| CTRI Number |
CTRI/2020/11/029081 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival, in participants treated with amivantamab in combination with chemotherapy vs chemotherapy alone in participants with locally advanced or metastatic NSCLC characterized by EGFR Exon 20ins mutations. |
|
Scientific Title of Study
|
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 61186372NSC3001 |
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
|
|
|
Countries of Recruitment
|
Australia
Belgium
Brazil
Canada
China
France
Germany
Hong Kong
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Poland
Portugal
Republic of Korea
Russian Federation
Spain
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| 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 Center |
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 Ullas Batra |
Rajiv Gandhi Cancer Institute & Research Centre |
Room No 2251, Sector 5 Rohini, New Delhi, Delhi, 110085, India
New Delhi
DELHI |
9711080001
ullasbatra@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 Vanita Noronha |
Tata Memorial Hospital |
HBB Bock, Room no 304, 3rd floor, Dr E Borges Road, Department of Medical Oncology, Mumbai, Maharashtra, 400012, India
Mumbai
MAHARASHTRA |
9769328047
vanita.noronha@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| 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 |
| Rajiv Gandhi Cancer Institute & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Amivantamab will be administered as an IV infusion once weekly up to Cycle 2 Day 1 and then 1 on Day 1 of each 21-day cycle starting with Cycle 3 |
| 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 |
| 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 |
99.99 Year(s) |
| Gender |
Both |
| Details |
- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
- Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
- A female participant of childbearing potential must have a negative serum or urine 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 |
|
| ExclusionCriteria |
| Details |
- Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins
- Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
- Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
- Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review |
Up to 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective Response Rate |
Up to 48 months |
| Duration of Response |
Up to 48 months |
| Overall Survival |
Up to 48 months |
| Time to Subsequent Therapy |
Up to 48 months |
| Progression-Free Survival After First Subsequent Therapy |
Up to 48 months |
| Time to Symptomatic Progression |
Up to 48 months |
| Incidence and Severity of Adverse Events |
Up to 48 months |
| Number of Participants with Clinical Laboratory Abnormalities |
Up to 48 months |
| Number of Participants with Vital Signs Abnormalities |
Up to 48 months |
| Number of Participants with Physical Examination Abnormalities |
Up to 48 months |
| Serum Concentration of Amivantamab |
Up to 48 months |
| Number of Participants with Anti-Amivantamab Antibodies |
Up to 48 months |
| European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 |
Up to 48 months |
| Patient Reported Outcomes Measurement Information System-Physical Function |
Up to 48 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="300"
Sample Size from India="20"
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="5"
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 compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations. |