Limited Disease Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10041069 Term: Small cell lung cancer limited stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IMFINZI® 50 mg/ml
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DURVALUMAB
Other descriptive name: MEDI4736
Concentration unit: mg/ml milligram(s)/millili
Sponsors
Universitätsmedizin Mainz, Interdisziplinäres Zentrum klinische Studien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following criteria will be considered for enrollment to the trial: 1. Signed and dated informed consent of the subject must be available before start of any specific trial procedures 2. Male or female = 18 years 3. Histological confirmed limited disease small cell lung cancer (stage 2 and 3; T2-4, N1-3, M0 according UICC8 criteria), if primarius is not eligible as RECIST1.1 target lesion (in cases with T1a and T1b) at least one lymph node must meet RECIST1.1 criteria for target lesion (=15 mm short axis) 4. Availability of tumor tissue or fresh tumor material for translational research by central lab testing 5. ECOG PS 0 – 1 6. At least one measurable lesion according RECIST 1.1 7. Body weight > 30 kg 8. Adequate normal organ function a. Hemoglobin = 9.0 g/dL b. Absolute neutrophil count (ANC) = 1.5 x109/L c. Platelet count = 100 x109/L d. AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal e. Serum Bilirubin = 1.5 x institutional upper limit of normal f. Estimated glomerular filtration rate (eGFR) = 30 mL/min for Carboplatin, =60 mL/min for Cisplatin, calculated by the Cockcroft-Gault formula 9. Life expectancy of at least 12 weeks in the discretion of the investigator 10. Ability of subject to understand nature, importance and individual consequences of clinical trial 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 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
Exclusion criteria: 1. Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV) 2. Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy 3. History of allogenic organ transplantation 4. Active or prior documented autoimmune or inflammatory disorder (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: a. Patients with vitiligo or alopecia b. Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement c. Patients with any chronic skin condition that not required systemic therapy d. Patients without active disease in the last 5 years may be included but only after consultation with the study physician e. Patients with celiac disease controlled by diet alone 5. Uncontrolled intercurrent illness (i.e. active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious chronic gastrointestinal conditions (i.e. diarrhea), psychiatric illness) 6. History of another primary malignancy in the last 5 years, except adequately treated non-melanoma skin cancer, adequately treated carcinoma in situ (without evidence of disease) 7. History of leptomeningeal carcinomatosis, or brain metastases 8. Known HIV positive and/or 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. 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. 9. Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion: a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) b. Systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 10. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP 11. Participation in another clinical trial with an investigational product within the last 30 days (unless during follow-up period of an interventional study) 12. Known hypersensitivity to one of the ingredients 13. Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial 14. Pregnancy, lactation and contraception a. Women who are pregnant, nursing or who plan to become pregnant while in the trial b. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and for the drug out washout period (90 days after last dose of Durvalumab and/or 6 months after last dose of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Superior efficacy in the Durvalumab treatment group versus control group measured by progression-free survival (PFS) after 18 months.;Secondary Objective: Superior efficacy in the Durvalumab treatment group versus control group by means of overall survival (OS), Quality of life (QoL), overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS) at any other tumor assessments, Safety and Tolerability.;Primary end point(s): Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only.;Timepoint(s) of evaluation of this end point: 18 months after first dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival (PSF) after other assessments Overall survival (OS) Overall response rate (ORR) Disease control rate (DCR) Safety and Tolerability Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D;Timepoint(s) of evaluation of this end point: at different timepoints | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Thomas Wehler
Universitätsklinikum Gießen Marburg
Outcome results
None listed