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

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.

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

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: BAT3306; Drug: Pemetrexed; Drug: Carboplatin; Drug: EU-Keytruda®; Drug: US-Keytruda®

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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science & Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT3306; 25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle	Drug: BAT3306; One vial of 4 mL of concentrate contains 100 mg of BAT3306; Other Names: Pembrolizumab Injection; Drug: Pemetrexed; 500 mg/m2 on Day 1 of each 21-day cycle of the study; Other Names: Pemetrexed Fresenius Kabi; Drug: Carboplatin; Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles; Other Names: Carboplatin Kabi
Active Comparator: EU-Keytruda® arm; 25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle	Drug: Pemetrexed; 500 mg/m2 on Day 1 of each 21-day cycle of the study; Other Names: Pemetrexed Fresenius Kabi; Drug: Carboplatin; Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles; Other Names: Carboplatin Kabi; Drug: EU-Keytruda®; One vial of 4 mL of concentrate contains 100 mg of pembrolizumab; Other Names: Pembrolizumab Injection
Active Comparator: US-Keytruda® arm; 25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle	Drug: Pemetrexed; 500 mg/m2 on Day 1 of each 21-day cycle of the study; Other Names: Pemetrexed Fresenius Kabi; Drug: Carboplatin; Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles; Other Names: Carboplatin Kabi; Drug: US-Keytruda®; One vial of 4 mL of concentrate contains 100 mg of pembrolizumab; Other Names: Pembrolizumab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of BAT3306	The Investigator and any qualified designees are responsible for detecting, documenting, and reporting events that meet the definition of an AE or SAE and remain responsible for following up AE that are serious, considered related to the study intervention or the study, or that caused the participant to discontinue the study.	From signed ICF to 90days after the last drug administration

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: Xiaorong Dong, Dr., Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Pemetrexed; Carboplatin; pembrolizumab
• Other Study ID Numbers: BAT-3306-002-CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No