New lung cancer drug shows promise in Head-to-Head trial

NCT ID NCT06280196

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called BAT3306 against the standard treatment Keytruda, both combined with chemotherapy, in 162 people with advanced non-small cell lung cancer. The goal was to see if BAT3306 works as well as Keytruda in shrinking tumors. The trial was stopped early, so results are limited.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

162 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants are eligible to be included in the study only if all the following criteria are met: 1. Male or female, age ≥18 years on the day of signing informed consent. 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. Life expectancy ≥3 months, per the investigator's evaluation. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 5. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC. 6. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement. Exclusion Criteria: * Participant must be excluded from participating in the study if the participant: 1. Is pregnant or a nursing female. 2. 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. 3. 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. 4. Before the first dose of study intervention: * Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy * 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. 5. Is expected to require any other form of antineoplastic therapy while participating in the study. and so on

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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

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

    Wuhan, Hubei, China

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