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Gene test may predict who needs more immunotherapy after lung cancer surgery

NCT ID NCT07179445

Knowledge-focused Sponsor: Tianjin Medical University Cancer Institute and Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at 300 lung cancer patients who had immunotherapy before surgery but still had cancer cells left after the operation. Researchers will use advanced gene testing to find hidden genetic changes that might explain why the cancer didn't fully disappear. The goal is to see if these genetic differences can help doctors decide who needs more treatment after surgery.

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 help doctors identify which lung cancer patients might benefit from additional immunotherapy after surgery, leading to more personalized treatment plans.
What could go wrong
This is an observational study that only looks back at past data, so it cannot prove cause and effect. Results may not apply to all patients or lead to immediate changes in care.

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

About 300 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

May 2026

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 multicenter, retrospective cohort study plans to enroll patients with non-small cell lung cancer (NSCLC). Cases meeting the eligibility criteria between January 2022 and December 2024 will first be identified through the hospital pathology information management system. The screening process consists of two stages: Initial Screening: Extraction of data from electronic medical records for patients aged ≥18 years, with pathologically confirmed NSCLC, and who underwent genetic testing prior to surgery. Collection of Neoadjuvant Immunotherapy Information: 1. Received preoperative neoadjuvant immunotherapy, including regimens such as immune monotherapy, immune combination chemotherapy, or immune combination with antiangiogenic agents, with available postoperative pathological assessment results; 2. Exclusion of EGFR and ALK positivity in pre-treatment biopsy samples; 3. Availability of qualifying surgical tissue samples. Estimating a requirement of 300 cases.

Ages

18 to 100 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: * Aged 18 years or older, regardless of sex. * Pathologically confirmed, resectable non-small cell lung cancer (NSCLC); having received neoadjuvant therapy containing immune checkpoint inhibitors prior to surgery; without achieving pathological complete response (non-pCR) upon postoperative pathological assessment. * Molecular characteristics: Pre-treatment biopsy specimens tested negative for EGFR mutations and ALK fusions by DNA-based NGS or PCR methods. * Sample requirements: Availability of 5-10 formalin-fixed, paraffin-embedded (FFPE) sections prepared from surgical tissue specimens, with ≥5% tumor cell content confirmed by H\&E staining. Exclusion Criteria: * Failure to meet any one of the requisite eligibility criteria specified in the inclusion criteria. * History of a concurrent or prior malignancy at other sites. * Failure to complete the planned cycles of neoadjuvant immunotherapy due to treatment-related toxicities. * Any other condition that, in the judgment of the investigator, renders the patient unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

lung adenocarcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

NSCLC

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute and Hospital(Lead Center)

    Tianjin, China

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