Studieoverzicht

Study name: Krascendo 2

Histology NSCLC, all subtypes
Tumor stage Stage III - IV
Host / recruiting site 1 Antoni van Leeuwenhoek Enrollment Recruiting
Therapy line First line (1L)
PD-L1 expression Negative: <1%Low: 1 - 49%High: ≥50%
Design

Randomized

Intervention

Divarasib 400mg PO QD + Pembrolizumab 200mg IV Q3W
Pembrolizumab 200mg IV Q3W + Pemetrexed 500mg/m2 Q3W + Carboplatin AUC 5 IV Q3W

Key inclusion criteria

• ECOG Performance Status of 0 or 1
• Measurable disease, as defined by RECIST v1.1
• Individuals who have received prior neoadjuvant, adjuvant, or perioperative therapy, or chemoradiotherapy followed by consolidation therapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 12 months from study enrollment since the last dose of systemic therapy and/or radiotherapy.

Key exclusion criteria

• Known concomitant second oncogenic driver with available targeted treatment (including, but not exclusively limited to, EGFR mutations, ALK rearrangement, ROS1 rearrangement, BRAFV600E mutation, NTRK fusions, RET fusions, MET exon 14 skipping mutations).
• Symptomatic, untreated, or actively progressing CNS metastases
• Uncontrolled tumor-related pain
• Radiation to the lung  30 Gy within 6 months prior to randomization;

Contact information