BAT3306 versus Keytruda as adjuvant therapy for early-stage non-small-cell lung cancer
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
This trial will test whether BAT3306 has similar pharmacokinetics and safety to Keytruda when given after surgery to adults with early-stage non-small-cell lung cancer who do not have EGFR or ALK mutations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bio-Thera Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07180862 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, double-blind, parallel-controlled Phase 1 trial will compare the pharmacokinetics (PK) of BAT3306 versus Keytruda in approximately 140 participants with completely resected early-stage NSCLC. Eligible adults without EGFR mutations or ALK rearrangements and without prior neoadjuvant/adjuvant chemo- or radiotherapy will be randomized 1:1 and receive 200 mg IV every three weeks for up to 12 months. Scheduled serum sampling will be used to analyze PK parameters, immunogenicity, and safety, with an exploratory look at disease-free survival. Randomization is managed via an IWRS and the trial is conducted at the listed Wuhan study site.
Who should consider this trial
Good fit: Adults aged 18–75 with pathologically confirmed NSCLC who had complete surgical resection, no EGFR or ALK alterations, and no prior neoadjuvant or adjuvant chemotherapy or radiotherapy are the intended participants.
Not a fit: Patients with EGFR mutations, ALK rearrangements, small cell or other excluded histologies, prior neoadjuvant therapy, extensive adjuvant chemotherapy, or planned radiotherapy are unlikely to be eligible or benefit from this trial.
Why it matters
Potential benefit: If BAT3306 proves similar to Keytruda, patients could gain access to an alternative PD‑1 antibody with comparable safety and effectiveness that may expand treatment availability.
How similar studies have performed: PD‑1 inhibitors like pembrolizumab have shown adjuvant benefit in NSCLC and other early-phase biosimilar PD‑1 candidates have demonstrated PK similarity, so this approach builds on existing, partially validated work.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Wuhan, Hubei
- Union Hospital Tongji Medical College Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xiaorong Dong, Dr. — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Yu Sun
- Email: yusun@bio-thera.com
- Phone: 86-15040223137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.