Lung neuroendocrine tumours
Conditions
Interventions
None listed
Sponsors
Ipsen Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria (1) Provision of written informed consent prior to any study related procedures, (2) Subjects aged * 18 years, (3) Have metastatic and/or unresectable pathologically confirmed well-differentiated, typical or atypical neuroendocrine tumour of the lung, (4) Histologic evidence of well differentiated NETs of the lung (typical and atypical according to the WHO criteria evaluated locally), (5) Has a mitotic index
Exclusion criteria
Exclusion criteria: Exclusion criteria (1) Poorly differentiated or high grade carcinoma, or neuroendocrine tumours not of lung origin, (2) Subjects with multiple endocrine neoplasia type 1 (MEN 1), (3) Has been treated with an SSA at any time prior to randomization, except if that treatment was for less than 15 days (e.g. peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment was received more than 6 weeks prior to randomization, (4) Has been treated with Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization, (5) Has been treated for lung NET with chemotherapy* within 4 weeks of randomization (whatever the number of cycles), (6) Has been treated with more than two lines of chemotherapy * for lung NET, (* cytotoxic chemotherapy or molecular targeted therapy or interferon) (7) Treated with surgery within 6 weeks prior to randomization, (8) Previous local therapy (e.g. chemo-embolization, bland, or radio-embolization) is allowed if completed > 6 weeks prior to randomization. For subjects who received local therapy prior to randomization, there must be documented growth of measurable disease within the embolization field prior to study, (9) Symptomatic subjects requiring SSA for symptom management (please also note the exclusion criteria No. 3), (10) Subjects with known ectopic production of adrenocorticotropic hormone (ACTH) or other hormonal secreting subjects allowed * ONLY if symptoms adequately controlled without SSAs, (11) Subjects on concomitant Growth Hormone (GH) antagonist, cyclosporine or bromocriptine (12) Inadequate bone marrow function as per investigator*s judgement, (13) Severe renal insufficiency as defined by a calculated creatinine clearance 2 x ULN, AST, ALT or Alk Ph >5xULN, lipase, amylase >2xULN, (15) Serum albumin 8.5%, (20) Abnormal findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, would compromise the subject*s safety or the outcome of the study, (21) Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years, (22) Pregnant or lactating women or those of childbearing potential age and not practicing a medically acceptable method for birth control, (23) Subjects who have participated in any therapeutic clinical study/received any investigational agent within 30 days of randomization. (24) Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would compromise patient safety or the outcome of the study (25) Uncontrolled hypothyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Progression-free survival (PFS) for subjects randomized in LAN group, assessed by central review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes in either the double blind phase, or in the open label period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints * Progression-free survival (PFS), assessed by central review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes during the double-blind phase, * Progression-free survival (PFS), assessed by local review using RECIST v1.1 criteria every 12 weeks, defined as the time from randomization to disease progression or death from any causes during the double-blind phase, * ORR: objective response rate of CR or PR measured by RECIST v1.1 criteria every 12 weeks until the Post Treatment/Early Withdrawal Visit during the double- blind phase, * Time to treatment failure during the double-blind phase, defined as the time from randomization to disease progression [defined as the minimum (time to event according to central review, time to event according to local review)] using RECIST v1.1, death, consent withdrawn, an AE, protocol deviations, lost to follow-up, the appearance of carcinoid syndrome or other hormone related syndrome necessitating the initiation of SSAs (rescue octreotide and/or LAR SSA), or initiation of anticancer treatment, * Mean changes from Baseline in biomarker CgA at Week 8, Week 12 and every 12 weeks thereafter until the Post DB and in the OL treatment phases, * Proportion of subjects with decrease in CgA *30% at Week 8, in the population of subjects with an elevated CgA (*2 x ULN) at Baseline during the double-blind and the OL treatment phases, * Change in QoL, as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) questionnaire from Baseline to Week 12, every 12 weeks and at the Post Treatment /Early Withdrawal Visit and in OL Extension Treatment and Follow-up Phases, * Time to QoL deterioration, defined by a decrease from baseline in EORTC QLQ-C30 score of at least10 points during the double-blind, the OL treatment and during the follow-up phases | — |
Countries
Netherlands
Outcome results
None listed