Phase III study of Pemetrexed+Platinum with or without Pembrolizumab in first line (1L) metastatic non-squamous NSCLC.
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]non-squamous non-small cell lung cancer
- Registration Number
- EUCTR2015-003694-15-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 570
•Have a histologically-confirmed or cytologically-confirmed diagnosis of
stage IV (M1a or M1b AJCC 7th edition) nonsquamous NSCLC.
•Have confirmation that EGFR or ALK-directed therapy is not indicated.
•Have measurable disease based on RECIST 1.1 as determined by the
local site investigator/radiology assessment. Target lesions situated in a
previously irradiated area are considered measurable if progression has
been demonstrated in such lesions.
•Have not received prior systemic treatment for their
advanced/metastatic NSCLC. Subjects who received adjuvant or
neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy
was completed at least 12 months prior to the development of
metastatic disease.
•Have provided tumor tissue from locations not radiated prior to biopsy;
formalin-fixed specimens after the subject has been diagnosed with
metastatic disease will be preferred for determination of PD-L1 status
prior to randomization. Biopsies obtained prior to receipt of
adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy
is not feasible.
•Be =18 years of age on day of signing informed consent.
•Have a life expectancy of at least 3 months.
•Have a ECOG performance status of 0 or 1
•Have adequate organ function as indicated by the laboratory values
specified in the protocol
•If female of childbearing potential, have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study
medication.
If the urine test is positive or cannot be confirmed as negative, a serum
pregnancy test will be required.
•If female of childbearing potential, be willing to use an adequate
method of contraception as outlined in the protocol, for the course of the
study through 120 days after the last dose of study medication or
through 180 days after last dose of chemotherapeutic agents as
specified in the protocol.
•If male subject with a female partner(s) of child-bearing potential,
must agree to use an adequate method of contraception as outlined in
the protocol, starting with the first dose of study therapy through 120
days after the last dose of study therapy or through 180 days after last
dose of chemotherapeutic agents as specified in the protocol. Males with
pregnant partners must agree to use a condom; no additional method of
contraception is required for the pregnant partner.
•Subject has voluntarily agreed to participate by giving written informed
consent/assent for the trial. The subject may also provide
consent/assent for Future Biomedical Research. However, the subject
may participate in the main trial without participating in Future
Biomedical Research.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 302
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 268
•Has predominantly squamous cell histology NSCLC. Mixed tumors will
be categorized by the predominant cell type; if small cell elements are
present, the subject is ineligible.
•Is currently participating and receiving study therapy or has
participated in a study of an investigational agent and received study
therapy or used an investigational device within 4 weeks prior to
administration of pembrolizumab.
•Before the first dose of trial treatment:
a)Has received prior systemic cytotoxic chemotherapy for metastatic
disease
b)Has received antineoplastic biological therapy (e.g., erlotinib,
crizotinib, cetuximab) for metastatic disease
c)Had major surgery (<3 weeks prior to first dose)
•Received radiation therapy to the lung that is >30 Gy within 6 months
of the first dose of trial treatment
•Completed palliative radiotherapy within 7 days of the first dose of trial
treatment
•Is expected to require any other form of antineoplastic therapy while
on study
•Has received a live-virus vaccination within 30 days of planned
treatment start. Seasonal flu vaccines that do not contain live virus are
permitted.
•Has clinically active diverticulitis, intra-abdominal abscess, GI
obstruction, peritoneal carcinomatosis
•Has a known history of prior malignancy except if the subject has
undergone potentially curative therapy with no evidence of that disease
recurrence for 5 years since initiation of that therapy.
•Has known active central nervous system (CNS) metastases and/or
carcinomatous meningitis. Subjects with previously treated brain
metastases may participate provided they are clinically stable for at
least 2 weeks and, have no evidence of new or enlarging brain
metastases and also are off steroids 3 days prior to dosing with study
medication. Stable brain metastases by this definition should be
established prior to the first dose of study medication. Subjects with
known untreated, asymptomatic brain metastases may participate but
will require regular imaging of the brain as a site of disease.
•Previously had a severe hypersensitivity reaction to treatment with
another mAb.
•Has a known sensitivity to any component of cisplatin, carboplatin or
pemetrexed
•Has active autoimmune disease that has required systemic treatment in
past 2 years (i.e. with use of disease modifying agents, corticosteroids
or immunosuppressive drugs). Replacement therapy (e.g., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or
pituitary insufficiency, etc.) is not considered a form of systemic
treatment.
•Is on chronic systemic steroids. Subjects with asthma that require
intermittent use of bronchodilators, inhaled steroids, or local steroid
injections would not be excluded from the study.
•Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory
drugs (NSAIDs), other than an aspirin dose = 1.3 g per day, for a 5-day
period (8-day period for long-acting agents, such as piroxicam).
•Is unable or unwilling to take folic acid or vitamin B12
supplementation.
•Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent
or an antibody targeting other immuno-regulatory receptors or
mechanisms. Has participated in any other MK-3475 trial and has been
treated with MK-3475.
Examples of such antibodies include (but are not limited to) antibodies
against IDO, PD-L1, IL-2R, GITR
•Has an active infection requiring therapy
•Has known history of Human Immunodeficiency Vir
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method