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

NCT07180862 | Recruiting Phase 1

• 1 other identifier: BAT-3306-003-CR
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• PK equivalence

  To compare the pharmacokinetic (PK) similarity of BAT3306 versus US-Keytruda® as adjuvant therapy in participants with completely resected NSCLC：AUC0-τ, ss

  Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)

Secondary Outcomes (7)

• PK equivalence

  Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days）

• immunogenicity equivalence

  Weeks 2, 4,12,18,24

• Vital signs

  The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)

• Physical examination

  The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)

• Laboratory Examination

  The third and sixth weeks of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)

Study Arms (2)

BAT3306

EXPERIMENTAL

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

Drug: BAT3306

US-Keytruda® arm

ACTIVE COMPARATOR

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

Drug: US-Keytruda®

Interventions

BAT3306 DRUG

One vial of 4 mL of concentrate contains 100 mg of BAT3306

Also known as: Pembrolizumab Injection

BAT3306

US-Keytruda® DRUG

One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Also known as: Pembrolizumab Injection

US-Keytruda® arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaorong Dong, Dr.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Sun

CONTACT

86-15040223137; yusun@bio-thera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 18, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)