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CTRI Number  CTRI/2020/07/026825 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 09/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations 
Scientific Title of Study   Single arm study to evaluate the safety of Dacomitinib for the first-line treatment of participants in India with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR)-activating mutations 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
A7471064 (Original Protocol dated 01 April 2020)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Pai 
Designation  Director (Site Relationship and Excellence Partner) 
Affiliation  Pfizer Products India Private Limited 
Address  Global Site & Study Operations, Clinical Development & Operations, Global Product Development,
Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India 
Phone  8826422322  
Fax    
Email  seema.pai@pfizer.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema Pai 
Designation  Director (Site Relationship and Excellence Partner) 
Affiliation  Pfizer Products India Private Limited 
Address  Global Site & Study Operations, Clinical Development & Operations, Global Product Development,
Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India 
Phone  8826422322  
Fax    
Email  seema.pai@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Inc., 235 East 42nd Street, New York, NY 10017 
 
Primary Sponsor  
Name  Pfizer Inc 
Address  235 East 42nd Street New York NY 10017 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Pfizer Products India Private Limited  The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra(E), Mumbai 400051, INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Arjun Bondarde  Apex Wellness Hospital  Survey No. 799, Plot No. 187, Behind Prakash Petrol pump, Govind Nagar, Nashik – 422009, Maharashtra, India
Nashik
MAHARASHTRA 
9822012427

shaileshbondarde1971@gmail.com 
Dr Vineet Govinda Gupta  Artemis Hospital  Sector 51, Gurugram - 122001, Haryana, India
Gurgaon
HARYANA 
9958418121

vineet.gupta@artemishospitals.com 
Dr Nirmal Vivek Raut  Bhaktivedanta Hospital and Research Institute  Srishti Complex, Bhaktivedanta Swami Marg, Mira Road (East) Thane - 401107, Maharashtra, India
Thane
MAHARASHTRA 
9930398156

drnirmalraut@gmail.com 
Dr Chanchal Goswami  Medica Superspecialty Hospital  127, Mukundapur, E.M. Bypass, Kolkata - 700 099, West Bengal, India
Kolkata
WEST BENGAL 
9830055035

drcgoswami@gmail.com 
Dr Tushar Vishwasrao Patil  Sahyadri Super Speciality Hospital  30-C Erandwane, Karve Road, Pune - 411004, Maharashtra, India
Pune
MAHARASHTRA 
9552522556

tussipats@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Artemis Health Sciences IEC  Approved 
Bhaktivedanta Hospital Ethics committee  Approved 
Clinical Research Ethics Committee, Medica Superspecialty Hospital  Submittted/Under Review 
Ethics Committee of Care Institute of Medical Sciences  Approved 
GCRI/GCS Ethics Committee  Approved 
IEC- Poona Medical and Research Foundation  Approved 
Institutional Ethics Committee - Tata Memorial Centre  Submittted/Under Review 
Institutional Ethics Committee, Yashoda Hospitals  Approved 
Institutional Review Board - Rajiv Gandhi Cancer Institute and Research Centre  Approved 
National Cancer Institute Ethics Committee  Approved 
Sahyadri Hospitals Limited Ethics Committee  Submittted/Under Review 
Shatabdi Hospital Ethics Committee  Approved 
Tata Medical Center - Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dacomitinib (PF-00299804)  45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurs. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  (1)Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test.
(2)No prior treatment with systemic therapy and EGFR/Other TKIs for metastatic NSCLC.
(3)Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible.
(4)Age ≥18 years.
(5)ECOG PS of 0-2.
(6)Adequate. hematologic, renal, liver function.
(7)Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <1 except for AEs that in the investigators judgment do not constitute a safety risk for the participant.
(8)Serum or urine pregnancy test (for females of childbearing potential) negative at Screening. Contraceptive use should be consistent with the approved India local product document for Dacomitinib. 
 
ExclusionCriteria 
Details  (1)Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer
(2)Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation
(3)Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (<10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry. Prior irradiation to >25% of the bone marrow.
(4)Major surgery within 4 weeks prior to first dose of Dacomitinib. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
(5)Known prior or suspected severe hypersensitivity to Dacomitinib or any component of its formulation
(6)History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
(7)Other severe acute or chronic medical or psychiatric condition, that may interfere with the interpretation of study results and, would make the participant inappropriate for entry into this study.
(8)Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of Dacomitinib.
(9)Breastfeeding female participants
(10)Participation in other studies involving investigational drug(s) (Phases 1 - 4) within 2 weeks before the current study begins and/or during study participation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of Adverse Events (AEs)  From the time of first dose to 28 days post last dosing date or the date of initiation of a new anticancer therapy, whichever occurs first. 
 
Secondary Outcome  
Outcome  TimePoints 
Confirmed ORR and DoR as assessed by the investigator using RECIST version 1.1.  From time of first dose (for ORR) or time of first tumor response (for DoR) until disease progression, death or initiation of a new anticancer therapy, whichever occurs first. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   03/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary   Dacomitinib is a kinase inhibitor indicated for the first line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.
This is a Phase 4, open label, single arm, multicenter, prospective clinical trial of Dacomitinib for the first line treatment of newly diagnosed adult participants with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.  The current single country, multi-centric, open label, single arm, prospective clinical trial is a post-approval study to fulfill the Central Drugs Standard Control Organization (CDSCO)  request relating to the use of Dacomitinib in patients with metastatic non small cell lung cancer with EGFR activating mutations. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with Dacomitinib. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with Dacomitinib. 
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