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Clinical Trial Summary

This phase III trial compares the effect of atezolizumab with a platinum drug (cisplatin or carboplatin) and etoposide to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide for the treatment of poorly differentiated extrapulmonary (other than the lung) small cell neuroendocrine cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with a platinum drug (cisplatin or carboplatin), may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differeentiated extrapulmonary small cell neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3). II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3). III. 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). SECONDARY OBJECTIVES: I. To compare overall survival (OS), measured from start of observation/maintenance, across arms. II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms. III. To compare objective response rate (ORR = confirmed and unconfirmed partial response [PR] + confirmed and unconfirmed complete response [CR]) across arms among patients with measurable disease at randomization. IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease [SD]) across arms among patients with measurable disease at randomization. V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm. ADDITIONAL OBJECTIVE: I. To bank tumor and blood samples for future biomarker correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1, carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1, and etoposide IV on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive atezolizumab IV over 60 minutes on day 1, carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1, and etoposide IV on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. ARM III: Patients receive carboplatin IV over 60 minutes or cisplatin IV over 60 minutes on day 1 and etoposide IV on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. After completion of study treatment, patients are followed up for 5 years. ;


Study Design


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NCT number NCT05058651
Study type Interventional
Source National Cancer Institute (NCI)
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Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 7, 2021
Completion date October 31, 2024