A study on the efficacy and safety of cisplatin/etoposide and concomitant radiotherapy in combination with durvalumab, an immunotherapy, in patients with local limited small cell lung cancer
- Conditions
- Limited Disease Small Cell Lung Cancer
- Registration Number
- 2024-513433-20-00
- Lead Sponsor
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Brief Summary
Superior efficacy in the Durvalumab treatment group versus control group measured by progression-free survival (PFS) after 18 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruitment ended
- Sex
- Not specified
- Target Recruitment
- 105
Signed and dated informed consent of the subject must be available before start of any specific trial procedures
Ability of subject to understand nature, importance and individual consequences of clinical trial
Male or female ≥ 18 years
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)
Availability of tumor tissue or fresh tumor material for translational research by central lab testing
ECOG PS 0-1
At least one measurable lesion according RECIST 1.1
Body weight > 30 kg
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
Life expectancy of at least 12 weeks in the discretion of the investigator
Extensive disease small cell lung cancer (Tx, Nx, M1; stage IV)
Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP
Participation in another clinical trial with an investigational product within the last 30 days (unless during follow-up period of an interventional study)
Known hypersensitivity to one of the ingredients
Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial
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 cisplatin and etoposide))
Patients who are legally institutionalized
Major surgical process within 28 day prior first dose of IMP and/or Radiochemotherapy
History of allogenic organ transplantation
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
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)
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)
History of leptomeningeal carcinomatosis, or brain metastases
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Overall survival (OS)
Overall response rate (ORR) Overall response rate (ORR)
Disease control rate (DCR) Disease control rate (DCR)
Safety and Tolerability Safety and Tolerability
Progression-free survival (PSF) after other assessments Progression-free survival (PSF) after other assessments
Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30, QLQ-LC13 and EQ-5D
Trial Locations
- Locations (17)
Marienhaus Klinikum Mainz GmbH
🇩🇪Mainz, Germany
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
🇩🇪Hemer, Germany
Rostock University Medical Center
🇩🇪Rostock, Germany
Asklepios Klinik Gauting GmbH
🇩🇪Gauting, Germany
Sana Klinikum Offenbach GmbH
🇩🇪Offenbach Am Main, Germany
Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪Giessen, Germany
Klinikum Ernst von Bergmann gGmbH
🇩🇪Potsdam, Germany
Kliniken der Stadt Koeln gGmbH
🇩🇪Cologne, Germany
Klinikverbund Allgaeu gGmbH
🇩🇪Immenstadt I. Allgäu, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Scroll for more (7 remaining)Marienhaus Klinikum Mainz GmbH🇩🇪Mainz, GermanyAndreas BudahnSite contact06131575831526baerbel.kaesberger@marienhaus.de