Non-small Cell Lung CancerNCT02549261
Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer
A study testing nimotuzumab, Cisplatin and Etoposide in people with Non-small Cell Lung Cancer, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- nimotuzumab, Cisplatin and Etoposide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2015
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 70
- both male and female
- Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC. Disease must be newly diagnosed.
- Subjects would refer to the radical radiation therapy, but never have the previous chemotherapy or thoracic radiation therapy.
- V20<30%, means that the percentage of the volume of lung which received the radiation<20Gy accounts the whole volume of lung is less than 30%.
- 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.
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- without pulmonary atelectasis, malignant pleural effusion malignant hydropericardium.
- with ECOG performance status 0-2,and Life expectancy of more than 3 months.
- without other malignancy history, except curative carcinoma in situ of cervix and skin basal cell carcinoma.
- 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 ≥90g/L.
- Total bilirubin ≤1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP)≤ 2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, serum creatinine ≤ 1.2 times ULN .
- pulmonary function, FEV1≥1L, and >40% normal value.
- willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- both female and male patients must use adequate methods of contraception.
- Signature of the informed consent
Who cannot join
- Previous radiotherapy, chemotherapy or anticancer biotherapy. Participation other clinical trials within 1 month prior to inclusion in the trial.
- with the measureable lesion or lesion could be determined.
- Severe diseases in lung, i.e. emphysema, interstitial pneumonia, bronchial asthma.
- uncontrolled diabetes-random plasma glucose; RPG>11.1mmol/L.（RPG>11.1mmol/L, blood-fasting sugar; BFS; <7.8mmol/L，the patient also be enrolled）.
- With other serious internal diseases or uncontrolled infection.
- refractoriness dysentery or enterospasm, intestinal obstruction.
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- pregnancy, lactation, fertility but using a prohibited contraceptive method.
- cardiovascular diseases history, congestive heart failure>GradeII, New York Heart Association (NYHA) criteria). With the unstable angina, de novo angina ( happened within 3 month prior to inclusion in the trial) or have myocardial in recently six months.
- With drug addition, I.e. ,drug-taking, drug-taking for long time; type B hepatitis and C hepatitis in active stage, or 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
Read the detailed description
There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- nimotuzumab, non-small cell lung cancer, radiochemotherapy, stage IIIA/IIIB non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
the nimotuzumab treatment: 200mg/w weekly, for 16 weeks. A treatment:nimotuzumab for 3 levels (100mg/w, 200mg/w, 400mg/w, weekly, for 16 weeks).
CisplatinDrug
Concurrent Chemotherapy,50mg/m2 (d1,d8),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy: Cisplatin: 50mg/m2 (d1,d8)4 weeks/cycle, for 2 cycles.
EtoposideDrug
Concurrent Chemotherapy, Cisplatin: Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles.
the consolidation chemotherapy:Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles.
radiotherapyRadiation
the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.
| Study group | Role | What they receive |
|---|---|---|
| the tolerance trial of treatment | Experimental | nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts Receives: Drug: nimotuzumab; Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy |
| A | Experimental | nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts Receives: Drug: nimotuzumab; Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy |
| B | Placebo comparator | chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts Receives: Drug: Cisplatin; Drug: Etoposide; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 12months
Secondary outcomes (5)
Overall survival Time
Measured: 3 years
Quality of life
Measured: 12 months
Objective response rate
Measured: 12months
Disease controlled rate
Measured: 3 years
Adverse event rate
Measured: 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lvhua Wang, profressor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549261
- Sponsor's protocol ID
- BT-NI-LC-2
- Status last verified
- Sep 2015
- First submitted
- 18 Aug 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nimotuzumab in Combination With Radiochemotherapy for Patients With Stage IIIA/IIIB Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02549261
- Acronym / sponsor ID
- BT-NI-LC-2
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- nimotuzumab, non-small cell lung cancer, radiochemotherapy, stage IIIA/IIIB non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with chemoradiotherapy in patients with NSCLC .There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
Detailed description
There is a tolerance trial of Nimotuzumab in Combination With Radiochemotherapy treatment before the randomization,double blind,muti-center sites trial of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the tolerance trial of treatment | Experimental | Drug: nimotuzumab, Drug: Cisplatin, Drug: Etoposide, Radiation: radiotherapynimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
| A | Experimental | Drug: nimotuzumab, Drug: Cisplatin, Drug: Etoposide, Radiation: radiotherapynimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
| B | Placebo comparator | Drug: Cisplatin, Drug: Etoposide, Radiation: radiotherapychemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age from 18 to 70
- both male and female
- Subjects with pathologically or cytologically documented stage IIIB or IV NSCLC. Disease must be newly diagnosed.
- Subjects would refer to the radical radiation therapy, but never have the previous chemotherapy or thoracic radiation therapy.
- V20<30%, means that the percentage of the volume of lung which received the radiation<20Gy accounts the whole volume of lung is less than 30%.
Key exclusion criteria (12 listed)
- Previous radiotherapy, chemotherapy or anticancer biotherapy. Participation other clinical trials within 1 month prior to inclusion in the trial.
- with the measureable lesion or lesion could be determined.
- Severe diseases in lung, i.e. emphysema, interstitial pneumonia, bronchial asthma.
- uncontrolled diabetes-random plasma glucose; RPG>11.1mmol/L.（RPG>11.1mmol/L, blood-fasting sugar; BFS; <7.8mmol/L，the patient also be enrolled）.
- With other serious internal diseases or uncontrolled infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nimotuzumabthe nimotuzumab treatment: 200mg/w weekly, for 16 weeks. A treatment:nimotuzumab for 3 levels (100mg/w, 200mg/w, 400mg/w, weekly, for 16 weeks). | Drug | A, the tolerance trial of treatment |
| CisplatinConcurrent Chemotherapy,50mg/m2 (d1,d8),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy: Cisplatin: 50mg/m2 (d1,d8)4 weeks/cycle, for 2 cycles. | Drug | A, B, the tolerance trial of treatment |
| EtoposideConcurrent Chemotherapy, Cisplatin: Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles. the consolidation chemotherapy:Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles. | Drug | A, B, the tolerance trial of treatment |
| radiotherapythe tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks. | Radiation | A, B, the tolerance trial of treatment |
Primary outcome
Progression-free survival
Time frame: 12months
5 secondary outcomes
Overall survival Time
Time frame: 3 years
Quality of life
Time frame: 12 months
Objective response rate
Time frame: 12months
Disease controlled rate
Time frame: 3 years
Adverse event rate
Time frame: 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lvhua Wang, profressor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nimotuzumab, Cisplatin and Etoposide in people with 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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Progression-free survival (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2015.