A Phase II study of Concurrent Chemoradiation plus Durvalumab (MEDI4736) followed by Surgery followed by Adjuvant Durvalumab (MEDI4736) in medically operable patients with surgically resectable Stage III (N2) Non-Small Cell Lung Cancer
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: Non-Small Cell Lung Cancer
Age: Between 18 - 100 Years
Gender: Male or Female
Histological or cytological confirmation of NSCLC (Adenocarcinoma, Squamous Cell Carcinoma, Large Cell Carcinoma).
Must have resectable and medically operable stage III (N2) NSCLC with biopsy-proven N2 disease.
Individuals cannot have contralateral neck or mediastinum nodal involvement.
Individuals must not have distant metastasis.
Demonstrate adequate organ function.
History of a major surgical procedure (as defined by investigator) within 28 days prior to the first dose of study drug. NOTE: Local surgery for isolated lesions for palliative intent is acceptable.
History of another primary malignancy except for a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study drug, b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, c) adequately treated carcinoma in situ without evidence of disease.
History of leptomeningeal disease.
Persons who have small cell carcinoma.
Persons who do not meet the Stage IIIA NSCLC classification criteria outlined above.
Presence of superior vena cava syndrome.
Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.
Active central nervous system (CNS) metastases.
Treatment with any investigational agent within 28 days prior to registration for protocol therapy.
Patients should not have received any prior therapy for the current diagnosis of NSCLC. Treatments done for previously diagnosed malignancies are permitted. Prior therapy with a PD-1, PD-L1 (including Durvalumab), PD-L2 or CTLA-4 inhibitor or a lung cancer-specific vaccine therapy are not permitted.
Presence of metastatic disease (stage IV NSCLC) is not allowed.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician
• Patients with celiac disease controlled by diet alone
Interstitial lung disease or history of pneumonitis requiring treatment with corticosteroids
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• Steroids as premedication for hypersensitivity reactions (e.g., paclitaxel premedication and CT scan premedication)
History of psychiatric illness or social situations that would limit compliance with study requirements
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator.
Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required.
Has received a live vaccine within 30 days prior to planned start of study therapy.
NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
History of allograft or allogeneic bone marrow transplant.
Contact the research team to learn more about this study.
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