Clinical Trials /

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

NCT02428764

Description:

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.

Related Conditions:
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GASTO1010
  • SECONDARY ID: wsy006
  • NCT ID: NCT02428764

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
NimotuzumabIntervention group
GemcitabineGemzarIntervention group
CarboplatinCBPIntervention group

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Intervention groupExperimentalPatients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery.
  • Nimotuzumab
  • Gemcitabine
  • Carboplatin

Eligibility 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).
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Resectability rate
Time Frame:3 months
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun Yat-sen University

Last Updated

October 9, 2017