Patients with non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic 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: Inclusion criteria: - At least 18 years of age at the time of signing the informed consent form. - Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing. - Patients eligible for second- or later-line therapy, who must have received an anti PD 1/PD-L1 containing therapy and a platinum-doublet Regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior anti-PD-1/PD-L1 therapy. - Suitable for a new tumour biopsy. For Module 10 and Module 11 only: If in agreement with the sponsor study physician, a patient may be exempt from a biopsy at pre-screening if a tumour tissue sample is obtained after progression on prior anti-PD-(L)1 therapy and = 3 months prior to pre-screening; a tumour sample taken within the previous 24 months is acceptable if no such sample is available. - ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks. - Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed. - Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. 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 285 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 285
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Patients whose tumour samples have targetable alterations in EGFR and/or ALK are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded. - Active or prior documented autoimmune or inflammatory disorders. - Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). - Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control. - Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients or history of severe hypersensitivity reactions to other monoclonal antibodies. - Patient has spinal cord compression or symptomatic brain metastases. - Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-? ligand (RANKL) inhibitors for the treatment of bone metastases. -history of active primary immunodeficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain an assessment of the efficacy of each treatment by evaluation of objective response rate.;Secondary Objective: To assess the efficacy of each therapy by evaluation of tumour response (Disease control rate, Best percentage change in tumour size, Duration of response, Progression free survival) and Overall Survival.;Primary end point(s): Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival (OS) Endpoints based on RECIST 1.1 including: • Disease control rate (DCR) • Best percentage change in tumour size • Duration of response (DoR) • Progression free survival (PFS);Timepoint(s) of evaluation of this end point: Until death due to any cause or progression for PFS, DoR or DCR | — |
Countries
Austria, Canada, France, Germany, Korea, Republic of, Spain, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed