New keytruda copycat tested in lung cancer patients after surgery
NCT ID NCT07180862
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This study compares a new drug, BAT3306, to the approved drug Keytruda in people with stage IB-IIIA non-small cell lung cancer whose tumors have been completely removed by surgery. The goal is to see if BAT3306 works similarly as an additional treatment to help keep the cancer from coming back. About 140 adults aged 18 to 75 will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 anti-tumor 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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
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