Clinical trial · Observational
CARE Initiative: Real-world Emulation of the KEYNOTE-189 Trial [DS3]
CARE Initiative Study: Real-world Emulation of the KEYNOTE-189 Comparative Effectiveness Trial of Pembrolizumab, Pemetrexed, and Chemotherapy vs. Placebo, Pemetrexed, and Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Exposed
- description
- Patients initiating pemetrexed, cisplatin or carboplatin, and pembrolizumab as first-line treatment for metastatic NSCLC
- interventionNames
- Drug: Pembrolizumab
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- label
- Comparator
- description
- Patients initiating pemetrexed and cisplatin or carboplatin as first-line treatment for metastatic NSCLC
- interventionNames
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Primary outcomes (2)
- measure
- Real-world overall survival (rwOS)
- timeFrame
- From study treatment initiation until the date of death from any cause or censoring, whichever came first, assessed up to 20.4 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDGandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16. PMID 29658856