Cancer Clinical Trial
Official title:
An Open-label, Multicenter, Phase II Study of PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or Without Actionable Genetic Abnormalities, Detected Using NGS Platform
This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research.
This clinical study is targeted for the patients who harbor KRAS/NRAS mutation or no
actionable genetic abnormalities detected using NGS platform and all patients will be treated
with PDR001. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 21 days.
Patients will be continued to receive study drug until the end of study unless the patients
in disease progression, unacceptable toxicity, withdrawn consent, or by the investigator's
judgment.
The progression of the disease in most patients is defined radiographically and determined
according to RECIST criteria ver. 1.1. If there are patients those who need to be provided
investigational drug beyond predefined end of treatment, additional extended providing of
PDR001 needs the mutual agreement of the investigators and Novartis followed by amendment of
study protocol and contract.
At the investigator's discretion, patients who have the initial RECIST PD may continue
PDR001. At any time, if assessed by the investigator that the patient is no longer benefiting
from PDR001, or the patient experiences a second PD by RECIST, then the patient shall come
off study medication.
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