A study to examine pharmacokinetics, effectiveness, and safety of BAT3306 plus chemotherapy and compare with EU-Keytruda® and US-Keytruda® in participants aged greater than or equal to 18 years with Stage IV non squamous non-small cell lung cancer
Scientific Title of Study
A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 plus Chemotherapy versus Keytruda® plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants with Stage IV Non-squamous Non-small Cell Lung Cancer.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol Number: BAT-3306-002-CR Version 1.0, 19-Dec-2023
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
Jinu Jose
Designation
VP, RDS Sales and Clinical Operations, India
Affiliation
IQVIA RDS (India) Private Limited
Address
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103, India
Bangalore KARNATAKA 560103 India
Phone
9886203019
Fax
Email
jinu.jose@iqvia.com
Details of Contact Person Public Query
Name
Jinu Jose
Designation
VP, RDS Sales and Clinical Operations, India
Affiliation
IQVIA RDS (India) Private Limited
Address
Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka – 560103, India
KARNATAKA 560103 India
Phone
9886203019
Fax
Email
jinu.jose@iqvia.com
Source of Monetary or Material Support
Bio-Thera Solutions, Ltd.
Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China
Primary Sponsor
Name
Bio-Thera Solutions, Ltd.
Address
Legal Registered Address: Floor 5, Building A6, 11 Kai-Yuan Blvd, Huangpu District, Guangzhou, China
near transport nagar,Pratap nagar, Bedwas Udaipur-313001, Rajasthan, India Udaipur RAJASTHAN
9739458803
dr.rohitresearch@gmail.com
Dr Raj Vasantrao Nagarkar
HCG Manavata Cancer Centre
Behind Shivang Auto Mumbai Naka, Nashik-422002, Maharashtra, India Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr Sandip Abhaykumar Shah
Hemato Oncology Clinic Ahmedabad Pvt Ltd
Ground Floor & First Floor, Vedanta Institute of Medical Sciences, Near Samved Hospital, Navrangpura, Ahmedabad 380009, Gujarat, India Ahmadabad GUJARAT
9824041170
sandip60@yahoo.com
Dr Mukesh Shantilal
K R Hospital
K R Hospital attached to Mysore Medical College and Research Institute Mysore KARNATAKA
Khasara No. 25 Outer Hingna Ring Road, Mauza Jamtha, Nagpur 441108, Maharashtra, India Nagpur MAHARASHTRA
18002330033
abpathak21@gmail.com
Dr Jayanti Govindji Patel
Nirmal Hospital Pvt Ltd
Ring Road,
Surat-395002, Gujarat, India
Surat GUJARAT
9825121347
pateldrjayanti@gmail.com
Dr Anoop T M
Regional cancer centre
Medical college campus,
Thiruvananthapuram-695011, Kerala, India Thiruvananthapuram KERALA
9447134973
dranooptm@yahoo.co.in
Dr Ghanashyam Biswas
Sparsh Hospitals & Critical Care Private limited
A/407 Saheed Nagar, Bhubaneswar- 751007, Orissa, India Khordha ORISSA
9937500878
drgbiswas@gmail.com
Dr Rajesh Kumar Singh
State Cancer Institute, Indira Gandhi Institute of Medical Science
Sheikhpura Patna-800014 Bihar, India Patna BIHAR
9939088899
drrajeshrccigimstrial@gmail.com
Dr Vanita Noronha
Tata Memorial hospital
Department of medical oncology,
Homi Bhabha block, Dr. E Borges Road, Parel, Mumbai-400012, Maharashtra, India Mumbai MAHARASHTRA
976932804
vanita.noronha@gmail.com
Details of Ethics Committee
No of Ethics Committees= 16
Name of Committee
Approval Status
Ethics Committee GBH Memorial Cancer Hospital
Submittted/Under Review
Ethics Committee of CIMS
Approved
Human Ethics Committee, Regional cancer centre
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Approved
Institutional Ethics Committee (IEC)- I
Submittted/Under Review
Institutional Ethics Committee Sparsh hospital
Approved
Institutional Ethics Committee, Dr. Ram Manohar lohia Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee, IGIM
Submittted/Under Review
Institutional Ethics CommitteeRashtrasant Tukdoji Regional Cancer Hospital and Research Centre
Approved
Kingsway Hospitals Ethics Committee
Approved
Magna-Care Ethics Committee
Approved
Manavata Clinical Research Institute Ethics Committee
Approved
National cancer Institute Ethics Committee National Cancer Institute
Approved
Nirmal Hospital Pvt Ltd Ethics Committee
Approved
Sangini Hospital Ethics Committee
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
BAT3306, EU-Keytruda®, and US-Keytruda®
BAT3306, EU-Keytruda®, and US-Keytruda®, 100 mg/4.0 ml, Concentrate for solution for infusion
BAT3306, EU-Keytruda®, and US-Keytruda® must be administered as IV infusion over 30 minutes.
No dose modifications are allowed.
Comparator Agent
Pemetrexed
Carboplatin
Pemetrexed 500 mg/20 ml, Concentrate for solution for
infusion must be administered as an IV infusion over 10 minutes.
Carboplatin 150 mg/15 ml, Concentrate for solution for infusion, AUC 5 mg/mL/min will be administered as an IV infusion over 15-60 minutes Q3W for 4 cycles immediately after pemetrexed as per local practice and labels.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Participants are eligible to be included in the study only if all of the following criteria are met:
1. Male or female, age ≥18 years on the day of signing informed consent.
2. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
3. Life expectancy ≥3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
5. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
6. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.
ExclusionCriteria
Details
Participant must be excluded from participating in the study if the participant:
Medical Conditions
1. Is pregnant or a nursing female.
2. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
3. Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
1. To compare the pairwise PK similarities between BAT3306 and EU-Keytruda®, BAT3306 and US-Keytruda®, and between EU-Keytruda® and US-Keytruda® in participants with nsNSCLC
2. To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC
1. PK parameters at Cycle 6, 1st cycle at Cycle 1
2. Confirmed best overall tumor response rate up to Week 24
Secondary Outcome
Outcome
TimePoints
1. To evaluate the PK characteristics of BAT3306, EU-Keytruda®, & US-Keytruda® in participants with nsNSCLC
1. PK parameters at Cycle 1 & Cycle 6
2. To evaluate the immunogenicity of BAT3306 & pooled EU-Keytruda® & US-Keytruda® in participants with nsNSCLC
3. To further evaluate the efficacy of BAT3306 & pooled EU-Keytruda® & US Keytruda® given with chemotherapy
At Week 6, Week 12, Week 18, & Week 24
Target Sample Size
Total Sample Size="676" Sample Size from India="114" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a multi-center, double-blind, randomized Phase I/III study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
Randomization will occur after the presence of at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 is confirmed. All participants will receive investigational medicinal product (IMP) (BAT3306, EU-Keytruda®, or US-Keytruda®), pemetrexed and carboplatin every 3 weeks up to 4 cycles, followed for those with non-progressive disease with maintenance therapy comprising IMP plus pemetrexed until a maximum of 12 months.
Participants still benefitting by the therapy at 12 months will have the option to receive treatment in the long-term extension period.
All participants will receive study treatment until there is an Investigator-assessed disease
progression, lack of clinical benefit, unacceptable adverse events, participant withdrawn from the study based on Investigator’s judgment, withdrawal of consent, lost to follow-up, death, start of a new anti-cancer therapy, study termination by the Sponsor, or for a maximum month of treatment (end of study), whichever occurs first.