PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities

Inclusion Criteria:

• Subjects with histologically or cytologically confirmed, stage IV or recurrent NSCLCthat carries a KRAS/NRAS mutation or no actionable mutation, which are identified byNGS.

• Squamous cell carcinoma and non-squamous cell carcinoma will be enrolled with 1:1ratio for efficacy analysis according to histology

• Subjects who did not treated with prior anti-PD-1 antibody nor anti-PD-L1 antibodies

• ECOG performance status of 0 to 2

• Male or female; ≥ 18 years of age

• Patients those who showed disease progression after one or two priorplatinum-containing regimen

• Patients who have received prior platinum-containing adjuvant, neoadjuvant, ordefinitive chemoradiation for locally advanced disease are eligible, provided thatprogression has occurred ≥ 12 months from last therapy.

• Subjects with at least one measurable lesion (using RECIST 1.1 and irRC criteria)

• Availability of tumor tissue biopsy for biomarker analysis. Archival tissue can beused. Fine-needle aspirates will not be acceptable.

• Subjects who meet the following criteria:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

• Platelet count ≥100 x 10^9/L

• Serum creatinine ≥ 1.5 x upper limit of normal (ULN)

• AST (SGOT) and ALT (SGPT) ≥ 3 x upper limit of normal (ULN) (If there is LiverMetastasis ≥ 5 x upper limit of normal (ULN))

• Total bilirubin≥1.5 x upper limit of normal (ULN)

• Life expectancy of ≥ 12 weeks on C1D1

• Provision of written informed consent prior to any study specific procedures

Exclusion Criteria:

• Patients who harboring EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK)rearrangement will not be eligible for this trial.

• Patients who have received more than 3 lines of prior systemic therapy, includingcytotoxic agent or targeted agent

• Previous treatment with immune oncologic agents

• Any major operation or irradiation within 4 weeks of baseline disease assessment

• Subjects with symptomatic central nervous system (CNS) metastases who areneurologically unstable or have required increasing doses of steroids within the 2weeks prior to study entry to manage CNS symptoms

• Subjects with history of leptomeningeal metastasis

• Other co-existing malignancies or malignancies diagnosed within the last 3 years withthe exception of basal cell carcinoma or cervical cancer in situ. Any cured cancerthat is considered to have no impact in PFS and OS for the current NSCLC such asthyroid cancer.

• Subjects with an uncontrolled major cardiovascular disease (including AMI within 12months, unstable angina within 6 months, over NYHA class III congestive heart failure,congenital long QT syndrome (Corrected QT (QTcF) >470 ms using Fridericia's correctionon the screening ECG), 2° or more AV Block and uncontrolled hypertension)

• Pregnant or lactating female

• Evidence of any other significant clinical disorder or laboratory finding that makesit undesirable for the patient to participate in the study

• History of severe hypersensitivity reactions to other monoclonal antibodies, which inthe opinion of the investigator may pose an increased risk of serious infusionreaction.

• Active, known or suspected autoimmune disease or a documented history of autoimmunedisease, including ulcerative colitis and Crohn's disease (Patients with vitiligo,type I diabetes mellitus, residual hypothyroidism due to autoimmune condition onlyrequiring hormone replacement, psoriasis not requiring systemic treatment, orconditions not expected to recur in the absence of an external trigger are permittedto enroll).

• Patient has history of interstitial lung disease or interstitial pneumonitis,including clinically significant radiation pneumonitis (i.e., affecting activities ofdaily living or requiring therapeutic intervention).

• Patient has peripheral neuropathy greater than grade 2

• Active HBV or HCV infection, HBV carrier without detectable HBV DNA is not excluded.

• Known history of testing positive for Human Immunodeficiency Virus (HIV) infection

• Any medical condition that would, in the investigator's judgment, prevent thepatient's participation in the clinical study due to safety concerns, compliance withclinical study procedures or interpretation of study results.

• Patients requiring chronic treatment with systemic steroid therapy or anyimmunosuppressive therapy, other than replacement-dose steroids in the setting ofadrenal insufficiency. Topical, inhaled, nasal and ophthalmic steoids are notprohibited.

• Use of any live vaccines against infectious disease within 4 weeks of initiation ofstudy treatment.

• Women of child-bearing potential, unless they are using highly effective methods ofcontraception during dosing and for 150 days after the last dose of study treatment.

• Sexually active males unless they use a condom during treatment and for 150 days afterstopping study treatment .