Studieoverzicht
Study name: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (Krascendo 2)
| Histology | NSCLC, only non-squamous | ||
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| Tumor stage | Stage III - IV | ||
| NCT Id | NCT06793215 | ||
| Host / recruiting site 1 | Amphia | Enrollment | Recruiting |
| Therapy line | First line (1L) | ||
| PD-L1 expression | Negative: <1%Low: 1 - 49%High: ≥50% | ||
| Design |
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC). |
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| Intervention | DRUG: Divarasib Divarasib will be administered orally QD DRUG: Pembrolizumab Pembrolizumab will be administered via IV infusion Q3W DRUG: Pemetrexed Pemetrexed will be administered via IV infusion Q3W DRUG: Carboplatin Carboplatin will be administered via IV infusion Q3W DRUG: Cisplatin Cisplatin will be administered via IV infusion Q3W |
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| Key outcome parameters |
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| Key inclusion criteria |
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| Key exclusion criteria | Exclusion Criteria Related to NSCLC:
Exclusion Criteria Related to Current or Prior Treatments:
Exclusion Criteria Related to General Health:
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| Contact information | Log in voor de contactinformatie | ||

