Phase 2 / Phase 3: testing Atezolizumab for Advanced Extrapulmonary Neuroendocrine Carcinoma
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment.
Official registry: https://clinicaltrials.gov/study/NCT05058651 · National Cancer Institute (NCI) · enrollment listed as 189
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Atezolizumab, Biospecimen Collection, or Carboplatin. The registry lists allocation as randomized. This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
They plan to enroll about 189 people at 266 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)
Interventions: Atezolizumab, Biospecimen Collection, Carboplatin, Cisplatin, Computed Tomography, Etoposide, Magnetic Resonance Imaging, Patient Observation
Primary outcome (registry wording): Overall survival
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)
- Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator
- Participants who have received treatment for brain metastases must have:
- No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
- Discontinued all corticosteroids at least 14 days prior to registration
- Participants with treatment-who have not tried this kind of treatment before brain lesions must have:
- No lesion measuring \> 2.0 cm in size in any axis
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
266 listed- Alaska Women's Cancer Care — Anchorage, Alaska (suspended)
- Cancer Center at Saint Joseph's — Phoenix, Arizona (recruiting)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona (recruiting)
- Kaiser Permanente-Anaheim — Anaheim, California (recruiting)
- Sutter Auburn Faith Hospital — Auburn, California (recruiting)
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California (recruiting)
- Kaiser Permanente-Baldwin Park — Baldwin Park, California (recruiting)
- Kaiser Permanente-Bellflower — Bellflower, California (recruiting)
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California (recruiting)
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California (recruiting)
- Mercy Cancer Center - Carmichael — Carmichael, California (recruiting)
- Mercy San Juan Medical Center — Carmichael, California (recruiting)
FAQ about this NCT record
Is NCT05058651 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05058651?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05058651?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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