Study on Adding the Immunotherapy Drug Atezolizumab to Standard Chemotherapy for Advanced Neuroendocrine Cancers Outside the Lung

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05058651

Provider View

This clinical trial is testing whether adding the immunotherapy drug atezolizumab to standard chemotherapy can improve treatment for advanced neuroendocrine cancers that start outside the lung. The study also looks at whether continuing atezolizumab after initial treatment offers additional benefits.

Patient Parameters

Program Overview

This study is exploring if combining the immunotherapy drug atezolizumab with standard chemotherapy drugs (cisplatin or carboplatin and etoposide) can better treat advanced neuroendocrine cancers that originate outside the lung. These cancers may have spread to nearby tissues or other parts of the body. The trial also examines if continuing atezolizumab after the initial treatment phase is more effective than stopping it. Atezolizumab may help the immune system attack cancer cells and prevent them from growing and spreading. The chemotherapy drugs work by killing or slowing the growth of cancer cells. The study aims to see if this combination works better than chemotherapy alone.

Description

The study has three main groups:

  • Group 1: Patients receive atezolizumab with chemotherapy (cisplatin or carboplatin and etoposide) for four cycles, followed by atezolizumab alone for up to 17 cycles if the cancer does not progress or cause severe side effects.

  • Group 2: Patients receive atezolizumab with chemotherapy for four cycles, then are monitored without further treatment for one year.

  • Group 3: Patients receive only chemotherapy for four cycles, then are monitored without further treatment for one year.

All patients will have regular CT or MRI scans and blood tests during the study. After completing the treatment, patients will be followed up for five years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of poorly differentiated neuroendocrine carcinoma that started outside the lung.
  • Cancer must be advanced or metastatic and not suitable for surgery or other definitive treatments.
  • Must have disease that can be evaluated by scans.
  • Must be 18 years or older.
  • Must have a good performance status, meaning able to carry out daily activities with minimal assistance.
  • Must have adequate blood counts and organ function based on specific medical tests.
  • Must not have had prior treatment for advanced or metastatic neuroendocrine cancer, except for one cycle of platinum-based chemotherapy.
  • Must not have received certain immune therapies or other specific treatments for neuroendocrine cancer.
  • Must not have severe allergies to the study drugs.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Must agree to participate in specimen banking for future research.
  • Must provide informed consent to participate in the study.

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