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


Sponsor :

Amgen


Phase :

III


Ligne :

2de line


Traitement :

AMG 510 Vs Docetaxel


Spécificités :

Have documentation of KRAS p.G12C mutation confirmed by central testing through the current protocol or Amgen Study 20190294 prior to enrollment.


Site :

CHUV, HUG


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