A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

Bio-Thera Solutions

Status and phase: Enrolling; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: US-Keytruda®; Drug: BAT3306

Study type: Interventional

Funder types: Industry

Identifiers

NCT07180862

BAT-3306-003-CR

Details and patient eligibility

About

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Full description

This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early stage NSCLC. Participants must have no EGFR gene mutation or ALK gene rearrangement, have not received neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy, and have no plans for such treatment. A total of approximately 140 eligible participants will be randomly assigned in a 1:1 ratio to 2 double-blind treatment groups.

Participants who meet all inclusion criteria and none of exclusion criteria will be randomized in an Interactive Web Response System (IWRS).

All participants will receive the investigational medicinal product at 200 mg via intravenous infusion every 3 weeks for a treatment period of up to 12 months . Serum samples will be collected from participants at specified time points for PK analysis to evaluate the PK similarity and PK characteristics of BAT3306 versus Keytruda®, while also assessing their immunogenicity and safety, and preliminarily comparing their improvement in disease-free survival (DFS).

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must meet all of the following criteria:

  1. Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);
  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. Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;

Exclusion criteria

• Participants who meet any of the following criteria will be excluded from the study:

  1. Presence of EGFR gene mutation;

  2. Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;

  3. Have previously received any of the following treatments:

     Have received > 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.

     Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.

     Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.

  4. Prior treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.

  5. Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

BAT3306

Experimental group

Description:

Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).

Treatment:

Drug: BAT3306

US-Keytruda® arm

Active Comparator group

Description:

Once every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).

Treatment:

Drug: US-Keytruda®