A Phase II randomized Study to evaluate the efficacy and safety of Cisplatin or Carboplatin / Etoposide and concomitant Radiotherapy combined with Durvalumab followed by Maintenance Therapy with Durvalumab versus Cisplatin or Carboplatin / Etoposide and concomitant Radiotherapy in Patients with limited disease Small Cell Lung Cancer.

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR17 sites in 1 country105 target enrollmentSeptember 3, 2024

DrugsMEDI4736 IMFINZI 50 mg/mL concentrate for solution for infusion.ETOPOSIDE (SP-4-2)-cis -diamminedichloroplatinum Cis-diamminedichloroplatinum CARBOPLATIN CISPLATIN CDDP

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Enrollment: 105
Locations: 17
Primary Endpoint: Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only
Status: Active, not recruiting
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Superior efficacy in the Durvalumab treatment group versus control group measured by progression-free survival (PFS) after 18 months

Registry

euclinicaltrials.eu

Start Date

September 3, 2024

End Date

TBD

Last Updated

12 months ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Responsible Party

Principal Investigator

Sponsor contact point clinical trials

Scientific

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Progression-free survival (PFS) after 18 months according to RECIST1.1 as well as iRECIST for Durvalumab group only

Secondary Outcomes

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