Status:
COMPLETED
CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3]
Lead Sponsor:
Aetion, Inc.
Collaborating Sponsors:
AbbVie
Amgen
Conditions:
Metastatic Nonsmall Cell Lung Cancer
Eligibility:
All Genders
18+ years
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, electr...
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 (R...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
851 Patients enrolled
Trial Details
Trial ID
NCT06607393
Start Date
February 1 2010
End Date
June 28 2023
Last Update
September 23 2024
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