a. Not a woman of childbearing potential (WOCBP)
b. A WOCBP who agrees to use two adequate barrier methods or a barrier method plus a
hormonal method during the treatment period and for at least 120 days after the last dose of
study therapy. Such methods of contraception, or true abstinence from heterosexual activity,
when this is in line with the preferred and usual lifestyle of the subject, are required (periodic
abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods and
withdrawal are not acceptable methods of contraception).
9. If male subject with a female partner(s) of child-bearing potential, must agree to use an effective
contraception method based on the recommendation of the investigator or a gynecologist,
starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Males with pregnant partners must agree to use a condom; no additional method of
contraception is required for the pregnant partner.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the
subject.
10. All subjects must sign written informed consent.
11. Able to operate the NovoTTF-200T system independently or with the help of a caregiver.

1. Mixed small cell and NSCLC histology.
2. EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene
rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion directed
therapy is indicated or planned for other targeted therapy, where such testing and therapy is
locally approved and available. Source documentation of the applicable driver mutations should
be available at the site. Note: For subjects enrolled who are known to have a tumor of
predominantly squamous histology, molecular testing for EGFR mutation, ALK translocation and
ROS1 and/or RET gene rearrangements, and/or METex14 skipping mutation, and/or NTRK1/2
gene fusion will not be required as this is not standard of care and is not part of current diagnostic
guidelines.
3. Has received systemic therapy for metastatic disease.
4. Had major surgery <3 weeks prior to randomization
5. Received radiation therapy to the lung that is > 30 Gy within 6 months of randomization.
6. Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered
from all radiation-related toxicities, not require corticosteroids, and not have had radiation
pneumonitis. A 1- week washout is permitted for palliative radiation ( <2 weeks of radiotherapy)
to non-CNS disease.
7. Is expected to require any other form of antineoplastic therapy while on study.
8. Has a known additional malignancy that is progressing or has required active treatment within
the past 3 years.

Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or
carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially
curative therapy are not excluded.
9. Has untreated or symptomatic Central Nervous System (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate provided they were
treated before randomization and are clinically stable and without requirement of steroid
treatment for at least 3 days prior to randomization.
10. 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.
11. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing
exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy
within 7 days prior randomization. Subjects with asthma that require intermittent use of
bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the
study.
12. Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small
molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to
randomization. Examples of such antibodies include (but are not limited to) antibodies against
IDO, PD-L1, IL-2R, GITR.
13. Participation in another clinical study with an investigational agent or device during the 4 weeks
prior to randomization.
Note: Participants who have entered the follow-up phase of an investigational study may
participate as long as it has been 4 weeks after the last dose of the previous investigational
agent.
14. Concurrent treatment with other experimental treatments for NSCLC while in the study.
15. Significant comorbidity which is expected to affect the subject prognosis or ability to receive the
study therapy:

a) History of significant cardiovascular disease unless the disease is well controlled.
Significant cardiac disease includes second/third-degree heart block; significant ischemic heart
disease; poorly controlled hypertension; congestive heart failure of the New York Heart
Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but
ordinary activity results in fatigue, palpitation or dyspnea).
b) History of arrhythmia that is symptomatic or requires treatment. Subjects with atrial fibrillation
or flutter controlled by medication are not excluded from participation in the study.
c) Any serious underlying medical condition (including active infection) that would impair the
ability of the subject to receive protocol therapy.
d) History of any psychiatric condition that might impair the subject ability to understand or
comply with the requirements of the study or to provide consent.
e) Known medical condition that , in the investigator’s opinion , would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety
results

16. Implanted pacemaker, defibrillator, or other electrical medical devices in the torso.
17. Known allergies or hypersensitivity to medical adhesives, hydrogel.
18. Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab,
cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) .
19. Pregnant or breastfeeding (all subjects of childbearing potential must use effective contraception
method based on the recommendation of the investigator or a gynecologist for up to 120 days
after the last dose of pembrolizumab and through 180 days after last dose of chemotherapy).
20. Admitted to an institution by administrative or court order.
21. Any medical contraindication to treatment with platinum-based doublet chemotherapy or
pembrolizumab as listed in the local labelling.

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