AMGEN 20190009: A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Vs Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Indication :
Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
Spécificités :
Have documentation of KRAS p.G12C mutation confirmed by central testing through the current protocol or Amgen Study 20190294 prior to enrollment.
Contact(s) :
Alfredo Addeo
Principal Investigator
HUG
Oncology
Rue Gabrielle Perret-Gentil, 4
1211
Geneva
+41795535035
Alfredo.Addeo@hcuge.ch
Ludiwine Aeby
Study Coordinator
HUG
Oncology
Rue Gabrielle Perret-Gentil, 4
1211
Geneva
+41795531182
ludiwine.aeby@hcuge.ch
Solange Peters
Principal Investigator
CHUV
Oncology
Rue du Bugnon 46
Lausanne
1011
+41 21 314 44 62
solange.peters@chuv.ch
Primary objective :
To compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated subjects with KRAS p.G12C mutated NSCLC
Inclusion criteria :
- Men or women greater than or equal to 18 years old.
- ECOG ≤ 1
- Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing
Exclusion criteria :
- Active brain metastases
- Myocardial infarction within 6 months of study day 1
- Gastrointestinal (GI) tract disease causing the inability to take oral medication