A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer.

1. Spinal cord compression or brain metastases unless asymptomatic or stable for at least 2 weeks prior to start of study treatment.

2. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia grade 2) at the time of starting study treatment.

3. Any evidence of severe or uncontrolled systemic diseases. Screening for chronic conditions is not required.

4. Woman of childbearing potential (WOCBP) not protected by highly-effective contraceptive method(s) of birth control, and/or who are unwilling or unable to be tested for pregnancy.

5. Pregnant or breastfeeding woman

6. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement.

7. Active or severe autoimmune disorders, including rheumatoid arthritis

8. Exclusion related to Tuberculosis (TB):

* Active TB or a history of incompletely treated TB regardless of screening Quantiferon result

* Quantiferon positive patients (no active disease) are excluded from the study unless the following conditions are met:

* Patients with a history of prior documented completed chemoprophylaxis for latent tuberculosis infection (eg, acceptable treatments include 9 months of isoniazid 300 mg oral daily or equivalent proven regimen per local guidelines) or treatment of active tuberculosis infection (TBI) who has obtained consultation with a specialist to rule out active TBI or the need to receive further treatment.

* Patients with no prior history of chemoprophylaxis for latent TBI or treatment for active TBI but have obtained consultation with a specialist to initiate an appropriate regimen of chemoprophylaxis, based on local epidemiology and applicable guidelines and have demonstrated compliance and tolerated treatment for 1 month.

Consultations with and prior approval from IND sponsor are required in either of the aforementioned scenarios.

* Clinically significant abnormality consistent with prior/active TB infection based upon chest radiograph with at least posterior-anterior view (See Section 10.8.1). Additional lateral view is recommended but not required.

* Suspected extra-pulmonary TB infection regardless of screening Quantiferon result.

* Patients at high risk of contracting TB, such as close contact with individuals with active or latent TB.

* Patient who received Bacille Calmette Guerin -vaccination within 12 months prior to screening.

9. Patients with a history of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).

10. Patients with fever (\>38°C) associated with infection, or chronic, persistent, or recurring infection(s) requiring active treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit or other frequent recurrent infections deemed unacceptable as per Investigator judgment.

11. Patients with uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) greater than 9% at the screening visit.

12. Patients with non-healed or healing skin ulcers.

13. Patients who received any live, attenuated vaccine within 3 months prior to the baseline visit, such as varicella-zoster, oral polio or rubella vaccines.

14. Patients who are positive for hepatitis B surface antigen (HBsAg) or are positive for total hepatitis B core antibody (HBcAb) with negative hepatitis B surface antibody (HBsAb) or are positive for both HBcAb and HBsAb with presence of HBV DNA at screening. E 25. Patients who are positive for hepatitis C antibody (HCV Ab).

15. Patients who are positive for human immunodeficiency virus (HIV) antibody test at screening or who previously had a positive HIV antibody test, or who are suspected to be positive for HIV.

16. Patients with a history of recurrent herpes zoster or active herpes zoster.

17. Patients with a history of prior articular or prosthetic joint infection.

18. Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.

19. Prior or current history of other significant concomitant illness(es) that, according to Investigator's judgment, would adversely affect the patient's participation in the study. These include, but are not limited to, cardiovascular (including Stage III or IV cardiac failure according to the New York Heart Association classification), renal, neurological (including demyelinating disease), active infectious diseases, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary, non-malignant lymphoproliferative disease or other lymphatic disease(s).

20. Patients who have had surgery within 4 weeks prior to the screening visit or with planned surgery during the course of the study.

21. Patients with a history of a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug and known hypersensitivity to any constituent of the sarilumab product.

22. Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.

23. Cognitively impaired adults.

24. Uncontrolled or significant heart disease, such as long QTc interval greater than 480ms on baseline EKG, NYHA III/IV heart failure or uncontrolled arrhythmia.

What this study is about