Clinical trial NCT02259621 (phase 2, status: recruiting)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: nivolumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven non-small-cell lung cancer (core biopsy required).

               -  Squamous or non-squamous histology

               -  Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at
                  SKCCC or MSKCC

               -  Either a formalin fixed paraffin block or a minimum of fifteen 5-micron tissue
                  sections (slides) of tumor biopsy sample must be available for biomarker
                  evaluation (study pathologist must review for adequacy of sampling). This can be
                  obtained from archived tissues, or from a new biopsy if needed.

          -  Stage - High risk NSCLC with resection option for potential cure, as assessed by a
             faculty surgeon at SKCCC or MSKCC. This may include clinical stage IB (≥4cm), II and
             IIIA(see Appendix A). Subjects with N3 nodal involvement are not included.

        ECOG performance status 0-1

        -Adequate organ function as follows:

          -  Leukocytes ≥ 2,000/mm3

          -  Absolute neutrophil count (ANC) ≥ 1000/mm3

          -  Platelet count ≥ 100,000/mm3

          -  Hemoglobin ≥ 9 g/dL

          -  Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥40 mL/min (if using the
             Cockcroft-Gault formula below):

        Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL

        Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL

          -  Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total
             bilirubin < 3.0 mg/dL)

          -  AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 3 times the upper limit of normal

          -  Subjects must have adequate lung function to permit surgical resection determined by
             pre-enrollment pulmonary function tests to include DLCO

               -  The effects of nivolumab on the developing human fetus are unknown. For this
                  reason, women of child-bearing potential (WOCBP) and men must agree to use
                  adequate contraception (hormonal or barrier method of birth control; abstinence)
                  prior to study entry and for the duration of study participation and for up to 23
                  weeks after the last dose of nivolumab. Should a woman become pregnant or suspect
                  she is pregnant while she or her partner is participating in this study, she
                  should inform her treating physician immediately. Sexually active fertile men
                  must use effective barrier birth control if their partners are WOCBP for up to 31
                  weeks after the last dose of nivolumab. WOCBP must have a negative serum or urine
                  pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
                  two weeks of registration. Women must not be breastfeeding.

               -  Patient understands the study regimen, its requirements, risks and discomforts
                  and is able and willing to sign the informed consent form. Voluntary signed and
                  dated IRB/IEC approved written informed consent form in accordance with
                  regulatory and institutional guidelines must be obtained before the performance
                  of any protocol related procedures that are not part of normal patient care.
                  Subjects must be competent to report AEs, understand the drug dosing schedule and
                  use of medications to control AEs.

        Exclusion Criteria:

          -  Subjects are excluded if they have an active, known or suspected autoimmune disease.
             Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus,
             residual hypothyroidism due to autoimmune condition only requiring hormone
             replacement, psoriasis not requiring systemic treatment, or conditions not expected to
             recur in the absence of an external trigger.

          -  Subjects are excluded if they have a condition requiring systemic treatment with
             either corticosteroids (> 10 mg daily prednisone equivalents) or other
             immunosuppressive medications within 14 days of study drug administration. Inhaled or
             topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents
             are permitted in the absence of active autoimmune disease. As there is potential for
             hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a
             predisposition to hepatoxicity should be used with caution in patients treated with
             nivolumab-containing regimen.

          -  Administration of chemotherapy or any other cancer therapy in the pre-operative
             period.

          -  Subjects with active concurrent malignancies are excluded i.e. cancers other than
             NSCLC (except non melanoma skin cancers, in situ bladder, gastric, breast, colon or
             cervical cancers/dysplasia).

          -  Subjects with brain metastasis are excluded from this study, and all patients should
             have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment.

          -  Subjects with a history of symptomatic interstitial lung disease.

          -  Active systemic infection requiring therapy, positive tests for Hepatitis B surface
             antigen or Hepatitis C ribonucleic acid (RNA).

          -  Known positive history or positive test for Human Immunodeficiency Virus or Acquired
             ImmunoDeficiency Syndrome (AIDS).

          -  History of allergy to study drug components.

          -  Women who are pregnant or nursing.

          -  Men with female partners (WOCBP) that are not willing to use contraception.

          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or
             any other antibody targeting T cell co-regulatory pathways).

          -  Underlying medical conditions that, in the Investigator's opinion, will make the
             administration of study drug hazardous or obscure the interpretation of toxicity or
             adverse events.

          -  Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for
             treatment of either a psychiatric or physical (e.g. infectious disease) illness.