Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Inclusion Criteria

• Age > 18
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy.
• Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy.
• Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy
• No limit on number of prior therapies
• Ability to provide written, informed consent
• Patients must be on a stable regimen of treatment for their autoimmune condition without need for addition of new medications or escalating doses of preexisting medications in the previous 12 weeks prior to study entry
• In addition, patients with the following autoimmune diseases must have baseline disease activity scores as follows (please see Appendix A):
• For rheumatoid arthritis: DAS28 < 5.1
• For polymyalgia rheumatica: PMR-AS < 17
• For Sjogrens: ESSDAI < 14
• For ulcerative colitis: SSCAI < 5
• For Crohn's disease: CDAI < 450
• For systemic lupus erythroderma: SLEDAI-2K < 20
• For multiple sclerosis: EDSS < 5.5
• Adequate organ and marrow function as defined by:
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 100,000/mcL
• total bilirubin ≤ 2.5 × institutional upper limit of normal
• AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal, OR
• AST(SGOT)/ALT(SGPT ) ≤5 × institutional upper limit of normal if liver metastases are present
• Creatinine within normal institutional limits OR
• Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
• Non-pregnant and non-nursing.
• Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses > 1 year.
• Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.

Exclusion Criteria

• No chemotherapy or radiotherapy within two weeks of study entry. Prior targeted therapy is allowed as long as at least 5 half-lives have elapsed since last dose.
• All adverse events (other than alopecia) from prior therapy must be resolved to Grade 1 or less.
• Patients who are known to be HIV positive are excluded due to the known immunologic alterations associated with the disease. HIV testing is not required.
• No uncontrolled intercurrent illness such as active infection, or psychiatric illness or social situation that in the judgment of the investigator would limit compliance with study requirements
• No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or pneumonitis requiring treatment with corticosteroids
• No live vaccine within 30 days of start of study treatment
• No carcinomatous meningitis or untreated CNS metastases
• No history of significant cardiac disease or presence of an abnormality in electrocardiograms that, in the investigator's opinion, is medically exclusionary or clinically meaningful
• No other active malignancy
• No known history of or positivity for active hepatitis B or C. HBV DNA and/or HCV RNA must be undetectable and HBsAg must be negative at the time of screening
• No active unstable angina and/or congestive heart failure, or myocardial infarction within 6 months prior to protocol participation