Back to resultsEfficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors. (ATLANT)
Primary Purpose
Neuroendocrine Tumours
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation) and Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumours
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)
Sites / Locations
- Oncologia Medica - Istituto Oncologico del Mediterraneo - IOM
- Unità Operativa di Oncologia Azienda Ospedaliera Spedali Civili di Brescia
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l., IRCCS
- Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia, IEO
- Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica , Università degli Studi
- Dipartimento di Oncologia Università di Torino Ospedale San Luigi Gonzaga
- S.C di Oncologia Medica, Azienda Ospedaliera Universitaria di Perugia
- U.O. Oncologia - Azienda Ospedaliero-Universitaria Pisana Ospedale S. Chiara
- Oncologia Medica - Istituto Tumori Regina Elena San Gallicano
- OUC di Oncologia- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lanreotide (Autogel formulation) and Temozolomide
Arm Description
Lanreotide ATG 120 mg every 28 days, deep subcutaneous injection for a maximum of 48 weeks, for a total number of 12 injections. Temozolomide 250 mg hard capsules, for 5 consecutive days every 28 days, oral route, for a maximum of 48 weeks.
Outcomes
Primary Outcome Measures
Disease Control Rate (DCR) Assessed Locally at Month 9
Responders were participants who showed disease control according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1 assessed locally by the investigator. The DCR was defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST criteria v1.1. A sensitivity analysis-1 of local DCR was performed excluding participants withdrawn before 9 months with reason other than progressive disease (PD) or missing assessment and considering participants with PD prior or at 9 months as failures. In addition, a sensitivity analysis-2 was performed in order to consider assessments done between 7.5 and 10.5 months as 9 months assessments when 9-month assessment was missing using same methodology, i.e. considering PD prior or at 9 months and participants withdrawn with other or missing reasons as failures.
Secondary Outcome Measures
DCR Assessed Centrally at Month 9
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1. A second set of the original computed tomography (CT) scan images were used for a centralized RECIST v1.1 assessment by an independent radiologist.
Median Progression Free Survival (PFS) Assessed Locally and Centrally
The PFS was defined as the time from the first treatment administration to disease progression according to RECIST criteria v 1.1 or death from any cause. The PFS was assessed locally by the investigator and centrally by an independent radiologist. The distribution of PFS times was estimated using the Kaplan-Meier method. The PFS of participants who were lost to follow-up and those who had not progressed at end of study were censored at the date of the last disease assessment.
Median Time to Response (TTR) Assessed Locally and Centrally
The TTR was defined as the time from first treatment administration to the first objective tumor response (PR or CR according to RECIST criteria v 1.1). The TTR was assessed locally by the investigator and centrally by an independent radiologist. The distribution of TTR was estimated using the Kaplan-Meier method. The TTR of participants who were lost to follow-up or died prior to any objective tumor response were censored at the date of the last disease assessment.
Median Duration of Response (DOR) Assessed Locally and Centrally
The DOR was defined as the time from onset of the first objective tumor response (PR or CR) to objective tumor progression (PD) according to RECIST criteria v 1.1. The DOR was assessed locally by the investigator and centrally by an independent radiologist.
Median Time to Progression (TTP) Assessed Locally and Centrally
The TTP was defined as the time from first treatment administration to the first objective tumor progression (PD) according to RECIST criteria v 1.1. The TTP was assessed locally by the investigator and centrally by an independent radiologist. The distribution of TTP times was estimated using the Kaplan-Meier method. The TTP of participants who were lost to follow-up, and those who had not progressed at end of study were censored at the date of the last disease assessment.
Best Overall Response (BOR) Assessed Locally and Centrally
The BOR was defined as the highest OR achieved by the participant from the time of first treatment until disease progression/recurrence or the end of study according to RECIST criteria v1.1 and was classified as: CR > PR > Non-CR/Non-progressive disease (NCR/NPD) > SD > PD > ND > not evaluable (NE). The BOR was assessed locally by the investigator and centrally by an independent radiologist. Percentages are based on the number of participants in the ITT/Safety population with non-missing observations.
Objective Response Rate (ORR) Assessed Locally and Centrally at Months 9 and 12
The ORR was defined as the percentage of participants with CR or PR according to RECIST criteria v1.1. The ORR was assessed locally by the investigator and centrally by an independent radiologist. The ORR was based on the participants with PD prior to 9 and 12 months with respectively PD at 9 and 12 months, and participants withdrawn before the assessment for reason other than PD or missing as failures.
DCR Assessed Locally and Centrally at Month 12
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1. The DCR was assessed locally by the investigator and centrally by an independent radiologist.
DCR Assessed Locally and Centrally at Month 9 by Carcinoid Type
The influence of type of carcinoid [typical, atypical and undetermined carcinoid neuroendocrine tumors (NET)] on the local and central DCR at 9 months was analysed. Typical carcinoids were defined with absent foci of necrosis and mitotic count < 2 mitoses/2 millimeters^2 (mm^2); atypical carcinoids were defined with presence of foci of necrosis and/or 2 mitoses/2 mm^2 <= mitotic count <= 10 mitoses/2 mm^2; and carcinoid NET were defined as confirmed carcinoid without foci of necrosis and/or mitotic count reported. The DCR was assessed locally by the investigator and centrally by an independent radiologist.
Percentage of Biochemical Responders According to Chromogranin A (CgA) Plasma Levels
Participants with baseline CgA plasma levels greater than the upper limit of normal (ULN) were assessed for a biochemical response. A biochemical responder was defined as a participant who had a decrease of CgA >= 50% compared to baseline, while biochemical SD was defined as a decrease < 50% or an increase <= 25% compared to baseline. Biochemical non-responders had an increase >25% compared to baseline. Baseline was defined as value at Day 1.
Neuron-Specific Enolase (NSE) and CgA Biomarker Levels
The NSE and CgA levels were classified according to ULN as follows: < 1 ULN, 1-2 ULN and > 2 ULN. Baseline was defined as value at Day 1. Percentages are based on the number of participants in the ITT/Safety population who attended the visit with non-missing observations.
Influence of Biomarkers Expression on Locally and Centrally Assessed PFS
The following biomarkers were investigated: Immunohistochemistry assay human somatostatin receptors 2 (SSTR2) including human epidermal growth factor receptor 2 (HER-2) score [0, 1+, 2+, 3+ and positive (+ve) versus negative (-ve)]; hormone receptor score (H-score) (from 0 to 300 as quantitative variable and +ve versus -ve); immunoreactive score (IRS) score (from 0 to 12 and reference for hazard ratio was 0-1). Ki67 index (from 0% to 100% and reference for hazard ratio was 4%-25%). O^6-methylguanine-DNA methyltransferase (MGMT) expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Carcinoid type (typical or NET) was also investigated. Prognostic value of biomarkers expression at screening on PFS were assessed locally and centrally using univariate cox proportional hazard models.
Influence of Biomarkers Expression on Locally and Centrally Assessed ORR at Months 9 and 12
The following biomarkers were investigated: Immunohistochemistry assay SSTR2 including HER-2 score (0, 1+, 2+, 3+); H-score (from 0 to 300 as quantitative variable); IRS score (from 0 to 12). Ki67 index (from 0% to 100%). MGMT expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Less than 5 OR (CR or PR) events were reported, therefore this analysis was not performed.
Influence of Biomarkers Expression on Locally and Centrally Assessed DCR at Months 9 and 12
The following biomarkers were investigated: Immunohistochemistry assay SSTR2 including HER-2 score (0, 1+, 2+, 3+ and +ve versus -ve); H-score (from 0 to 300 as quantitative variable and +ve versus -ve); IRS score (from 0 to 12 and reference for odds ratio was 0-1). Ki67 index (from 0% to 100% and reference for odds ratio was 4%-25%). MGMT expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Carcinoid type (typical or NET) was also investigated. Prognostic value of biomarkers expression at screening on DCR were assessed locally and centrally using univariate logistic regression models.
Coefficient of Agreement Between Central and Local Assessment of Tumor Radiological Response at Month 9
Differences between central radiology review and local investigator review were assessed according to the DCR status and the number of agreements and disagreements between the evaluators (central versus local) along with the p-values from the kappa test. A kappa statistic was used to evaluate the concordance between the central and the local review.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02698410
Brief Title
Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.
Acronym
ATLANT
Official Title
Efficacy and Safety of Lanreotide ATG 120 mg in Combination With Temozolomide in Subjects With Progressive Well Differentiated Thoracic Neuroendocrine Tumors. A Phase II, Multicentre, Single Arm, Open-label Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumours
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanreotide (Autogel formulation) and Temozolomide
Arm Type
Experimental
Arm Description
Lanreotide ATG 120 mg every 28 days, deep subcutaneous injection for a maximum of 48 weeks, for a total number of 12 injections.
Temozolomide 250 mg hard capsules, for 5 consecutive days every 28 days, oral route, for a maximum of 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation) and Temozolomide
Primary Outcome Measure Information:
Title
Disease Control Rate (DCR) Assessed Locally at Month 9
Description
Responders were participants who showed disease control according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria v 1.1 assessed locally by the investigator. The DCR was defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST criteria v1.1. A sensitivity analysis-1 of local DCR was performed excluding participants withdrawn before 9 months with reason other than progressive disease (PD) or missing assessment and considering participants with PD prior or at 9 months as failures. In addition, a sensitivity analysis-2 was performed in order to consider assessments done between 7.5 and 10.5 months as 9 months assessments when 9-month assessment was missing using same methodology, i.e. considering PD prior or at 9 months and participants withdrawn with other or missing reasons as failures.
Time Frame
Up to Month 9; for sensitivity analysis-2, up to 10.5 months
Secondary Outcome Measure Information:
Title
DCR Assessed Centrally at Month 9
Description
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1. A second set of the original computed tomography (CT) scan images were used for a centralized RECIST v1.1 assessment by an independent radiologist.
Time Frame
Up to Month 9
Title
Median Progression Free Survival (PFS) Assessed Locally and Centrally
Description
The PFS was defined as the time from the first treatment administration to disease progression according to RECIST criteria v 1.1 or death from any cause. The PFS was assessed locally by the investigator and centrally by an independent radiologist. The distribution of PFS times was estimated using the Kaplan-Meier method. The PFS of participants who were lost to follow-up and those who had not progressed at end of study were censored at the date of the last disease assessment.
Time Frame
From Day 1 up to end of study, 52 weeks
Title
Median Time to Response (TTR) Assessed Locally and Centrally
Description
The TTR was defined as the time from first treatment administration to the first objective tumor response (PR or CR according to RECIST criteria v 1.1). The TTR was assessed locally by the investigator and centrally by an independent radiologist. The distribution of TTR was estimated using the Kaplan-Meier method. The TTR of participants who were lost to follow-up or died prior to any objective tumor response were censored at the date of the last disease assessment.
Time Frame
From Day 1 up to end of study, 52 weeks
Title
Median Duration of Response (DOR) Assessed Locally and Centrally
Description
The DOR was defined as the time from onset of the first objective tumor response (PR or CR) to objective tumor progression (PD) according to RECIST criteria v 1.1. The DOR was assessed locally by the investigator and centrally by an independent radiologist.
Time Frame
From Day 1 up to end of study, 52 weeks
Title
Median Time to Progression (TTP) Assessed Locally and Centrally
Description
The TTP was defined as the time from first treatment administration to the first objective tumor progression (PD) according to RECIST criteria v 1.1. The TTP was assessed locally by the investigator and centrally by an independent radiologist. The distribution of TTP times was estimated using the Kaplan-Meier method. The TTP of participants who were lost to follow-up, and those who had not progressed at end of study were censored at the date of the last disease assessment.
Time Frame
From Day 1 up to end of study, 52 weeks
Title
Best Overall Response (BOR) Assessed Locally and Centrally
Description
The BOR was defined as the highest OR achieved by the participant from the time of first treatment until disease progression/recurrence or the end of study according to RECIST criteria v1.1 and was classified as: CR > PR > Non-CR/Non-progressive disease (NCR/NPD) > SD > PD > ND > not evaluable (NE). The BOR was assessed locally by the investigator and centrally by an independent radiologist. Percentages are based on the number of participants in the ITT/Safety population with non-missing observations.
Time Frame
From Day 1 up to end of study, 52 weeks
Title
Objective Response Rate (ORR) Assessed Locally and Centrally at Months 9 and 12
Description
The ORR was defined as the percentage of participants with CR or PR according to RECIST criteria v1.1. The ORR was assessed locally by the investigator and centrally by an independent radiologist. The ORR was based on the participants with PD prior to 9 and 12 months with respectively PD at 9 and 12 months, and participants withdrawn before the assessment for reason other than PD or missing as failures.
Time Frame
Months 9 and 12
Title
DCR Assessed Locally and Centrally at Month 12
Description
The DCR was defined as SD, PR or CR according to RECIST criteria v1.1. The DCR was assessed locally by the investigator and centrally by an independent radiologist.
Time Frame
Month 12
Title
DCR Assessed Locally and Centrally at Month 9 by Carcinoid Type
Description
The influence of type of carcinoid [typical, atypical and undetermined carcinoid neuroendocrine tumors (NET)] on the local and central DCR at 9 months was analysed. Typical carcinoids were defined with absent foci of necrosis and mitotic count < 2 mitoses/2 millimeters^2 (mm^2); atypical carcinoids were defined with presence of foci of necrosis and/or 2 mitoses/2 mm^2 <= mitotic count <= 10 mitoses/2 mm^2; and carcinoid NET were defined as confirmed carcinoid without foci of necrosis and/or mitotic count reported. The DCR was assessed locally by the investigator and centrally by an independent radiologist.
Time Frame
Up to Month 9
Title
Percentage of Biochemical Responders According to Chromogranin A (CgA) Plasma Levels
Description
Participants with baseline CgA plasma levels greater than the upper limit of normal (ULN) were assessed for a biochemical response. A biochemical responder was defined as a participant who had a decrease of CgA >= 50% compared to baseline, while biochemical SD was defined as a decrease < 50% or an increase <= 25% compared to baseline. Biochemical non-responders had an increase >25% compared to baseline. Baseline was defined as value at Day 1.
Time Frame
Baseline (Day 1) and Week 4, 12, 24, 36 and 52
Title
Neuron-Specific Enolase (NSE) and CgA Biomarker Levels
Description
The NSE and CgA levels were classified according to ULN as follows: < 1 ULN, 1-2 ULN and > 2 ULN. Baseline was defined as value at Day 1. Percentages are based on the number of participants in the ITT/Safety population who attended the visit with non-missing observations.
Time Frame
Baseline and Weeks 4, 12, 24, 36 and 52
Title
Influence of Biomarkers Expression on Locally and Centrally Assessed PFS
Description
The following biomarkers were investigated: Immunohistochemistry assay human somatostatin receptors 2 (SSTR2) including human epidermal growth factor receptor 2 (HER-2) score [0, 1+, 2+, 3+ and positive (+ve) versus negative (-ve)]; hormone receptor score (H-score) (from 0 to 300 as quantitative variable and +ve versus -ve); immunoreactive score (IRS) score (from 0 to 12 and reference for hazard ratio was 0-1). Ki67 index (from 0% to 100% and reference for hazard ratio was 4%-25%). O^6-methylguanine-DNA methyltransferase (MGMT) expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Carcinoid type (typical or NET) was also investigated. Prognostic value of biomarkers expression at screening on PFS were assessed locally and centrally using univariate cox proportional hazard models.
Time Frame
From Screening period (-4 weeks) up to Week 52
Title
Influence of Biomarkers Expression on Locally and Centrally Assessed ORR at Months 9 and 12
Description
The following biomarkers were investigated: Immunohistochemistry assay SSTR2 including HER-2 score (0, 1+, 2+, 3+); H-score (from 0 to 300 as quantitative variable); IRS score (from 0 to 12). Ki67 index (from 0% to 100%). MGMT expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Less than 5 OR (CR or PR) events were reported, therefore this analysis was not performed.
Time Frame
Screening period, Months 9 and 12
Title
Influence of Biomarkers Expression on Locally and Centrally Assessed DCR at Months 9 and 12
Description
The following biomarkers were investigated: Immunohistochemistry assay SSTR2 including HER-2 score (0, 1+, 2+, 3+ and +ve versus -ve); H-score (from 0 to 300 as quantitative variable and +ve versus -ve); IRS score (from 0 to 12 and reference for odds ratio was 0-1). Ki67 index (from 0% to 100% and reference for odds ratio was 4%-25%). MGMT expression including percentage of +ve nuclei stained and methylated sites and H-score (from 0 to 300 as quantitative variable). For all these categories, higher score indicates a higher expression of biomarkers. Carcinoid type (typical or NET) was also investigated. Prognostic value of biomarkers expression at screening on DCR were assessed locally and centrally using univariate logistic regression models.
Time Frame
Screening period, Months 9 and 12
Title
Coefficient of Agreement Between Central and Local Assessment of Tumor Radiological Response at Month 9
Description
Differences between central radiology review and local investigator review were assessed according to the DCR status and the number of agreements and disagreements between the evaluators (central versus local) along with the p-values from the kappa test. A kappa statistic was used to evaluate the concordance between the central and the local review.
Time Frame
Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Oncologia Medica - Istituto Oncologico del Mediterraneo - IOM
City
Viagrande
State/Province
Catania
ZIP/Postal Code
95029
Country
Italy
Facility Name
Unità Operativa di Oncologia Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l., IRCCS
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia, IEO
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica , Università degli Studi
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Dipartimento di Oncologia Università di Torino Ospedale San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
S.C di Oncologia Medica, Azienda Ospedaliera Universitaria di Perugia
City
Perugia
ZIP/Postal Code
06123
Country
Italy
Facility Name
U.O. Oncologia - Azienda Ospedaliero-Universitaria Pisana Ospedale S. Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Oncologia Medica - Istituto Tumori Regina Elena San Gallicano
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
OUC di Oncologia- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.
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