Stage I Non-small cell lung cancer (NSCLC) that has been treated with Stereotactic Body Radiotherapy (SBRT).
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations • Histological or cytological diagnosis of NSCLC • Stage I tumours = 5 cm • Peripheral tumours suitable for a fractionation schedule of 15 Gy x 3 • Medically inoperable patients or patients refusing surgery • Received no prior chemotherapy or radiation therapy for NSCLC • Age > 18 years at time of study entry, no upper age limit • WHO performance status 0-2 • Adequate normal organ and marrow function • Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 166
Exclusion criteria
Exclusion criteria: • Centrally located tumours • Oxygen usage or a FEV1 5 years ago without relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin < 5 years are allowed) • Mean QT interval corrected for heart rate (QTc) =470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia’s Correction • Current or prior use of immunosuppressive medication within 28 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 • Active or prior documented autoimmune disease within the past 2 years • Active or prior documented inflammatory bowel disease, history of primary immunodeficiency, history of allogenic organ transplant, history of tuberculosis • Uncontrolled intercurrent Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether adjuvant immunotherapy with durvalumab administered after curatively intended SBRT in stage I NSCLC will increase time to progression;Secondary Objective: To assess whether adjuvant immunotherapy with durvalumab administered after curatively intended SBRT in stage I NSCLC will: ? Increase overall survival (1-, 2- 3-years) ? Increase disease free survival (DFS) ? Increase cause specific survival (1-, 2- 3-years) ? Increase time to progression depending on PDL1 expression ? Impact on relapse pattern ? Impact on local control ? Impact on Quality of life ? Impact on toxicity ;Primary end point(s): Time to Progression (TTP);Timepoint(s) of evaluation of this end point: TTP is measured from the date of randomization to date of progression and will be assessed after 53 events (i.e. progression) have been recorded which is estimated to happen one year after the inclusion of the last subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (1-, 2- 3-years) - measured from date of randomization to death. Disease free survival (DFS) - measured from date of randomization to relapse or death. Cause specific survival (1-, 2- 3-years) - measured from date of randomization to death due to NSCLC. TTP by PDL1 expression - TTP analysed according to PDL1 expression on biopsy taken before study entry. Relapse pattern, Local, regional or distant relapse (organ specific). Local control -defined as no local progression at 36 months follow up Quality of life, Lung cancer symptom scale - LCSS at 6, 12, and 20 months Toxicity, according to CTC version 4.0 at every follow up ;Timepoint(s) of evaluation of this end point: Toxicity with AE’s and SAE’s and will be followed continuously. In addition in-depths toxicity analyses are planned after inclusion of 50 and 100 patients. As for the other secondary endpoints they will be assessed when the number of events for the primary analysis have been reached, see E.5.1.1. | — |
Countries
Sweden
Contacts
Public ContactClinical trial unit
Sahlgrenska University Hospital
Outcome results
None listed