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Carcinoma, Non-Small-Cell LungPhase 1NCT07180862

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

A Phase 1 study testing BAT3306 and US-Keytruda® in people with Carcinoma, Non-Small-Cell Lung, run by Bio-Thera Solutions at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
BAT3306 and US-Keytruda®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
14 Oct 2025to 30 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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.
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  • 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;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Union Hospital Tongji Medical College Huazhong University of Science & Technology

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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

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

Read the detailed description

This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early stage NSCLC. Participants must have no EGFR gene mutation or ALK gene rearrangement, have not received neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy, and have no plans for such treatment. A total of approximately 160 eligible participants will be randomly assigned in a 1:1 ratio to 2 double-blind treatment groups.

Participants who meet all inclusion criteria and none of exclusion criteria will be randomized in an Interactive Web Response System (IWRS).

All participants will receive the investigational medicinal product at 200 mg via intravenous infusion every 3 weeks for a treatment period of up to 12 months . Serum samples will be collected from participants at specified time points for PK analysis to evaluate the PK similarity and PK characteristics of BAT3306 versus Keytruda®, while also assessing their immunogenicity and safety, and preliminarily comparing their improvement in disease-free survival (DFS).

Being tested
BAT3306, US-Keytruda®
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAT3306Drug

    Also called Pembrolizumab Injection

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

  • US-Keytruda®Drug

    Also called Pembrolizumab Injection

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

Study groups in NCT07180862
Study groupRoleWhat they receive
BAT3306ExperimentalOnce every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
Receives: Drug: BAT3306
US-Keytruda® armActive comparatorOnce every 3 weeks for a maximum of 1 year (not exceeding 18 cycles).
Receives: Drug: US-Keytruda®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  1. PK equivalence

    To evaluate the PK characteristics of BAT3306 and US-Keytruda® in participants with completely resected NSCLC：Cthough

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

  2. immunogenicity equivalence

    To evaluate the immunogenicity of BAT3306 and US-Keytruda® in participants with completely resected NSCLC:Anti-drug antibody (ADA) positive rate at Weeks 1, 4, 10, 16, 22，34，52

    Measured: Weeks 1, 4, 10, 16, 22，34，52

  3. Vital signs

    Number of cases with abnormal vital signs results

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

  4. Physical examination

    Number of cases with abnormal Physical examination results

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

  5. Laboratory Examination

    Number of cases with abnormal Laboratory Examination results

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

  6. Adverse event

    Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0

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

  7. DFS（Disease-free survival）

    the duration of the absence of tumor recurrence or metastasis as per the RECIST 1.1 criteria.

    Measured: Through study completion, No more than of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start14 Oct 2025
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind, randomized
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07180862
Sponsor's protocol ID
BAT-3306-003-CR
Status last verified
Jul 2026
First submitted
19 Aug 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT3306 and US-Keytruda® in people with Carcinoma, Non-Small-Cell Lung, run by Bio-Thera Solutions at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK equivalence (time frame: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07180862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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