NCT07180862Active, not recruitingPhase 1
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 14 Oct 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Bio-Thera Solutions
- Diseases
- Lung cancer
- NCT number
- NCT07180862
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 14 Oct 2025 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.