Carcinoma, Non-Small-Cell LungPhase 3NCT06280196
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC
A Phase 3 study testing BAT3306, EU-Keytruda® and US-Keytruda® in people with Carcinoma, Non-Small-Cell Lung, run by Bio-Thera Solutions at 1 site in China.
Trial summary
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- BAT3306, EU-Keytruda® and US-Keytruda®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to 30 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all the following criteria are met:
- Male or female, age ≥18 years on the day of signing informed consent.
- Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
- Life expectancy ≥3 months, per the investigator's evaluation.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC.
- Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.
Who cannot join
- Participant must be excluded from participating in the study if the participant:
- Is pregnant or a nursing female.
- Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
- Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.
- Before the first dose of study intervention:
- Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy
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- Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG3.
- Has participated in any other BAT3306 study and has been treated with BAT3306.
- Had major surgery <3 weeks prior to first dose
- Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study intervention.
- Completed palliative radiotherapy within 14 days of the first dose of study intervention.
- Is expected to require any other form of antineoplastic therapy while participating in the study. and so on
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei
About this study
Official title: A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 Plus Chemotherapy Versus Keytruda® Plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants With Stage IV Non-squamous Non-small Cell Lung Cancer.
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
Read the detailed description
This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BAT3306, EU-Keytruda®, US-Keytruda®, Pemetrexed, Carboplatin
- 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
EU-Keytruda®Drug
Also called Pembrolizumab Injection
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
US-Keytruda®Drug
Also called Pembrolizumab Injection
One vial of 4 mL of concentrate contains 100 mg of pembrolizumab
PemetrexedDrug
Also called Pemetrexed Fresenius Kabi
500 mg/m2 on Day 1 of each 21-day cycle of the study
CarboplatinDrug
Also called Carboplatin Kabi
Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| BAT3306 | Experimental | 25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle Receives: Drug: BAT3306; Drug: Pemetrexed; Drug: Carboplatin |
| EU-Keytruda® arm | Active comparator | 25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle Receives: Drug: EU-Keytruda®; Drug: Pemetrexed; Drug: Carboplatin |
| US-Keytruda® arm | Active comparator | 25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle Receives: Drug: US-Keytruda®; Drug: Pemetrexed; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical equivalence
To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)
Measured: Week 3,5,7,9,12,15,EOT
Secondary outcomes (1)
safety of BAT3306
The Investigator and any qualified designees are responsible for detecting, documenting, and reporting events that meet the definition of an AE or SAE and remain responsible for following up AE that are serious, considered related to the study intervention or the study, or that caused the participant to discontinue the study.
Measured: From signed ICF to 90days after the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Jul 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Why it stopped: The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaorong Dong, Dr., Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280196
- Sponsor's protocol ID
- BAT-3306-002-CR
- Status last verified
- Dec 2025
- First submitted
- 4 Feb 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/III, Multi-center, Randomized, Double-blind Study of BAT3306 Plus Chemotherapy Versus Keytruda® Plus Chemotherapy to Evaluate Pharmacokinetics, Efficacy, and Safety in Participants With Stage IV Non-squamous Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT06280196
- Acronym / sponsor ID
- BAT-3306-002-CR
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin.
Detailed description
This is a multi-center, double-blind, randomized study that includes PK and clinical equivalence comparisons, aimed at comparing BAT3306 with Keytruda® in previously untreated participants with Stage IV nsNSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- double-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| BAT3306 | Experimental | Drug: BAT3306, Drug: Pemetrexed, Drug: Carboplatin25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle |
| EU-Keytruda® arm | Active comparator | Drug: EU-Keytruda®, Drug: Pemetrexed, Drug: Carboplatin25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 21-day cycle |
| US-Keytruda® arm | Active comparator | Drug: US-Keytruda®, Drug: Pemetrexed, Drug: Carboplatin25 mg/mL concentrate for solution for infusion. 200 mg on Day 1 of each 21-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants are eligible to be included in the study only if all the following criteria are met:
Key exclusion criteria (12 listed)
- Participant must be excluded from participating in the study if the participant:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT3306Also: Pembrolizumab InjectionOne vial of 4 mL of concentrate contains 100 mg of BAT3306 | Drug | BAT3306 |
| EU-Keytruda®Also: Pembrolizumab InjectionOne vial of 4 mL of concentrate contains 100 mg of pembrolizumab | Drug | EU-Keytruda® arm |
| US-Keytruda®Also: Pembrolizumab InjectionOne vial of 4 mL of concentrate contains 100 mg of pembrolizumab | Drug | US-Keytruda® arm |
| PemetrexedAlso: Pemetrexed Fresenius Kabi500 mg/m2 on Day 1 of each 21-day cycle of the study | Drug | BAT3306, EU-Keytruda® arm, US-Keytruda® arm |
| CarboplatinAlso: Carboplatin KabiTarget AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles | Drug | BAT3306, EU-Keytruda® arm, US-Keytruda® arm |
Primary outcome
clinical equivalence
Time frame: Week 3,5,7,9,12,15,EOT
To compare the efficacy of BAT3306 and pooled EU-Keytruda® and US-Keytruda® given with chemotherapy as first line treatment using ORR assessed by BIRC to show clinical equivalence in participants with nsNSCLC. Confirmed best overall tumor response rate as assessed by BIRC according to RECIST Version 1.1 (tumor assessments after initiation of a new anti-cancer treatment are excluded)
1 secondary outcome
safety of BAT3306
Time frame: From signed ICF to 90days after the last drug administration
Results and safety
The study was stopped early (reason given: The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaorong Dong, Dr. principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BAT3306, EU-Keytruda® 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The new regulatory developments have led us to conclude that a Phase 3 study is no longer necessary for the development and approval of BAT3306. As such, to ensure effective use of clinical resources, we are terminating this study.). Results are not available in the source record.
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?
clinical equivalence (time frame: Week 3,5,7,9,12,15,EOT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.