| CTRI Number |
CTRI/2010/091/001182 [Registered on: 13/10/2010] |
| Last Modified On: |
03/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Non Squamous Non-Small Cell Lung Cancer treatment with the Inhibitor of Epidermal growth factor receptor |
Scientific Title of Study
Modification(s)
|
A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin
Chemotherapy Plus IMC-11F8 Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Nonsquamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)
Acronym INSPIRE
|
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IMCL CP11-0805 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Nilam Kadam Gawande |
| Designation |
|
| Affiliation |
|
| Address |
PPD Pharmaceutical Development (I) Pvt. Ltd
01-Dynasty B-Wing (Kanakia Spaces)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02242486932 |
| Fax |
02242472999 |
| Email |
Nilam.Gawande@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Denzil Benjamin |
| Designation |
|
| Affiliation |
|
| Address |
PPD Pharmaceutical Development (I) Pvt. Ltd
01-Dynasty B-Wing (Kanakia Spaces)
Mumbai
MAHARASHTRA
400059
India |
| Phone |
08041764551 |
| Fax |
02242472999 |
| Email |
Denzil.Benjamin@ppdi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| ImClone LLC
33 ImClone Drive
Branchburg
NJ 08876
USA
|
|
Primary Sponsor
Modification(s)
|
| Name |
ImClone LLC ImClone |
| Address |
Drive Branchburg
NJ USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| PAREXEL INTERNATIONAL CLINICAL RESARCH PVT LTD |
|
|
Countries of Recruitment
Modification(s)
|
India
Australia
Austria
Belgium
Brazil
Canada
Croatia
France
Germany
Greece
Hungary
Italy
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Chirag Desai |
Haemato-Oncology Clinic, Vedanta |
Near Samved Hospital, Navrangpura,-380009
Ahmadabad
GUJARAT |
079 40042223/4
079 40042225
chiragdesai.oncology@gmail.com |
| Dr. Rakesh Chopra |
Indraprastha Apollo Hospital |
Sarita Vihar Delhi-Mathura Road,-110076
New Delhi
DELHI |
011-269-25825
011-416-77024
rakc1@rediffmail.com |
| Dr. Mehboob Basade |
Jaslok Hospital and Research Centre |
15, Dr. Deshmukh Marg, Pedder Road,-400026
Mumbai
MAHARASHTRA |
09821062692.
022 23523330
basade@gmail.com |
| Dr. Sudha Sinha |
MNJ Institute of Oncology and Regional Cancer Center |
Red Hills,Department of Surgical Oncology-500004
Hyderabad
ANDHRA PRADESH |
09866222681
040 23391962
sudhamd@gmail.com |
| Dr. Shailesh Bondarde |
Shatabdi Superspeciality Hospital |
Mumbai Naka,-422005
Nashik
MAHARASHTRA |
0253 2502105
0253 2502105
shaileshbondarde@gmail.com |
| Dr. Anish Maru |
SK Soni Hospital |
Sector 5, Sikar Road, Vidhyadhar Nagar,-302013
Jaipur
RAJASTHAN |
01412232409 Ext 654
01412233337
anishmaru@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee of The Heart Care Clinic |
Approved |
| Ethics Committee on Clinical Trials Indraprastha Apollo Hospital |
Not Applicable |
| Ethics Committee, Jaslok Hospital and Research Centre |
Not Applicable |
| Institutional Ethics Committee - Shatabdi Superspecialty Hospital |
Approved |
| SEAROC Ethics Committee S.K Soni Hospital SEAROC Cancer Centre |
Not Applicable |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Advanced nonsquamous non small cell lung cancer, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Cisplatin ((0.5mg/ml): |
intravenous infusion 75 mg/m² per cycle for 6 three-week cycles
|
| Intervention |
Necitumumab IMC-11F8 (16mg/ml), intravenous infusion: |
Patients will receive IMC-11F8 (2 x 800 mg per three week cycle) until there is documentation of Progression of Disease, unacceptable toxicity, or withdrawal of consent, or until other withdrawal criteria are met. |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Pemetrexed (500mg): |
intravenous infusion 500mg/m² per cycle for 6 three-week cycles
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
? Histologically- or cytologically-confirmed nonsquamous (adenocarcinoma/large cell or other) NSCLC
? Advanced (Stage IIIB or Stage IV) disease at the time of study entry
? Measurable or nonmeasurable (ie, evaluable) disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0
? Tumor tissue available for analysis of EGFR gene copy number and EGFR mutation status (minimum of eight slides, formalin-fixed, paraffin-embedded tissue).
|
|
| ExclusionCriteria |
| Details |
? Squamous cell NSCLC.
? Prior therapy with monoclonal antibodies, signal transduction inhibitors, or any
therapies targeting the EGFR, VEGF, or VEGFR
? Previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy ≥ 1 year prior to randomization are eligible)
? Major surgery or any investigational therapy in the 4 weeks prior to randomization
? Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
? Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The primary outcome is the overall survival (OS) in patients with nonsquamous Stage IIIb or IV NSCLC treated with IMC-11F8 plus pemetrexed-cisplatin chemotherapy (Arm A) versus pemetrexed-cisplatin chemotherapy alone (Arm B) in the first-line metastatic setting.
|
Nil |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To evaluate progression-free survival (PFS) in each arm. |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="947"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, multicenter, open-label phase 3 study comparing the first-line treatment of pemetrexed-cisplatin chemotherapy combined with IMC11F8 versus pemetrexed-cisplatin chemotherapy alone in 947 patients with advanced, nonsquamous (stage IIIb or IV) non-small cell lung cancer. Patients will be enrolled from 175 study centers in North America, South America, Europe, Australia, South Africa and India. The primary objective is to evaluate overall survival. Secondary objectives include progression free survival, objective response rate, time to treatment failure, safety profile, pharmacokinetics and immunogenicity of IMC-11F8, health status, and efficacy parameters as a function of EGFR gene copy number and mutation status. Tentative enrollment start in India will be in31 AUG 2010 after DCGI approval has been obtained. The tartgeted number of patients in India is 45 patients at 6 sites. |