Stage IV Non Small Cell Lung Cancer whose tumors lack EGFR mutations and ALK fusions MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion criteria at screening for initial therapy : • Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation.(according to version 8 of the IASLC Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology 2016). • Patients must have tumors that lack activating EGFR mutations and ALKfusions. • (WHO)/(ECOG)performance status of 0 or 1 • No prior chemotherapy or any other systemic therapy for Stage IV NSCLC • Adequate organ and marrow function without blood transfusions in the past 28 days, • At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment • Documented radiographic evidence of CR, PR, or SD as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy. • CrCl =51 mL/min calculated by Cockcroft-Gault equation or measured by 24-hour urine collection. • Ability to swallow whole oral medications. Patients not having GI illnesses Please refer to the protocol for rest of incluision criteria 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 131 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 196
Exclusion criteria
Exclusion criteria: Key exclusion criteria at screening for initial therapy : • Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology. • Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease),PARP therapy, or immune-mediated therapy • Active or prior documented autoimmune or inflammatory disorders. • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. • Current or prior use of immunosuppressive medication within 14 days before the first dose of IP • untreated (CNS) metastases and/or carcinomatous meningitis • Active infection. Exclusion criteria to be randomized to maintenance treatment: • Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of durvalumab during initial therapy. Please refer to the protocol for rest of iexclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out the effectiveness of durvalumab combined with olaparib compared to durvalumab alone;Secondary Objective: - To further assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of OS, ORR, and DoR. - To further assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS in the HRRm population. - To assess the PK of durvalumab in combination with olaparib. - To assess disease-related symptoms and HRQoL in patients treated with durvalumab plus olaparib combination therapy compared with durvalumab monotherapy. - To investigate the immunogenicity of durvalumab. Safety objective: To assess the safety and tolerability profile of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy;Primary end point(s): Progression-free survival (PFS) defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression);Timepoint(s) of evaluation of this end point: Tumor imaging will be from date of randomization until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival (OS) defined as time from date of randomization until the date of death by any cause. • Objective response rate (ORR) defined as percentage of patients with an Investigator-assessed response of CR or PR after randomization. • Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression • PFS in HRRm population defined as time from date of randomization until the date of objective radiological disease progression according to Investigator assessment in HRRm population using RECIST 1.1 or death (by any cause in the absence of progression) • Concentration of durvalumab • Disease-related symptoms and HRQoL assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30 and EORTC QLQ-LC13. • Presence of anti-drug antibodies (ADA) for durvalumab • Safety endpoints of AEs, physical examinations, laboratory findings, and vital signs;Timepoint(s) of evaluation of this end point: Assessments will be made periodically until the end of study’ | — |
Countries
Belgium, France, Hungary, Netherlands, Poland, Romania, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Transparency
AstraZeneca Clinical
Outcome results
None listed