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

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2025-07-30

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BAT3306

25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle

Group Type: EXPERIMENTAL

BAT3306

Intervention Type: DRUG

One vial of 4 mL of concentrate contains 100 mg of BAT3306

Pemetrexed

Intervention Type: DRUG

500 mg/m2 on Day 1 of each 21-day cycle of the study

Carboplatin

Intervention Type: DRUG

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

EU-Keytruda® arm

25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle

Group Type: ACTIVE_COMPARATOR

EU-Keytruda®

Intervention Type: DRUG

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Pemetrexed

Intervention Type: DRUG

500 mg/m2 on Day 1 of each 21-day cycle of the study

Carboplatin

Intervention Type: DRUG

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

US-Keytruda® arm

25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle

Group Type: ACTIVE_COMPARATOR

US-Keytruda®

Intervention Type: DRUG

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Pemetrexed

Intervention Type: DRUG

500 mg/m2 on Day 1 of each 21-day cycle of the study

Carboplatin

Intervention Type: DRUG

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Interventions

BAT3306

One vial of 4 mL of concentrate contains 100 mg of BAT3306

Intervention Type: DRUG

EU-Keytruda®

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Intervention Type: DRUG

US-Keytruda®

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Intervention Type: DRUG

Pemetrexed

500 mg/m2 on Day 1 of each 21-day cycle of the study

Intervention Type: DRUG

Carboplatin

Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles

Intervention Type: DRUG

Other Intervention Names

Pembrolizumab Injection; Pembrolizumab Injection; Pembrolizumab Injection; Pemetrexed Fresenius Kabi; Carboplatin Kabi

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, per the investigator's evaluation.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bio-Thera Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaorong Dong, Dr.

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Union Hospital Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

BAT-3306-002-CR

Identifier Type: -

Identifier Source: org_study_id