NSCLC MedDRA version: 20.0 Level: HLGT Classification code 10038666 Term: Respiratory and mediastinal neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Bavencio
Product Code: [NA]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Avelumab
CAS Number: 1537032-82-8
Current Sponsor code: NA
Concentration unit:
Sponsors
A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with histologically confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression. Subjects must have progressed after an acceptable therapy defined as follows: a. Subjects must have progressed during or after a minimum of 2 cycles of 1 course of a platinum-based combination therapy or immunotherapy or a combination of both administered for the treatment of metastatic disease. A history of continuation (use of a non-platinum agent from initial combination) or switch (use of a different agent) maintenance therapy is permitted provided there was no progression after the initial combination. A switch of agents during treatment for the management of toxicities is also permitted provided there was no progression after the initial combination. OR b. Subjects must have progressed within 6 months of completion of a platinum-based adjuvant, neoadjuvant, or definitive chemotherapy, or concomitant chemoradiation regimen for locally advanced disease. Subjects with non-squamous cell NSCLC of unknown EGFR mutational status or ALK rearrangement will require testing (local laboratory). Subjects with a tumor that harbors an activating EGFR mutation or ALK rearrangement will not be eligible. ECOG PS of 0 to 1 at trial entry. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: Systemic anticancer therapy administered after disease progression during or following a platinum-based combination. Subjects with non-squamous cell NSCLC whose disease harbors EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial. Subjects of unknown ALK and/or EGFR mutation status will require testing at screening. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of the trial treatment. All subjects with brain metastases, except those meeting the following criteria: a. Brain metastases have been treated locally, and b. No ongoing neurological symptoms that are related to the brain localization of the disease. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy (OS) of avelumab and cetuximab combined in the second line treatment of patients with metastatic NSCLC.;Secondary Objective: To demonstrate superiority with regard to the objective response rate (ORR) of avelumab and cetuximab combined in the second line treatment of patients with metastatic NSCLC. To demonstrate superiority with regard to progression free survival (PFS) of avelumab and cetuximab combined in the second line treatment of patients with metastatic NSCLC. To determine the safety and tolerability of avelumab and cetuximab combined in the second line treatment of patients with metastatic NSCLC.;Primary end point(s): The primary endpoint for the trial is OS time, defined as the interval from enrollment to death for every cause.;Timepoint(s) of evaluation of this end point: The survival follow-up continue a maximum of 5 years after the last subject receives the last dose of avelumab and cetuximab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The overall response rate (ORR) according to RECIST 1.1 Progression free survival (PFS) according to RECIST 1.1 The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS. ;Timepoint(s) of evaluation of this end point: 60 months | — |
Countries
Italy
Contacts
Public ContactDipartimento Internistica Clinica e
Azienda Ospedaliera Universitaria Seconda Università degli Studi di Napoli
Outcome results
None listed