| CTRI Number |
CTRI/2022/01/039158 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study of Amivantamab and Lazertinib in Combination with
Chemotherapy Compared with Chemotherapy in Patients
with Locally Advanced or Metastatic Non Small Cell Lung Cancer After Osimertinib Failure |
|
Scientific Title of Study
|
A Phase 3 Open-Label Randomized Study of Amivantamab and Lazertinib in
Combination with Platinum Based Chemotherapy Compared with Platinum Based Chemotherapy in Patients with EGFR Mutated Locally Advanced or
Metastatic Non Small Cell Lung Cancer After Osimertinib Failure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 61186372NSC3002 Amendment 1 dated 06 Aug 2021 |
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 Jogeshwari 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 Jogeshwari East
Mumbai
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 Jogeshwari East
Mumbai
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
|
|
|
Countries of Recruitment
|
Argentina
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
Denmark
France
Germany
Hong Kong
India
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
Poland
Portugal
Republic of Korea
Russian Federation
Spain
Sweden
Taiwan
Turkey
United Kingdom |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Govinda Gupta |
Artemis Hospital |
Dept. of Medical
Oncology Consultant
Medical Oncology,
Medical Oncologist
Sector 51, Gurgaon PIN
122001
Gurgaon
HARYANA
Gurgaon
HARYANA |
9911152107
vineet.gupta@artemishospitals.com |
| Dr Nirmal Raut |
Bhaktivedanta Hospital |
Dept. of Medical
Oncology, Srishti
Complex,Bhaktivedanta
Swami Marg, Mira Road
(East),Thane-401107,
Maharashtra.
Mumbai
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
9930398156
drnirmalraut@gmail.com |
| Dr Rajnish Nagarkar |
HCG Manavata Cancer Centre |
Ground Floor, Behind Shivang Auto, Mumbai Naka, Nasik, Maharashtra, 422002, India
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
9823061929
drrajnagarkar@yahoo.co.in |
| Dr Govind Babu |
Healthcare Global Enterprises Limited |
#44-45/2, 2nd Cross,
Rajaram Mohan Roy
Road Extension,
Double Road,
Bangalore- 560027,
Karnataka, India
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9845072940
kgblaugh@gmail.com |
| Dr Sewanti Limaye |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
2nd Floor, Medical
Research Department, Rao Saheb Achutrao,
Patwardhan Marg,Four
Bunglows, Andheri
West, Mumbai 400053
Mumbai
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
9619607339
sewanti@yahoo.com |
| Dr Minish Jain |
Noble Hospital Pvt Ltd |
Department of Clinical
research, Noble Annex
Hospital,153,Magarpatta City Road, Hadapsar, Pune, Maharashtra, 411013, India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute and Research Centre (RGCI & RC) |
Department of Medical
Oncology Rajiv Gandhi
Cancer Institute and
Research Centre (RGCI
& RC) Sector 5 Rohini
Delhi 110085
North West
DELHI
New Delhi
DELHI |
9711080001
ullasbatra@gmail.com |
| Dr Sandip Ganguly |
Tata Medical Center |
Medical Oncology Room No 23 14 MAR(E-W), New Town, Kolkata, West Bengal, 700160, India
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9663667459
sandip.ganguly@tmckolkata.com |
| Dr Vijay Patil |
Tata Memorial Hospital |
HBB Bock, Room no 304, 3rd floor, Dr E Borges Road, Department of Medical Oncology, Mumbai, Maharashtra, 400012, India
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9567105817
vijaypgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Ethics Committee |
Approved |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Bhakti Vendanta Hospital Ethics Committee |
Approved |
| HCG-Central Ethics Committee |
Approved |
| Institutional Review Board (IRB) Rajiv Gandhi Cancer Institute and Research Centre (RGCI & RC) |
Approved |
| Manavta Clinical Research Institute Ethics Committee |
Approved |
| Noble Hospital Ethics Committee |
Approved |
| Tata Medical centre-Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified, |
|
|
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 |
| Comparator Agent |
Carboplatin |
Carboplatin will be administration as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21 day cycle |
| Intervention |
Lazertinib |
Participants will receive
lazertinib tablets orally |
| Comparator Agent |
Pemetrexed |
Pemetrexed will be administration as IV infusion on Day 1 of each 21 day cycle and then as maintenance monotherapy until disease progression in Arms A and B |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participant must have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors RECIST version 1 point 1 that has not been previously irradiated Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer NSCLC, characterized at or after the tine of locally advanced metastatic disease diagnosis by either epidermal growth factor receptor EGFR Exon 19del or Exon 21 L858R mutation A participant with definitively locally treated brain metastases must be clinically stable and asymptomatic, with or without low-dose corticosteroid treatment less than or equal to 10 milligrams mg prednisone or equivalent, for at least 14 days prior to randomization Participant must have Eastern Cooperative Oncology Group ECOG status of 0 or 1 Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE Version 5 point 0 Grade 1 or baseline level except for alopecia any grade, Grade less than or equal to 2 peripheral neuropathy, or Grade less than or equal to two hypothyroidism stable on hormone replacement A woman of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second line setting after prior treatment with first or second generation EGFR tyrosine kinase inhibitor TKI. Participants who received either neoadjuvant and/or adjuvant treatment are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days 4 half lives prior to randomization that is last dose no later than Day 8 |
|
| ExclusionCriteria |
| Details |
Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
Participant has active brain metastases not definitively treated with local therapy
Participant has leptomeningeal disease or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has known small cell transformation
Participant has a medical history of interstitial lung disease ILD including drug induced ILD or radiation pneumonitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Progression-Free Survival (PFS)
According to RECIST v1.1 Guidelines as Assessed by Blinded Independent Central
Review (BICR) |
Upto 17 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective Response as Assessed by BICR |
Up to 17 months |
| Overall Survival (OS) |
Up to 48 months |
| Duration of Response (DoR) |
Up to 17 months |
| Time to Subsequent Therapy (TTST) |
Up to 17 months |
Progression-Free Survival After First Subsequent Therapy (PFS2)
|
Up to 17 months |
| Intracranial PFS |
Up to 17 months |
Number of Participants with Adverse Events AEs
|
Up to 48 months |
| Time to Symptomatic Progression |
Upto 17 months |
Number of Participants with Clinical Laboratory Abnormalities
|
Upto 48 months |
| Serum Concentration of Amivantamab |
Up to 17 months |
| Plasma Concentration of Lazertinib |
Up to 17 months |
| Number of Participants with AntiAmivantamab Antibodies |
Upto 17 months |
| Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire |
Up to 17 months |
European Organization of Research and Treatment of Cancer Quality of Life
Questionnaire Core 30 |
Up to 17 months |
Patient Reported Outcomes
Measurement Information System Physical Function |
Up to 17 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="30"
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)
|
28/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
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
Modification(s)
|
The purpose of this study is to assess the efficacy of lazertinib, amivantamab, carboplatin, and pemetrexed (LACP) compared with carboplatin and pemetrexed (CP), in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. |