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Lung cancer clue: LKB1 gene may predict best therapy

NCT ID NCT07710599

Knowledge-focused Sponsor: Ling Zhiqiang 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study examines whether changes in the LKB1 gene can help predict how well people with non-small cell lung cancer respond to treatments like chemotherapy, targeted therapy, and immunotherapy. Researchers will analyze tumor samples and medical records from about 300 patients to see if LKB1 status, along with other gene changes, is linked to survival and treatment outcomes. The goal is to improve personalized treatment choices for lung cancer patients.

What this could mean

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

What this could lead to
If successful, this could lead to a way to use LKB1 status to choose the best treatment for each person with non-small cell lung cancer.
What could go wrong
This is a retrospective study that looks at past data, so it cannot prove cause and effect. The results may not apply to all patients or treatments.

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.

Participants

300 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This retrospective study enrolls 300 patients with pathologically confirmed non-small cell lung cancer with archived frozen tumor samples. All eligible participants received routine clinical pathological examination, targeted gene panel sequencing covering STK11, KRAS, KEAP1, TP53and PD-L1 IHC testing. We collect real-world clinical data, treatment regimens and long-term follow-up data to analyze the predictive value of STK11 mutation combined with co-mutation profiles on chemotherapy, targeted therapy and immune checkpoint inhibitor efficacy.

Ages

45 to 94 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: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Patients who received first-line systemic therapy, including chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, or combined treatment. Available clinicopathologic data, including TNM stage, treatment information, and follow-up records. Available tumor tissue samples or clinically validated molecular testing results for assessment of STK11/LKB1 status and co-mutation profiles, including KRAS, KEAP1, and TP53. Available PD-L1 immunohistochemistry (IHC) results or sufficient tumor tissue for PD-L1 TPS assessment, when applicable. Exclusion Criteria: Pathological diagnosis of small cell lung cancer or mixed small cell/non-small cell lung cancer tumors. Insufficient tumor tissue or unavailable testing results that prevent assessment of STK11/LKB1 status, co-mutation profiles, or PD-L1 expression. Missing key clinical information, treatment records, or follow-up data required for survival analysis. Patients who did not receive first-line systemic therapy.

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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

Contacts and locations

Locations

  • Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022

    Hangzhou, Zhejiang, 310022, China

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