Exploratory phase II trial of intravenous (IV) Pembrolizumab MK-3475 as second or further
line with advanced Non-small cell Lung Cancer (NSCLC) who have failed to a prior treatment
with anti-PDL1 drug.
Pembrolizumab 200 mg ,Q3W, IV infusion, Day 1 of each 3 week cycle will be administered until
This is a multi-center exploratory phase II trial of intravenous (IV) Pembrolizumab MK-3475
as second or further line with advanced Non-small cell Lung Cancer (NSCLC) who have failed to
a prior treatment with anti-PDL1 drug.
110 patients will be enrolled in this trial to examine the efficacy and outcomes of these
In addition to the usual procedures in a phase II study (evaluation of response, toxicity,
etc.) special attention will be paid in this trial to the molecular assessment in biological
Subjects will receive Pembrolizumab at a fixed dose of 200 mg every 3 weeks (Q3W). Subjects
will be evaluated with radiographic imaging to assess response to treatment. Investigators
will make all treatment-based decisions using the Immune-Related Response Criteria (irRC).
However, for determination of overall response rate (ORR) and progression-free survival
(PFS), the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be used.
Adverse events will be monitored throughout the trial and graded in severity according to the
guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version
4.0. Treatment with Pembrolizumab will continue until documented disease progression,
unacceptable adverse event(s), intercurrent illness that prevents further administration of
treatment, investigator's decision to withdraw the subject, subject withdraws consent,
noncompliance with trial treatment or procedure requirements, or administrative reasons.
After the end of treatment, each subject will be followed for a minimum of 30 days for
adverse event monitoring (serious adverse events will be collected for up to 90 days after
the end of treatment unless the subject starts a new anticancer therapy between days 31 and
90). Subjects will have post-treatment follow-up for disease status, including initiating a
non-study cancer treatment and experiencing disease progression, until death, withdrawing
consent, or becoming lost to follow-up.
Participation in this trial will be dependent upon supplying tumor tissue from a newly
obtained formalin-fixed specimen from locations not radiated prior to biopsy. The specimen
will be evaluated at a central laboratory facility for expression status of PD-L1 in a
prospective manner. Only subjects whose tumors express PD-L1 as determined by the central
laboratory facility will be eligible for inclusion in this study. Also it is highly recommend
to send archival tumor tissue from the patient.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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