Lung Cancer Clinical Trials

• Provide written informed consent/assent for the trial. The trial consent includes future biomedical research.

• Male/female participants who are at least 18 years of age on the day of signing informed consent

• Patients with histologically confirmed diagnosis of advanced non-small cell lung cancer.

• Have a life expectancy of 12 weeks

• Participants who progressed from chemo(platinum-based)-immunotherapy, immunotherapy single agent or immuno-immuno combination therapies as front or second line of therapy.

• Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:

‣ Has received at least 2 doses of an approved anti-PD-1/L1 mAb.

⁃ Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression (as defined in 4.c).

⁃ Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.

• Progressive disease is determined according to RECISTv1.1.

∙ This determination is made by the investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.

• Have measurable disease per RECIST v1.1 as assessed by the investigator and site radiologist.

• Have provided archival tumor sample or newly obtained core or excisional biopsy of tumor lesion. Formalin fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides and the pretreatment biopsy is discretionary if suitable archival tissue sample is available.

• Adequate organ function. (must be within 10 days prior to start of study intervention)

• Absolute neutrophil counts (ANC) 1500/mm3

• Platelet count 100,000/mm3

• Hemoglobin 9 g/dL without need for hematopoietic growth factor or transfusion support.

• Serum creatinine 1.5 x ULN (Upper Limit of Normal), or 24-hour creatinine clearance 30 cc/min. (note: creatinine clearance need not be determined if the baseline serum creatinine is within normal limits)

• Serum bilirubin 1.5 ×ULN OR direct bilirubin ULN for participants with total bilirubin levels \>1.5 × ULN.

• Aspartate amino transferase (AST) 2.5 ULN or 5XULN for subjects with liver metastases.

• Alanine amino transferase (ALT) 2.5 ULN or 5XULN for subjects with liver metastases.

• Alkaline phosphatase 2.5 X ULN of liver fraction if 2.5 X ULN

• Serum albumin 2.5g/dL.

• Prothrombin time (PT) 1.5 x ULN and INR 1.3

• Partial thromboplastin time (PTT) 1.5 ULN.

• ECOG 0-1.

• Allowing patients who received over 30 Gy radiation therapy within 6 months of pembrolizumab treatment given the safety data from stage III patient received immunotherapy after concurrent chemotherapy and radiation.

• Female subjects of childbearing/reproductive potential must have a negative serum pregnancy test within 72 hours prior to receiving the treatment of study medication.

• Female subjects of childbearing potential and their partners must be willing to use a highly effective method of contraception as outlined in 5.5.2- Contraception, for the course of study through 183 days after the last dose of study medication.

• Male subjects and their partners of childbearing potential must agree to use a highly effective method of contraception as outlined in 5.5.2- Contraception, starting with the first dose of study medication through 183 days after the last dose of therapy and refrain from donating sperm during this period.

⁃ Note: both for male and female subjects, abstinence is acceptable if this is life style or preferred method of contraception