Untersuchung von Pembrolizumab gegenüber Chemotherapien auf Platin-Basis bei Patienten mit fortgeschrittenem, PD-L1-positivem, bisher unbehandeltem, Nichtkleinzelligem Lungenkrebs

Biological: pembrolizumab;Drug: carboplatin;Drug: paclitaxel;Drug: pemetrexed

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion criteria:

- Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSCLC

- PD-L1 positive tumor

- Measureable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

- Life expectancy of at least 3 months

- No prior systemic chemotherapy for the treatment of the participant's advanced or
metastatic disease (treatment with chemotherapy and/or radiation as part of
neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior
to diagnosis of advanced or metastatic disease)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate organ function

- No prior malignancy, with the exception of basal cell carcinoma of the skin,
superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or
has undergone potentially curative therapy with no evidence of that disease recurrence
for 5 years since initiation of that therapy

- Submission of formalin-fixed diagnostic tumor tissue (in the case of participants
having received adjuvant systemic therapy, the tissue should be taken after completion
of this therapy)

- Female participants of childbearing potential must have a negative urine or serum
pregnancy test and must be willing to use two adequate barrier methods of
contraception or a barrier method plus a hormonal method starting with the screening
visit through 120 days after the last dose of pembrolizumab or 180 days after the last
dose of chemotherapeutic agents used in the study

- Male participants with a female partner(s) of child-bearing potential must be willing
to use two adequate barrier methods of contraception from screening through 120 days
after the last dose of pembrolizumab or 180 days after the last dose of
chemotherapeutic agents used in the study

Exclusion criteria:

- Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or is echinoderm
microtubule-associated protein-like 4(EML4) gene/anaplastic lymphoma kinase (ALK) gene
fusion positive

- Currently participating or has participated in a study of an investigational agent or
using an investigational device within 4 weeks of the first dose of study therapy

- No tumor specimen evaluable for PD-L1 expression by the central study laboratory

- Squamous histology and received carboplatin in combination with paclitaxel in the
adjuvant setting

- Is receiving systemic steroid therapy =3 days prior to the first dose of study therapy
or receiving any other form of immunosuppressive medication with the exception of
daily steroid replacement therapy

- The NSCLC can be treated with curative intent with either surgical resection and/or
chemoradiation

- Expected to require any other form of systemic or localized antineoplastic therapy
while on study

- Any prior systemic cytotoxic chemotherapy, biological therapy or major surgery within
3 weeks of the first dose of study therapy; received lung radiation therapy >30 Gy
within 6 months of the first dose of study therapy

- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other
antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

- Known central nervous system metastases and/or carcinomatous meningitis

- Active autoimmune disease that has required systemic treatment in the past 2 years

- Had allogeneic tissue/solid organ transplantation

- Interstitial lung disease or history of pneumonitis that has required oral or IV
steroids

- Has received or will receive a live vaccine within 30 days prior to the first study
therapy (seasonal flu vaccines that do not contain live vaccine are permitted)

- Active infection requiring intravenous systemic therapy

- Known history of human immunodeficiency virus (HIV)

- Known active Hepatitis B or C

- Regular user (including "recreational use") of any illicit drugs or had a recent
history (within the last year) of substance abuse (including alcohol)

- Pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the study