Phase 2 N=40 Treatment

Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.

Neuroendocrine Tumours

Bottom Line

View on ClinicalTrials.gov: NCT02698410 ↗

Enrolled (actual)

Serious AEs

22.5%

Results posted

Oct 2020

Primary outcome: Primary: Disease Control Rate (DCR) Assessed Locally at Month 9 — 35.0; 45.2; 45.0 percentage of participants — p=0.2968

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lanreotide (Autogel formulation) and Temozolomide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease Control Rate (DCR) Assessed Locally at Month 9	35.0; 45.2; 45.0	0.2968
SECONDARY DCR Assessed Centrally at Month 9	28.2	—
SECONDARY Median Progression Free Survival (PFS) Assessed Locally and Centrally	37.1; 37.1	—
SECONDARY Median Time to Response (TTR) Assessed Locally and Centrally	NA; NA	—
SECONDARY Median Duration of Response (DOR) Assessed Locally and Centrally	NA; NA	—
SECONDARY Median Time to Progression (TTP) Assessed Locally and Centrally	37.1; 37.1	—
SECONDARY Best Overall Response (BOR) Assessed Locally and Centrally	0; 7.7; 71.8; 0; 20.5; 0	—
SECONDARY Objective Response Rate (ORR) Assessed Locally and Centrally at Months 9 and 12	2.5; 2.5; 5.1; 2.6	—
SECONDARY DCR Assessed Locally and Centrally at Month 12	17.5; 15.4	—
SECONDARY DCR Assessed Locally and Centrally at Month 9 by Carcinoid Type	12.5; 47.6; 27.3; 0; 35.0; 36.4	—
SECONDARY Percentage of Biochemical Responders According to Chromogranin A (CgA) Plasma Levels	27.3; 59.1; 13.6; 37.5; 37.5; 25.0	—
SECONDARY Neuron-Specific Enolase (NSE) and CgA Biomarker Levels	40.0; 15.0; 45.0; 34.3; 22.9; 42.9	—
SECONDARY Influence of Biomarkers Expression on Locally and Centrally Assessed PFS	0.71; 0.66; 0.31; 0.90; 0.12; 1.08	—
SECONDARY Influence of Biomarkers Expression on Locally and Centrally Assessed ORR at Months 9 and 12	—	—
SECONDARY Influence of Biomarkers Expression on Locally and Centrally Assessed DCR at Months 9 and 12	0.90; 0.78; NA; 0.67; 12.00; NA	—
SECONDARY Coefficient of Agreement Between Central and Local Assessment of Tumor Radiological Response at Month 9	0.71	—

Summary

The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months.

Eligibility Criteria

Inclusion Criteria

Histological documented unresectable advanced (locally or metastatic) well or moderately differentiated neuroendocrine tumors of the lung or thymus (typical and atypical carcinoids according to the World Health Organisation (WHO) 2004 criteria);
Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;
Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);
Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);
Adequate liver, renal and bone marrow function.

Exclusion Criteria

Poorly differentiated neuroendocrine carcinoma and mixed Neuroendocrine tumours (NET), according to WHO 2004 criteria
Neuroendocrine tumours other than lung or thymus
Non-neuroendocrine thymic neoplasm
Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit (V1)
Treated with a number of systemic therapy lines > 3 prior to screening visit (V1), and any of the following:
for chemotherapy no more than 1 line prior to V1
for somatostatin analogue no more than 1 line therapy, considered as treatment lasting more than 6 months, prior to V1 no therapy with Temozolomide (TMZ) prior to V1
Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
Received external palliative radiotherapy within the last 28 days prior to screening visit (V1)
Received locoregional therapies (Transarterial embolization, Transcatheter arterial chemoembolization, thermo-ablation with radio-frequency) and Selective internal radiotherapy within 3 months prior to screening visit (V1)
Presence of symptomatic brain metastasis
Subjects with symptomatic cholelithiasis at screening visit (V1)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02698410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.