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Advanced Non-Small Cell Lung CancerPhase 2NCT00983047

Nimotuzumab Plus Docetaxel in Chemotherapy-Refractory/Resistant Patients With Advanced Non-Small-Cell Lung Cancer

A Phase 2 study testing Nimotuzumab and Docetaxel in people with Advanced Non-Small Cell Lung Cancer, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Nimotuzumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Aug 2009to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological/cytological confirmed Non-small cell lung cancer
  • EGFR expression is positive (Immunohistochemistry)
  • Locally advanced or advanced NSCLC patients(Stage IIIb \ IV)
  • Patients must have had progressive disease after only one prior chemotherapy regimen.This regimen must have been platinum-based.(For the patients who received new adjuvant chemotherapy or adjuvant chemotherapy, only disease free survival within 9 months will be eligible to enrollment).
  • The last dose of chemotherapy must be finished at least 3 weeks before the study, the acute toxicity of chemotherapy must be recovery.
  • The patients previously received radiotherapy could be recruited. (bone marrow influenced by radiotherapy should be less than 25% of the total quantity of general bone marrow ,and the patients didn't receive the whole pelvis radiation, last radiotherapy must be finished at least 4 weeks before the enrollment. )
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  • Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging, or computed tomography in at least one dimension with longest diameter to be recorded as ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT.
  • ECOG performance status 0-2.
  • Life expectancy ≥ 12 weeks.
  • Adequate organic function must be according with the following:
  • Barrow: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, Haemoglobin ≥ 90g/L;
  • Liver function: BIL ≤ 1.5 x ULN, ALP, AST and ALT≤ 3x ULN or ≤ 5 ULN (Liver metastasis);
  • Renal function: Ccr ≥ 45ml/min;
  • No history of clinically significant or uncontrolled cardiac disease, normal electrocardiogram(ECG).
  • Use of an effective contraceptive method for patients of both genders during study and after the end of 3 months, female subjects must be non breast feeding period and serum or urine pregnancy test should be negative.
  • Signed informed consent and submit to the organization of research

Who cannot join

  • Brain metastasis and with symptom
  • Previously treatment regimen including:Docetaxel, anti EGFR monoclonal antibody,anti-angiogenesis targeted medicine,small molecule tyrosine kinase inhibitor(TKIs)
  • Receiving other anti-cancer medicine treatment during the study
  • Uncontrolled pleural effusion、seroperitoneum、pericardial effusion
  • Serious illness or other malignancies diagnosed within the past five years.
  • Patients with any serious active infection
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  • The second primary malignant tumor
  • Serious accompanying disease would influenced the study (such as cardiac disease,Diabetes mellitus etc)
  • Contraindication of hormone therapy
  • Previous definable peripheral neuropathy and with symptom
  • Do not sign informed consent form

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University School of Oncology, Beijing Institute for Cancer Research, Beijing Cancer Hospital

    Beijing, 100142

Other trials in China

About this study

Official title: Phase II Study of Nimotuzumab Plus Docetaxel in Chemotherapy-refractory/Resistant Patients With Advanced Non-small-cell Lung Cancer

Nimotuzumab is a humanized monoclonal anti-body targeting the epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has demonstrated a unique clinical profile, where anti-tumor activity was observed in absence of severe skin, renal, gastrointestinal mucosa toxicities commonly associated with EGFR-targeting antibodies. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in many countries. The investigators compared docetaxel plus nimotuzumab with docetaxel alone in chemotherapy-refractory/resistant patients with advanced EGFR-positive non-small-cell lung cancer to assess the efficacy and safety.

Read the detailed description

Nimotuzumab and Docetaxel will be administered to the patient until disease progression or unacceptable toxicity had occurred.Docetaxel was administered every 3 weeks 75mg/m2; Nimotuzumab treatment at 200mg per week,at least 12 weeks.The patients'hematology and biochemistry examination will be monitored weekly, a physical exam and assessment of the tumor will be performed and every 6 weeks. The patients will be followed up every 3 months to evaluate the survival.

Being tested
Nimotuzumab and Docetaxel
Keywords
Nimotuzumab, NSCLC, Docetaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nimotuzumab and DocetaxelDrug

    Also called Nimotuzumab

    The chemotherapy treatment:Docetaxel was administered every 3 weeks 75 mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD. No more than 4 cycles chemotherapy was given.

    Nimotuzumab treatment: Dose of 200 mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxicity.

Study groups in NCT00983047
Study groupRoleWhat they receive
DocetaxelActive comparatorThe chemotherapy treatment:Docetaxel was administered every 3 weeks 75mg/m2, efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD. No more than 4 cycles chemotherapy was given.
Receives: Drug: Nimotuzumab and Docetaxel
Nimotuzumab and DocetaxelExperimentalThe chemotherapy treatment:Docetaxel was administered every 3 weeks 75mg/m2,efficacy will be evaluated after two cycles,the chemotherapy will be administered continually 2 cycles if the response is CR\PR\SD.No more than 4 cycles chemotherapy was given. Nimotuzumab treatment:Dose of 200mg intravenous infusion per week was continued after the end of chemotherapy until disease progression or unacceptable toxic.
Receives: Drug: Nimotuzumab and Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Survival Time

    Measured: 12 months

Secondary outcomes (5)

  1. Disease control rate

    Measured: 12 months

  2. Time to progression

    Measured: 12 months

  3. Safety of the Nimotuzumab and docetaxel (NCI CTC3.0)

    Measured: 12 months

  4. Quality of life before and after the treatment (QLQ-C30)

    Measured: 12 months

  5. Analysis EGFR expression, EGFR mutation and amplification, K-ras mutation in the tumor tissues

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: The sponsor decide to terminate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00983047
Sponsor's protocol ID
BT-IST-NSCLC-010
Status last verified
Aug 2015
First submitted
21 Sep 2009
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab and Docetaxel in people with Advanced Non-Small Cell Lung Cancer, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The sponsor decide to terminate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Survival Time (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00983047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

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