A Phase II Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in Gastroenteropancreatic (GEP) and Thoracic Neuroendocrine Tumor (NET): The LOLA Trial

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano1 site in 1 country69 target enrollmentJune 20, 2020

ConditionsMetastatic Well Differentiated Neuroendocrine Neoplasm Neuroendocrine Tumors

InterventionsCabozantinib Lanreotide

DrugsCabozantinib Lanreotide

Overview

Phase: Phase 2
Intervention: Cabozantinib
Conditions: Metastatic Well Differentiated Neuroendocrine Neoplasm
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrollment: 69
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Phase II trial aiming to assess the safety and activity of the combination of cabozantinib plus lanreotide in gastroenteropancreatic (GEP) and thoracic neuroendocrine tumor (NET): The LOLA trial

Detailed Description

Phase II, multicenter, open-label, non-comparative, non-randomized study with three-stage design

Registry

clinicaltrials.gov

Start Date

June 20, 2020

End Date

November 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•voluntary written informed consent obtained before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care;
•Patients with unresectable, advanced or metastatic neuroendocrine well differentiated GEP-NET (pancreatic NET (G2-G3), Small Intestinal NET, stomach NET, rectum NET) with Ki67 10%.
•Patients with unresectable, advanced or metastatic neuroendocrine well differentiated thoracic NET (typical and atypical lung NET, thymus NET)
•Patients with unresectable, advanced or metastatic neuroendocrine well differentiated unknown primary NET with Ki67 10%.
•Locally advanced or metastatic disease documented as progressive by RECIST v1.
•on CT-scan or MRI at baseline and within 12 months prior to baseline.
•disease that is not amenable to surgery with curative intent;
•presence of at least one measurable target lesion for further evaluation according to RECIST v1.1;
•age ≥18 years;
•eastern Cooperative Oncology Group (ECOG) performance status 0 or 1(see APPENDIX I)

Exclusion Criteria

•Patients with undifferentiated, poorly differentiated GEP-NET, Thoracic or unknown primary NET;
•Previous therapy for advanced disease \> 1 line; any medical adjuvant treatment must have been stopped at least six months before entry into the study;
•Prior treatment with dose superior or equal to 120 mg per month of lanreotide;
•Prior treatment with cabozantinib;
•Prior treatment with any other tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors is permitted. Prior treatment with non-VEGF-targeted angiogenic inhibitors such as Everolimus is permitted;
•Patients who stopped Everolimus or tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors treatment less than 4 weeks prior to the start of the study;
•Patients with concomitant treatment with Interferon;
•Patients previously treated with chemotherapy, loco-regional therapy (e.g., chemoembolization) or interferon with last administration less than 4 weeks prior to the start of the study or with toxicity not resolved to less or equal grade 1 at the start of the study;
•PRRT therapy with last administration less than 6 months prior to inclusion in the study or with toxicity not resolved to less or equal grade 1 at the start of the study;
•diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri;

Arms & Interventions

Cabozantinib+lanreotide

Cabozantinib will be administered orally at a dose of 60 mg/day continuously in combination with Lanreotide 120 mg injection every 28 days. Both treatments will start the same day

Intervention: Cabozantinib

Cabozantinib+lanreotide

Cabozantinib will be administered orally at a dose of 60 mg/day continuously in combination with Lanreotide 120 mg injection every 28 days. Both treatments will start the same day

Intervention: Lanreotide