A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants (NCT07180862) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants
China160 participantsStarted 2025-10-14
Plain-language summary
Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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:
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial comparing BAT3306 to Keytruda — does that mean the main goal is to test whether the drug levels in my body behave similarly to Keytruda, rather than to directly measure whether it shrinks tumors, and how does that affect what I might personally gain from joining?
2Since this trial is primarily measuring pharmacokinetic equivalence, what safety unknowns still exist for BAT3306 compared to Keytruda, which already has a longer track record in non-small-cell lung cancer?
3Would my current treatment options — like standard Keytruda or other approved therapies — be put on hold or ruled out if I enrolled in this study, and is it worth waiting to try a biosimilar candidate at this stage?
4How does the Phase 1 nature of this trial affect how much is already known about BAT3306's side effect profile, and are the risks meaningfully different from what's already established with Keytruda?
5Given that this trial is actively recruiting, how quickly would I need to make a decision, and are there logistical demands like frequent blood draws or clinic visits for the PK measurements that I should factor into my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PK equivalence
Timeframe: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)