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New drug combo aims to stop lung cancer recurrence in High-Risk patients

NCT ID NCT07672223

Disease control Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether adding the experimental drug SYS6010 to standard immunotherapy can better prevent lung cancer from returning after surgery. About 570 adults with stage II-IIIB non-small cell lung cancer who did not respond well to pre-surgery treatment will be randomly assigned to receive either the combination or immunotherapy alone. The main goal is to see if the combination extends the time without cancer recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SYS6010 (a drug) combined with an immunotherapy drug (anti-PD-(L)-1 monoclonal antibody)
What this could lead to
If successful, this combination could help prevent lung cancer from coming back after surgery, offering a more effective adjuvant treatment option.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The combination may cause more side effects than standard therapy, and it may not improve disease-free survival.

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

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2031

An estimate. End dates often move.

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 to 75 years

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: 1. Able to understand and willingness to voluntarily provide written informed consent. 2. Age 18 to 75 years, males or females. 3. Histologically confirmed squamous or non-squamous NSCLC. 4. Ability to provide qualified tumor samples. 5. Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory. 6. Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC). 7. The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0). Exclusion Criteria: 1. Participants with a condition requiring further surgical resection, in the investigator's opinion. 2. Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC. 3. Eligible only for incomplete resection. 4. Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC. 5. History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment. 6. Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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