NCT02549261

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

August 18, 2015

Last Update Submit

September 11, 2015

Conditions

Non-small Cell Lung Cancer

Keywords

nimotuzumabnon-small cell lung cancerradiochemotherapystage IIIA/IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    12months

Secondary Outcomes (5)

  • Overall survival Time

    3 years

  • Quality of life

    12 months

  • Objective response rate

    12months

  • Disease controlled rate

    3 years

  • Adverse event rate

    1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16weeks

Study Arms (3)

the tolerance trial of treatment

EXPERIMENTAL

nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Drug: nimotuzumabDrug: CisplatinDrug: EtoposideRadiation: radiotherapy

A

EXPERIMENTAL

nimotuzumab,chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Drug: nimotuzumabDrug: CisplatinDrug: EtoposideRadiation: radiotherapy

B

PLACEBO COMPARATOR

chemotherapy (Cisplatin+Etoposide),radiotherapy,9 pts

Drug: CisplatinDrug: EtoposideRadiation: radiotherapy

Interventions

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).

Athe tolerance trial of treatment
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.

ABthe tolerance trial of treatment
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.

ABthe tolerance trial of treatment
radiotherapyRADIATION

the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.

ABthe tolerance trial of treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.
  • pregnancy, lactation, fertility but using a prohibited contraceptive method.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nimotuzumabCisplatinEtoposideRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesTherapeutics

Study Officials

  • Lvhua Wang, profressor

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

September 15, 2015

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

December 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

CN(1)