Purpose of this Study
We are doing this study to compare the usual treatment for neuroendocrine carcinomas to using atezolizumab plus the usual treatment. Another purpose is to compare using atezolizumab just at the beginning of treatment to continuing it beyond the initial treatment.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with extrapulmonary, poorly differentiated neuroendocrine carcinoma (NEC)
- Have disease that is unresectable or metastatic and not eligible for definitive therapy
- Do not have symptomatic central nervous system (CNS) metastases
- Do not have diagnosed or suspected leptomeningeal disease
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 groups:
- Group 1: If you are in this group, you will get induction treatment (main treatment for your cancer) with atezolizumab, platinum (choice of carboplatin or cisplatin based on what your doctor feels is best for you), and etoposide. All study drugs will be given via IV (into a vein). Atezolizumab and platinum are each given as a single dose on day 1. Etoposide is given once daily on days 1 through 3. This will be repeated every 3 weeks for four cycles of treatment. A "cycle" is a period of three weeks, so you will receive treatment for 12 weeks. If there is no worsening of your cancer based on your scans or your clinical condition after induction therapy, you will then receive up to one year of maintenance (treatment aimed to delay your cancer from worsening) atezolizumab alone given once every 3 weeks for 17 cycles.
- Group 2: If you are in this group, you will get induction treatment (main treatment for your cancer) with atezolizumab, platinum (choice of carboplatin or cisplatin based on what your doctor feels is best for you), and etoposide. All study drugs will be given via IV (into a vein). Atezolizumab and platinum are each given as a single dose on day 1. Etoposide is given once daily on days 1 through 3. This will be repeated every 3 weeks for four cycles of treatment. A cycle is a period of three weeks, so you will receive treatment for 12 weeks. After induction therapy, the study doctor will continue to observe your condition.
- Group 3: If you are in this group, you will get induction treatment (main treatment for your cancer) with platinum (choice of carboplatin or cisplatin based on what your doctor feels is best for you) and etoposide. All study drugs will be given via IV (into a vein). The platinum drug is given as a single dose on day 1. Etoposide is given once daily on days 1 through 3. This will be repeated every 3 weeks for four cycles of treatment. A cycle is a period of three weeks, so you will receive treatment for 12 weeks. After induction therapy, the study doctor will continue to observe your condition.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
S2012 Randomized Phase II/III Trial of First Line Platinum/Etoposide with or Without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)
Principal Investigator
Tucker
Coston
Protocol Number
PRO00117487
NCT ID
NCT05058651
Phase
II/III
Enrollment Status
Pending Open to Enrollment