Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer

Cohort A: Received any prior systemic therapy for cancer treatment.

Cohort B: May not have received more than one cycle of platinum doublet given with or without an anti-PD-1 or anti-PD-L1 immunotherapeutic.

Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline from adverse events due to previous therapies). Patients with ≤Grade 2 neuropathy may be eligible.

Note: If patient received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.

Received prior radiotherapy within 2 weeks of start of study treatment. Patients 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.

Patients may not receive or have received any radiation therapy at the biopsy sites.

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

Note: Patients 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.

Has had an allogeneic tissue/solid organ transplant.

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \> 10 mg prednisone daily or any other form of immunosuppressive therapy within 7 days prior to Day 1.

Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Prior treatment with a cancer vaccine.

Prior treatment with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).

Received a live vaccine within 30 days prior to Day 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.

Known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to Day 1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.

Known additional malignancy that is progressing or has required active treatment within the past 3 years.

Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to Day 1.

Note: Patients 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.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in the study.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.

Active autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids (prednisone dose of 10 mg or less per day is allowed), 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.

Known history of, or any evidence of active, non-infectious pneumonitis.

A woman of childbearing potential who has a positive urine pregnancy test within 72 hours prior to treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.

Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Has a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection.

Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.

Known history of active tuberculosis (TB).

Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.

Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.

What this study is about