CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3]
Completed
- Conditions
- Interventions
- Registration Number
- NCT06607393
- Lead Sponsor
- Aetion, Inc.
- Brief Summary
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:
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- Detailed Description
The Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation (CARE) Initiative is a program designed to build an empirical evidence base for the use of real-world data (RWD) in clinical and regulatory decision-making. Using randomized controlled trials (RCTs) as a benchmark for causal effect estimates, a series of RCT emulations...
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 851
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Comparator Carboplatin Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC Exposed Cisplatin Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC Exposed Carboplatin Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC Comparator Pemetrexed Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC Comparator Cisplatin Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC Exposed Pembrolizumab Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC Exposed Pemetrexed Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
- Primary Outcome Measures
Name Time Method Real-world overall survival (rwOS) From study treatment initiation until the date of death from any cause or censoring, whichever came first, assessed up to 20.4 months. Time from study treatment initiation to death
Real-world progression-free survival (rwPFS) From study treatment initiation until the date of disease progression, death from any cause or censoring, whichever came first, assessed up to 20.4 months. Time from study treatment initiation to disease progression or death
- Secondary Outcome Measures
Name Time Method