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)

Sponsor:

SWOG

Sponsor Study ID:

S2012

CTO #:

103848

NCT Number:

NCT05058651

Phase:

II/III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Bladder; Cervix Uteri; Other Digestive Organ; Other Endocrine System; Prostate

Study Objectives:

Among patients with metastatic extrapulmonary poorly differentiated small cell NEC, to compare overall survival (OS, measured from randomization) in a fixed sequence as follows: a. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3) b. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3) c. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2)

eConsent:

Not available

Study Documents:

Open Study Documents
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