A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BAT3306, US-Keytruda®.
- Who it may be relevant to
- Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection
Overview
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Detailed 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 160 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).
Interventions
- Drug BAT3306
One vial of 4 mL of concentrate contains 100 mg of BAT3306 - Drug US-Keytruda®
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
Primary outcome measures
- PK equivalence [Time frame: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)]
Secondary outcome measures (7)
- PK equivalence [Time frame: Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days）]
- immunogenicity equivalence [Time frame: Weeks 1, 4, 10, 16, 22，34，52]
- Vital signs [Time frame: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
- Physical examination [Time frame: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
- Laboratory Examination [Time frame: The third and sixth weeks of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
- Adverse event [Time frame: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
- DFS（Disease-free survival） [Time frame: Through study completion, No more than of 1 year]
Eligibility criteria
Inclusion criteria
- Participants must meet all of the following criteria:
- Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);
- Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;
- 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:
- Presence of EGFR gene mutation;
- Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
- 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.
- Prior anti-tumor treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.
- Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital Tongji Medical College Huazhong University of Science & Technology — Wuhan
Identifiers
NCT: NCT07180862 · BAT-3306-003-CR