Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
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ClinicalTrials.gov Identifier: NCT02943798 |
Recruitment Status : Unknown
Verified October 2016 by Zhou Zhen, Shanghai Chest Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Large Cell Neuroendocrine Carcinoma | Drug: etoposide plus carboplatin Drug: Paclitaxel plus carboplatin | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
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Experimental: Group A
Patients will be administered with etoposide plus carboplatin as first-line treatment.
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Drug: etoposide plus carboplatin
etoposide is administered by venus with a dose of 100mg/m2 from day 1 to3, and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Other Name: VP-16 |
Experimental: Group B
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
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Drug: Paclitaxel plus carboplatin
Paclitaxel is administered by venus with a dose of 175 mg/m2 from day 1 and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Other Name: Taxol |
- Progression-free survival [ Time Frame: 6 months ]Interval from randomization to disease progression, or untolerated toxicity
- Tumor response [ Time Frame: 2 months ]Percentage of complete response and partial response

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943798
Contact: Zhen Zhou, MD | jenniferzhou1116@163.com |
Study Chair: | Zhen Zhou, MD | Shanghai Chest Hospital |
Responsible Party: | Zhou Zhen, Chief Physician, Shanghai Chest Hospital |
ClinicalTrials.gov Identifier: | NCT02943798 |
Other Study ID Numbers: |
Chest003 |
First Posted: | October 25, 2016 Key Record Dates |
Last Update Posted: | October 25, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy |
Carcinoma Carcinoma, Neuroendocrine Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Adenocarcinoma Neoplasms, Nerve Tissue Paclitaxel |
Etoposide Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |