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Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma

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ClinicalTrials.gov Identifier: NCT02428764
Recruitment Status : Unknown
Verified October 2017 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 29, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nimotuzumab Drug: Gemcitabine Drug: Carboplatin Procedure: Surgery Phase 2

Detailed Description:
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Nimotuzumab, a human anti-EGFR monoclonal antibody, has shown its efficacy in the treatment of head/neck squamous cell carcinoma, nasopharyngeal carcinoma as well as lung cancer. This study is studying neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Induction Nimotuzumab Plus Gemcitabine and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Squamous Cell Lung Carcinoma
Study Start Date : April 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Intervention group
Patients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery.
Drug: Nimotuzumab
Nimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8

Drug: Gemcitabine
Gemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8.
Other Name: Gemzar

Drug: Carboplatin
carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1.
Other Name: CBP

Procedure: Surgery
Patients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists.




Primary Outcome Measures :
  1. Resectability rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of participants with perioperative complications [ Time Frame: 1 year ]
  2. Event-free survival [ Time Frame: 2 years after the last patient is enrolled ]
    Event-free survival was assessed from diagnosis to disease recurrence/metastasis/progression or death as a result of any cause.

  3. Overall survival [ Time Frame: 2 years after the last patient is enrolled ]
    Overall survival was assessed from diagnosis to death as a result of any cause.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • Target population is unresectable stage III squamous cell lung carcinoma.
  • Written informed consent provided.
  • Male and female patients aged ≥18 years, ≤75 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Life expectancy ≥12 weeks.
  • Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  • Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

  • Known severe hypersensitivity to nimotuzumab or any of the excipients of this product.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  • Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
  • Patients with prior radiotherapy
  • History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
  • Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over).

Information from the National Library of Medicine

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): NCT02428764


Contacts
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Contact: Si-Yu Wang, MD +86 20 87343439 wsysums@163.net

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Si-Yu Wang, Doctor    +86 20 87343439    wsysums@163.net   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Si-Yu Wang, MD Guangdong Province Association Study of Thoracic Oncology
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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02428764    
Other Study ID Numbers: GASTO1010
wsy006 ( Other Identifier: Guangdong Province Association Study of Thoracic Oncology )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Nimotuzumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological