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Trial Title:
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC
NCT ID:
NCT06280196
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Carboplatin
Pembrolizumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
double-blind, randomized
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
BAT3306
Description:
One vial of 4 mL of concentrate contains 100 mg of BAT3306
Arm group label:
BAT3306
Other name:
Pembrolizumab Injection
Intervention type:
Drug
Intervention name:
EU-Keytruda®
Description:
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Arm group label:
EU-Keytruda® arm
Other name:
Pembrolizumab Injection
Intervention type:
Drug
Intervention name:
US-Keytruda®
Description:
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Arm group label:
US-Keytruda® arm
Other name:
Pembrolizumab Injection
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
500 mg/m2 on Day 1 of each 21-day cycle of the study
Arm group label:
BAT3306
Arm group label:
EU-Keytruda® arm
Arm group label:
US-Keytruda® arm
Other name:
Pemetrexed Fresenius Kabi
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
Arm group label:
BAT3306
Arm group label:
EU-Keytruda® arm
Arm group label:
US-Keytruda® arm
Other name:
Carboplatin Kabi
Summary:
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda,
all administered with pemetrexed and carboplatin.
Detailed description:
This is a multi-center, double-blind, randomized study that includes PK and clinical
equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously
untreated participants with Stage IV nsNSCLC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants are eligible to be included in the study only if all 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.
Exclusion Criteria:
- Participant must be excluded from participating in the study if the participant:
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.
4. Before the first dose of study intervention:
- Had received prior systemic antineoplastic chemotherapy and targeted,
biological therapy
- Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an
antibody targeting other immuno-regulatory receptors or mechanisms.
Examples of such antibodies include (but are not limited to) antibodies
against TIGIT, IDO, PD-L1, CTLA-4, and LAG3.
- Has participated in any other BAT3306 study and has been treated with
BAT3306.
- Had major surgery <3 weeks prior to first dose
- Received radiation therapy to the lung that is > 30 Gy within 6 months of
the first dose of study intervention.
- Completed palliative radiotherapy within 14 days of the first dose of
study intervention.
5. Is expected to require any other form of antineoplastic therapy while
participating in the study. and so on
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huizhou Central People's Hospital
Address:
City:
Huizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Bihui
Start date:
July 19, 2024
Completion date:
October 30, 2028
Lead sponsor:
Agency:
Bio-Thera Solutions
Agency class:
Industry
Source:
Bio-Thera Solutions
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280196
