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Why does lung cancer come back? new study hunts for genetic clues

NCT ID NCT06477055

Knowledge-focused Sponsor: Hunan Province Tumor 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study is for people with early-stage lung cancer whose cancer returned after taking the drug osimertinib. Researchers will analyze tumor or blood samples to find gene changes linked to the recurrence. The goal is to better understand why some cancers come back, which could help develop smarter treatments in the future.

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 study could reveal why some lung cancers return after osimertinib, pointing toward better treatments or prevention strategies for recurrence.
What could go wrong
This is an observational study with only 60 participants, so findings may not apply to all patients. It does not test a new treatment, so no direct benefit to participants.

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

43 people

The number who actually took part.

Started

Dec 2025

Finished

Apr 2026

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, real-world study includes patients with resected stage IB-IIIA NSCLC harboring EGFR-sensitizing mutations (exon 19 deletion or exon 21 L858R) who received adjuvant osimertinib. A total of 60 patients are enrolled and classified into two cohorts based on recurrence timing: Cohort 1 comprises 30 patients with recurrence more than 6 months after completing 3 years of adjuvant osimertinib; Cohort 2 comprises 30 patients with recurrence during adjuvant osimertinib treatment. Genomic profiling data of recurrence, obtained from next-generation sequencing of tissue and/or blood samples, are collected and analyzed. All data are extracted from electronic medical records.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Informed consent signed; 2. Age ≥ 18 years; 3. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer; 4. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection; 5. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy; 6. Recurrence after/on Osimertinib treatment according to RECIST 1.1; 7. NGS gene test report (tumor or blood sample) at the time of recurrence; Exclusion Criteria: 1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed; 2. Received adjuvant therapy other than that specified in the ADAURA study; 3. No NGS test report at recurrence; 4. History of other malignant tumors within 2 years; 5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.

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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

  • Hunan Provincal Tumor Hospital

    Changsha, Hunan, 410013, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

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