (defined as complete response, CR; partial response, PR; or stable disease, SD) following standard induction first-line therapy.
Estimate 6 month progression free survival (PFS) using RECIST v1.1 in subjects with disease control following standard first-line induction therapy who received cabozantinib in combination with pembrolizumab as maintenance therapy
PFS time using RECIST v1.1
Estimate 12 month progression free survival (PFS) using RECIST v1.1 in subjects with disease control following standard first-line induction therapy who received cabozantinib in combination with pembrolizumab as maintenance therapy
PFS time using RECIST v1.1
Estimate median 12 months overall survival (OS) using RECIST v1.1 in subjects with disease control following standard first-line induction therapy who received cabozantinib in combination with pembrolizumab as maintenance therapy
Number of subjects achieving OS using RECIST v1.1
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