Clinical trial NCT06280196: A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Bio-Thera Solutions
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, randomized
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical equivalence
timeFrame: Week 3,5,7,9,12,15,EOT
Secondary outcomes:
measure: safety of BAT3306
timeFrame: From signed ICF to 90days after the last drug administration
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science & Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Xiaorong Dong, Dr.
role: PRINCIPAL_INVESTIGATOR
References: