Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

Phase 2

• Conditions: Pulmonary Large Cell Neuroendocrine Carcinoma
• Interventions: Drug: etoposide plus carboplatin; Drug: Paclitaxel plus carboplatin

• Registration Number: NCT02943798
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

Detailed Description

The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic.

Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-22
• Study First Submitted QC: 2016-10-22
• Last Update Submitted: 2016-10-22
• Study First Posted: 2016-10-25
• Last Update Posted: 2016-10-25
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology
• Estimated life expectancy over 3 months
• Performance status 0,1,2
• Signed informed consent
• Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine < 2.5 mg/dL (221 mmol/L); serum AST or ALT <5.0 x upper limit of normal (ULN); serum total bilirubin <2.0 mg/dL (34 mmol/L)

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Exclusion Criteria

• History of chemotherapy or molecular targeted therapy
• Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy
• Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy
• Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > or = to 1 year
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
• Pregnant or lactating
• Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	etoposide plus carboplatin	Patients will be administered with etoposide plus carboplatin as first-line treatment.
Group B	Paclitaxel plus carboplatin	Patients will be administered with paclitaxel plus carboplatin as first-line treatment.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	6 months	Interval from randomization to disease progression, or untolerated toxicity

Secondary Outcome Measures

Name	Time	Method
Tumor response	2 months	Percentage of complete response and partial response