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 - LOLA Trial

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: gastroenteropancreatic (GEP) and thoracic neuroendocrine tumor (NET)
Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
Enrollment: 69
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

January 20, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Each patient must meet all of the following inclusion criteria to be enrolled in the study:
•\-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performance of any study\-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care;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\.1\. 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)

•\-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;