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CTRI Number  CTRI/2020/11/029082 [Registered on: 12/11/2020] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer 
Scientific Title of Study   A Phase 3, Randomized study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
73841937NSC3003  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanish Davis 
Designation  R&D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson & Johnson 
Address  Johnson and Johnson Private Limited, Arena Space, Josgehswari East

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  SDavis20@ITS.JNJ.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanish Davis 
Designation  R&D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson & Johnson 
Address  Johnson and Johnson Private Limited, Arena Space, Josgehswari East


MAHARASHTRA
400060
India 
Phone    
Fax    
Email  SDavis20@ITS.JNJ.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanish Davis 
Designation  R&D Director GCO India 
Affiliation  Janssen Pharmaceutical Companies of Johnson & Johnson 
Address  Johnson and Johnson Private Limited, Arena Space, Josgehswari East


MAHARASHTRA
400060
India 
Phone    
Fax    
Email  SDavis20@ITS.JNJ.com  
 
Source of Monetary or Material Support  
Janssen Research & Development, LLC 
 
Primary Sponsor  
Name  Johnson and Johnson Private Limited 
Address  L. B. S. Marg, Mulund (West), Maharashtra (India) – 400080 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
Belarus
Belgium
Brazil
Canada
China
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
Poland
Portugal
Russian Federation
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Republic of Korea  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M V T Krishna Mohan  Basavatarakam Indo American Centre Hospital and Research Institute  Road No 14, Banjara Hills, Hyderabad, Telangana, 500034, India
Hyderabad
TELANGANA 		 9866154503

mvtkm@yahoo.com 
Dr Rajnish Nagarkar   HCG Manavata Cancer Centre  Behind Shivang Auto, Mumbai Naka, Nasik, Maharashtra, 422002, India
Nashik
MAHARASHTRA 		 9823061929

drrajnagarkar@yahoo.co.in 
Dr Minish Jain  Noble Hospital Pvt Ltd  153,Magarpatta City Road, Hadapsar, Pune, Maharashtra, 411013, India
Pune
MAHARASHTRA 		 9823133390

minishjain009@gmail.com 
Dr Somnath Roy  Tata Medical Center  Medical Oncology Room No 23 14 MAR(E-W), New Town, Kolkata, West Bengal, 700160, India
Kolkata
WEST BENGAL 		 9051732283

somnath.roy1@tmckolkata.com 
Dr Kumar Prabhash  Tata Memorial Hospital  HBB Bock, Room no 304, 3rd floor, Dr E Borges Road, Department of Medical Oncology, Mumbai, Maharashtra, 400012, India
Mumbai
MAHARASHTRA 		 9224182898

kprabhash1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee, Basavatarakam Indo American Centre Hospital and Research Institute  Approved 
Institutional Ethics Committee, Noble Hospital Pvt. Ltd  Approved 
Institutional Ethics Committee, Tata Memorial Hospital  Approved 
Institutional Review Board Tata Medical Center  Approved 
Manavata Clinical Research, Institute Ethics Committee Institute Ethics Committee (MCRIEC), HCG Manavata Cancer Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amivantamab  Participants will receive amivantamab 1050mg intravenously for body weight less than 80kg and 1400 mg for body weight greater than or equal to 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles 
Intervention  Lazertinib  Participants will receive lazertinib tablets orally 
Comparator Agent  Osimertinib  Participants will receive osimertinib 80 mg/matching placebo orally once daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.99 Year(s)
Gender  Both 
Details  - Participant must have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy
- Participant must have a tumor that was previously determined to have exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. The biopsy must have been obtained at or after the diagnosis of advanced disease
- Unstained tumor tissue (in a quantity sufficient to allow for central analysis of epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the diagnosis of locally advanced or metastatic NSCLC, must be provided
- Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
- Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy
 
 
ExclusionCriteria 
Details  - Participant has received any prior systemic treatment for locally advanced or metastatic disease (adjuvant or neoadjuvant therapy is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)
- Participant has an active or past medical history of leptomeningeal disease
- Participant has spinal cord compression that has not been definitively treated with surgery or radiation or requires steroid treatment within 2 weeks prior to randomization
- Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
- Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib
- Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Progression-Free Survival according to RECIST v1.1 by Blinded Independent Central Review  Up to approximately 42 months 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival  Up to approximately 60 months 
Objective Response Rate  Up to approximately 42 months 
Duration of Response  Up to approximately 42 months 
Progression-Free Survival After First Subsequent Therapy  Up to approximately 42 months 
Time to Symptomatic Progression  Up to approximately 42 months 
Intracranial PFS  Up to approximately 42 months 
Incidence and Severity of Adverse Events  Up to approximately 60 months 
Number of Participants with Clinical Laboratory Abnormalities  Up to approximately 60 months 
Number of Participants with Vital Signs Abnormalities  Up to approximately 60 months 
Number of Participants with Physical Examination Abnormalities  Up to approximately 60 months 
Serum Concentration of Amivantamab  Up to approximately 42 months 
Plasma Concentration of Lazertinib  Up to approximately 42 months 
Number of Participants with Anti-Amivantamab Antibodies  Up to approximately 42 months 
Change from Baseline in Non-Small Cell Lung Cancer -Symptom Assessment Questionnaire (NCSLC-SAQ)  Baseline Up to approximately 42 months 
Change from Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)  Baseline Up to approximately 42 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="1000"
Sample Size from India="25" 
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 3 
Date of First Enrollment (India)   08/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/11/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="6"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
 
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