DURVALUMAB for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"-Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening evaluations"}
• {"criterion_text":"-Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). o Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)."}
• {"criterion_text":"-Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up"}
• {"criterion_text":"-Histological or cytological diagnosis of NSCLC"}
• {"criterion_text":"-T1-2N0M0 tumours ≤ 5 cm"}
• {"criterion_text":"-Peripheral tumours"}
• {"criterion_text":"-Medically inoperable patients/at-risk patients or patients refusing surgery"}
• {"criterion_text":"-Received no prior chemotherapy or radiation therapy for NSCLC"}
• {"criterion_text":"-Age > 18 years at time of study entry, no upper age limit"}
• {"criterion_text":"-WHO performance status 0-2"}
• {"criterion_text":"-Adequate normal organ and marrow function as defined below: Haemoglobin ≥ 9.0 g/dL, Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3), Platelet count ≥ 75 x 109/L (>100,000 per mm3), Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) , AST/ALT ≤ 2.5 x institutional upper limit of normal, Serum creatinine CL>30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by chrome-EDTA or Iohexol clearance,"}

Exclusion criteria

• {"criterion_text":"-Centrally located tumours"}
• {"criterion_text":"-Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, 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: o Subjects with vitiligo or alopecia o Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement o Any chronic skin condition that does not require systemic therapy o Subjects without active disease in the last 5 years may be included but only after consultation with the study physician o Subjects with celiac disease controlled by diet alone"}
• {"criterion_text":"-History of primary immunodeficiency"}
• {"criterion_text":"-History of allogeneic organ transplant"}
• {"criterion_text":"-History of hypersensitivity to durvalumab or any excipient"}
• {"criterion_text":"-Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA III-IV), uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent"}
• {"criterion_text":"-Active infection 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). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA"}
• {"criterion_text":"-Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab"}
• {"criterion_text":"-Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy."}
• {"criterion_text":"-Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results"}
• {"criterion_text":"-No regional or distant metastases are allowed (i.e. no stage IIB-IV disease)"}
• {"criterion_text":"-Oxygen usage or a FEV1 < 0.7 L and CO diffusion capacity < 30%"}
• {"criterion_text":"-Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study"}
• {"criterion_text":"-Participation in another clinical study with an investigational product during the last 4 weeks"}
• {"criterion_text":"-Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab"}
• {"criterion_text":"-Second primary residual malignancy. Other malignancy diagnosed and treated > 2 years ago without relapse and deemed to have a low likelihood of relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin < 2 years are allowed, as is other low-grade malignancy with low likelihood of becoming metastatic or impact on survival e.g. low-grade prostate cancer not in need of treatment)"}
• {"criterion_text":"-Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug"}
• {"criterion_text":"-Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid"}

Primary endpoints

• {"endpoint_text":"-time to progression (TTP)","definition_or_measurement_approach":""}

Finland

Latest Decision Or Authorization Date

22-07-2024

Number Of Sites

4

Number Of Participants

6

Sweden

Latest Decision Or Authorization Date

22-07-2024

Number Of Sites

7

Number Of Participants

80

Norway

Latest Decision Or Authorization Date

24-07-2024

Number Of Sites

4

Number Of Participants

20

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden