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Sponsor: Aetion, Inc.
Conditions: Metastatic Nonsmall Cell Lung Cancer
Interventions: Pembrolizumab, Pemetrexed, Cisplatin, Carboplatin
The goal of this non-interventional study is to emulate the KEYNOTE-189 randomized controlled trial of pembrolizumab for the treatment of metastatic non-small cell lung cancer using real-world, electronic health record data. The main questions this study aims to answer are: 1. Do patients with metastatic non-small cell lung cancer (NSCLC) treated with pemetrexed, cisplatin/carboplatin, and pembrolizumab have improved real-world overall survival (rwOS) and real-world progression-free survival (rwPFS) compared with patients treated with pemetrexed and cisplatin/carboplatin alone? 2. How do the results of this non-interventional study compare to those of the KEYNOTE-189 randomized controlled trial?
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * Non-small cell lung cancer (NSCLC) diagnosis * Histology not indicative of squamous cell carcinoma * Metastatic disease * Epidermal growth factor receptor (EGFR) and Anaplastic lymphoma kinase (ALK)-negative or Kirsten rat sarcoma viral oncogene homolog (KRAS)-positive * No prior systemic treatment for metastatic NSCLC * No record of adjuvant or neoadjuvant therapy in the 12 months before metastatic diagnosis * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or missing or Karnofsky performance status \>=70 or missing * No lab results indicating inadequate organ function, as defined in the KEYNOTE-189 RCT protocol Exclusion Criteria: * Histology indicative of squamous cell carcinoma or small cell elements * Prior systemic treatment for metastatic NSCLC * Prior antineoplastic biological therapy * History of major cancer-related surgery in the 3 weeks before study drug initiation * Radiation therapy to the lung \>30 Gy in the 6 months before study drug initiation * Prior diagnosis of clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction * Diagnosis of a second primary malignant neoplasm * Diagnosis of brain, central nervous system, and/or spinal cord metastases * Diagnosis of autoimmune disease and treatment with corticosteroids or immunosuppressive drugs after diagnosis and within the 2 years prior to study drug initiation * Treatment with a non-topical systemic steroid in each of the 6 months prior to study drug initiation * Prior treatment with pembrolizumab or any other anti-PD-1, PD-L1, PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms * Treatment with non-topical antibiotics, antifungals, or antivirals within 2 weeks after an infection diagnosis in the month prior to study drug initiation * Diagnosis of human immunodeficiency virus infection * Diagnosis of acute hepatitis B or C * Diagnosis of ascites or plural effusion in the 3 months prior to study drug initiation * Prior diagnosis of interstitial lung disease or diagnosis of pneumonitis and record of treatment with glucocorticoids within 30 days