Study Summary
This trial is comparing the effect of immunotherapy with atezolizumab in combination with standard chemotherapy versus standard therapy alone for the treatment of poorly differentiated extrapulmonary small cell neuroendocrine cancer.
Eligible Conditions
- Neuroendocrine Carcinoma
- Recurrent Extrapulmonary Neuroendocrine Carcinoma
- Metastatic Neuroendocrine Carcinoma
- Advanced Extrapulmonary Neuroendocrine Carcinoma
- Unresectable Neuroendocrine Carcinoma
- Metastatic Extrapulmonary Neuroendocrine Carcinoma
- Unresectable Extrapulmonary Neuroendocrine Carcinoma
- Small Cell Lung Cancer
- Extrapulmonary Small Cell Neuroendocrine Carcinoma
- Small Cell Neuroendocrine Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 5 years from study enrollment
Year 5
Overall survival
Year 5
Progression-free survival
Year 5
Duration of response
Year 5
Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)
Objective response rate (confirmed complete response [CR] and partial response [PR])
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
Trial Design
4 Treatment Groups
Arm III (platinum drug, etoposide, observation)
1 of 4
Arm I (atezolizumab, platinum drug, etoposide)
1 of 4
Arm I (atezolizumab, platinum, etoposide)
1 of 4
Arm II (atezolizumab, platinum drug, etoposide, observation)
1 of 4
Active Control
Experimental Treatment
189 Total Participants · 4 Treatment Groups
Primary Treatment: Cisplatin · No Placebo Group · Phase 2 & 3
Arm I (atezolizumab, platinum drug, etoposide)Experimental Group · 7 Interventions: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Cisplatin, Carboplatin, Etoposide, Atezolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug, Drug, Biological
Arm I (atezolizumab, platinum, etoposide)Experimental Group · 4 Interventions: Cisplatin, Carboplatin, Etoposide, Atezolizumab · Intervention Types: Drug, Drug, Drug, Biological
Arm II (atezolizumab, platinum drug, etoposide, observation)Experimental Group · 8 Interventions: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Cisplatin, Carboplatin, Patient Observation, Etoposide, Atezolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug, Other, Drug, Biological
Arm III (platinum drug, etoposide, observation)ActiveComparator Group · 7 Interventions: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Cisplatin, Carboplatin, Patient Observation, Etoposide · Intervention Types: Procedure, Procedure, Procedure, Drug, Drug, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~670
Computed Tomography
2017
Completed Phase 2
~3410
Magnetic Resonance Imaging
2017
Completed Phase 2
~1100
Platinum
Not yet FDA approved
Carboplatin
FDA approved
Beta-D-Glucose
Not yet FDA approved
Atezolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years from study enrollment
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,071 Previous Clinical Trials
41,128,666 Total Patients Enrolled
1 Trials studying Unresectable Neuroendocrine Carcinoma
96 Patients Enrolled for Unresectable Neuroendocrine Carcinoma
David B ZhenPrincipal InvestigatorSouthwest Oncology Group
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Participants must have a histologically verified, irresectable or metastatic extrapulmonary poorly differentiated NEC which can be evaluated radiographically by CT scan with IV contrast within the last 28 days and according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; all known lesions must be documented on the Baseline Tumor Assessment Form.
There is no sign of advancement on MRI brain or CT head with contrast scans within the last 28 days before registration.
You have abstained from corticosteroids for a minimum of 14 days before registering.
No lesions measuring greater than two centimetres in any direction are present.
MRI brain or CT head with contrast (if unable to have MRI) must show no signs of mass effect, swelling, or other neurological issues within the last 28 days.
A daily dosage of less than two milligrams of dexamethasone (or equivalent to ten milligrams of prednisone) is required for registration.
Applicants with a history of non-metastatic extrapulmonary poorly differentiated NEC, who have undergone prior platinum-based therapy and/or radiation treatment and/or surgery at least 6 months before registering are eligible.
You must stop taking denosumab and switch to a bisphosphonate before joining the study.
You are at least 18 years of age or older.
Participants must have had a Zubrod performance status of two or lower within the preceding four weeks before registering.
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Conditions
Cancer Related
Treatments