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Phase 1 Study of Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

Phase 1
18 Years
65 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Phase 1 Study of Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer

Altered expression or constitutive activation of the epidermal growth factor receptor
(EGFR/HER1/erbB1) commonly occurs in primary NSCLC, and is often a critical factor in
progressive growth and resistance to normal mechanisms of cell death. Epidermal growth
factor receptor expression in lung cancer has been correlated with tumor aggressiveness.
Clinical trials already suggest that EGFR targeted therapy may improve the antitumor
activity of chemotherapy for treatment of lung carcinoma. Monoclonal antibodies specific to
EGFR can be combined safely and effectively with chemotherapy. Nimotuzumab (hR3) is a
humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the
antibody has shown potent antitumor activity. A previous phase II study in children with
high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in
prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects
were reported. Nimotuzumab (hR3) in combination with radiotherapy for treatment of locally
advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor
response, and was accompanied by a favourable safety profile.

This is a dose-escalation study of Nimotuzumab. Nimotuzumab in combination with chemotherapy
will be administered to the patients with advanced NSCLC. The patients' blood test and liver
and renal function tests will be monitored weekly, a physical exam and reassessment of the
tumor will be performed and every 6 weeks. When the total result is the CR or PR, the
results of the 6th, 12th, 18th and the 22th week should be compared.

Inclusion Criteria:

- Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC.
Disease must be newly diagnosed .

- Presence of at least 1 uni-dimensionally measurable index lesion,with the longest
diameter ≥ 20 mm using conventional computer tomography(CT)/magnetic resonance
imaging(MRI)scan or ≥ 10 mm using spiral computed tomography scan.

- Age > 18 and < 65, with ECOG performance status 0-1,and Life expectancy of more than
3 months.

- functions of major organs (haemogram, heart, liver, kidney) are basically normal,
White blood count ≥3.5 x 109/L with neutrophils ≥1.5 x 109/L, platelet count≥100 x
109/L, and hemoglobin ≥100g/L. Total bilirubin ≤1.5 times upper limit of normal (ULN)
range; alkaline phosphatase(ALP)≤ 2.5 times ULN or ≤5 times ULN (liver metastasis);
Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN (liver
metastasis). serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.

- both female and male patients must use adequate methods of contraception.

- without other malignancy history, except curative carcinoma in situ of cervix and
skin basal cell carcinoma.

- willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

Exclusion Criteria:

- Previous radiotherapy(except the radiotherapy of brain metastasis), Previous
chemotherapy or anticancer biotherapy , Participation other clinical trials within 1
month prior to inclusion in the trial.

- With only unmeasureable lesion, ie, hydrothorax, ascites, lymphangitis carcinomatous,
diffuse liver metastasis, bony metastasis; no measureable lesion or the lesion could
not be determined.

- Pregnant or breast-feeding women or using a prohibited contraceptive method.

- With Symptomatic brain metastasis not controlled.

- with an uncontrolled seizure disorder, or active centre neurological disease, or
Psychiatric disease affected cognitive ability; physiogenic or pathological
dystrophinopathies, chronic diarrhea, cachexia.

- with significant history of cardiac disease, i.e., congestive heart failure, angina
requiring medication, uncontrolled cardiac ventricular arrythmias, heart valve
disease, serious myocardial infarction, uncontrolled hypertension.

- With other serious internal diseases or uncontrolled infection.

- With drug addition,ie,drug-taking,drug-taking for long time;with AIDS.

- With organ transplantation,or using adrenocortical hormone or immunosuppressive
agents for long time.

- With history of serious allergic or allergy.

- Not fit for the clinical trial judged by the investigator.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

Outcome Time Frame:

within study period

Safety Issue:


Principal Investigator

Yuankai Shi, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

June 2010

Related Keywords:

  • Non-Small Cell Lung Cancer
  • nimotuzumab
  • non-small cell lung cancer
  • chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms