Phase 3 Study of AMG 510 versus Docetaxel in NSCLC Patients
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C
IRAS ID
279150
Contact name
Colin Lindsay
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2019-003582-18
Duration of Study in the UK
6 years, 9 months, 12 days
Research summary
A Phase 3 multicentre, randomised, open label, active-controlled study to compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) patients with KRAS p.G12C mutation and to evaluate the efficacy, safety, and tolerability of AMG 510 versus docetaxel in patients with previously treated locally advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation.
KRAS (Kirsten rat sarcoma viral oncogene homolog) is a gene which encodes KRAS protein that, when mutated, sends signals to other cells that make them grow uncontrollably and often develop into cancer. KRAS mutations are common in many types of cancer. Knowing that the KRAS p.G12C mutation is present in your cancer allows the doctors to selectively target the mutation.
The primary objective of the study is to compare the efficacy of AMG 510 versus docetaxel as assessed by progression-free survival (PFS) in previously treated patients with KRAS p.G12C mutated NSCLC. The study will be conducted at approx. 300 sites globally and will consist of a screening period, a treatment period, a safety follow up period and long term follow up period. Approximately 650 patients will be enrolled and randomised 1:1 to receive either AMG 510 or docetaxel. All patients randomised to the AMG 510 group will receive AMG 510 at a starting dose of 960 mg once a day or Docetaxel 75 mg/m administered into a vein over 1 hour every 3 weeks.
Tumour assessment will be conducted by magnetic resonance imaging (MRI) and/or contrast-enhanced computerized tomography (CT) during screening; every 6 weeks from cycle 1 until week 49 and then at 9 week intervals thereafter until progression, start of another anti-cancer therapy, withdrawal of consent, lost to follow up, or death, whichever occurs earliest.
An independent (external to Amgen) data monitoring committee (DMC) will review safety and efficacy data as per DMC charter.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0108
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion