Participants and neoadjuvant treatment
NSCLC, WOCBP, tumor, cancers, vitiligo, Carcinomas, Neuroendocrine carcinomas, cancer, malignancy, amenorrhea, lung cancer, psoriasis, infectious disease, psychiatric, Anderson Cancer, hypothyroidism, sensorineural hearing impairment/loss, Cancer
VITILIGO, TUMOR, SQUAMOUS CELL SKIN CANCER, PROSTATE, CARCINOMA IN SITU, ONCOLOGY, TYPE I DIABETES MELLITUS, SUPERFICIAL BLADDER CANCER, PATHOLOGY, AUTOIMMUNE DISEASE, CANCER, CARCINOMAS, HYPERSENSITIVITY REACTION, CANCER, DELAYED-TYPE HYPERSENSITIVITY, PSORIASIS, NEUROENDOCRINE CARCINOMA, HYPOTHYROIDISM, GILBERT SYNDROME, HEPATITIS B, LUNG CANCER, HEPATITIS C, DISORDER, CANCERS, VIRUS, CHRONIC INFECTION, DISEASE, INFECTIOUS DISEASE, CONTRAST DYE ALLERGY, NSCLC
Male and female patients were screened, enrolled and treated at MD Anderson Cancer Center. The complete list of inclusion criteria is shown below:Age >18 years.Histologically or cytologically confirmed previously untreated NSCLC. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer are eligible, but pathology must be confirmed before initiating treatment on study. Neuroendocrine carcinomas are not eligible. Carcinomas with neuroendocrine differentiation are eligible.Patients with stage IB ≥4 cm, IIA, IIB or IIIA disease (according to the American Joint Committee on Cancer 7th edition) are eligible for enrollment into arms C and D.Patients with stage IIIA must not have more than one mediastinal LN station involved by tumor.All patients must have LN evaluation of contralateral stations 2 and/or 4 to exclude N3 disease.The patient must be a suitable candidate for surgery, in the opinion of the treating physician.Signed and dated written informed consent must be provided by the patient before admission to the study in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and to the local legislation.Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0–1.Patients must have organ and marrow function as defined below:Absolute neutrophil count ≥1.5 × 10Hemoglobin ≥8.0 g dlPlatelets ≥100 × 10Total bilirubin ≤1.5× upper limit of normal (ULN) (except partients with Gilbert syndrome, who can have total bilirubin <3.0 mg dlAST and ALT ≤3× ULNCreatinine ≤1.5× ULN or calculated creatinine clearance (Cockcroft–Gault formula for creatinine clearance calculation) ≥50 ml minThe complete list of exclusion criteria is shown below:Prior systemic therapy or radiation therapy for treatment of the current lung cancer.Currently receiving cancer therapy (CT, radiation therapy, immunotherapy or biologic therapy) or investigational anti-cancer drug.Pregnant or lactating female.Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU LWOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes.Unwillingness or inability to follow the procedures required in the protocol.Patients with pre-existing sensorineural hearing impairment/loss or newly diagnosed as documented by an audiology assessment performed before study enrollment may not be eligible for cisplatin and may be dispositioned to carboplatin, as determined by the treating physician.Patients with a history of severe hypersensitivity reaction to Taxotere and or polysorbate 80 must be excluded.Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results. Prior malignancy active within the previous 2 years. Patients with locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast with local control measures (surgery and radiation), are eligible.Patients with active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Patients with 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.Patients are permitted to use topical, ocular, intra-articular, intranasal and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if >10 mg per day prednisone equivalents. A brief course of corticosteroids for prophylaxis (for example, contrast dye allergy) or for treatment of non-autoimmune conditions (for example, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.Known positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection.Known history of testing positive for HIV or known AIDS.History of severe hypersensitivity reaction to any monoclonal antibody and/or to study drug components.Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (for example, implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females and condoms for participating males) during and after the trial as detailed below:WOCBP should use an adequate method to avoid pregnancy for 23 weeks after the last dose of investigational drug(s).Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.Women who are not of childbearing potential as well as azoospermic men do not require contraception.Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.Sex and/or gender was not considered in the trial design. Patient characteristics, including self-reported sex, are reported in Table 