A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC

NCT06280196 | Terminated Phase 3 DMC

• 1 other identifier: BAT-3306-002-CR
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• clinical equivalence

  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. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)

  Week 3,5,7,9,12,15,EOT

Secondary Outcomes (1)

• safety of BAT3306

  From signed ICF to 90days after the last drug administration

Study Arms (3)

BAT3306

EXPERIMENTAL

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

Drug: BAT3306; Drug: Pemetrexed; Drug: Carboplatin

EU-Keytruda® arm

ACTIVE COMPARATOR

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

Drug: EU-Keytruda®; Drug: Pemetrexed; Drug: Carboplatin

US-Keytruda® arm

ACTIVE COMPARATOR

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

Drug: US-Keytruda®; Drug: Pemetrexed; Drug: Carboplatin

Interventions

BAT3306 DRUG

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

Also known as: Pembrolizumab Injection

BAT3306

EU-Keytruda® DRUG

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

Also known as: Pembrolizumab Injection

EU-Keytruda® arm

US-Keytruda® DRUG

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

Also known as: Pembrolizumab Injection

US-Keytruda® arm

Pemetrexed DRUG

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

Also known as: Pemetrexed Fresenius Kabi

BAT3306; EU-Keytruda® arm; US-Keytruda® arm

Carboplatin DRUG

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

Also known as: Carboplatin Kabi

BAT3306; EU-Keytruda® arm; US-Keytruda® arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all the following criteria are met:
• Male or female, age ≥18 years on the day of signing informed consent.
• Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
• Life expectancy ≥3 months, per the investigator's evaluation.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
• Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
• Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.

You may not qualify if:

• Participant must be excluded from participating in the study if the participant:
• Is pregnant or a nursing female.
• 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.
• 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.
• 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.
• Is expected to require any other form of antineoplastic therapy while participating in the study. and so on

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Xiaorong Dong, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 28, 2024
• Study Start: July 19, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)