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

Bio-Thera Solutions

Status and phase: Enrolling; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: EU-Keytruda®; Drug: BAT3306; Drug: Carboplatin; Drug: US-Keytruda®; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT06280196

BAT-3306-002-CR

Details and patient eligibility

About

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

Full 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.

Enrollment: 676 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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676 participants in 3 patient groups

BAT3306

Experimental group

Description:

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

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: BAT3306

EU-Keytruda® arm

Active Comparator group

Description:

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

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: EU-Keytruda®

US-Keytruda® arm

Active Comparator group

Description:

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

Treatment:

Drug: Pemetrexed

Drug: US-Keytruda®

Drug: Carboplatin