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Researchers test if electronic health records can mimic Gold-Standard cancer studies

NCT ID NCT07485166

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether information from electronic health records can be used to recreate the results of two earlier clinical trials (CheckMate 017 and 057) for advanced lung cancer. Researchers will compare survival outcomes in patients who started either nivolumab or docetaxel, using data from over 800 patients. The goal is not to find a new treatment, but to see if real-world data can reliably answer clinical questions.

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 show that real-world data can reliably replace some traditional trials, speeding up research and lowering costs.
What could go wrong
This is an observational study, not a new treatment test. Results may not match the original trials due to data quality or hidden biases.

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 810 people

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

Started

Mar 2026

Expected to finish

Mar 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

Subjects with NSCLC who present with advanced/metastatic (Stage IIIB/ Stage IV) disease and have experienced disease recurrence or progression during or after the prior platinum doublet-based chemotherapy regimen

Ages

18 years and older

Sex

Anyone

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.

Study Period: ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 2 (EDB2): Follow-up information through February 2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023. Inclusion Criteria: * Age ≥18 years at treatment initiation * Line-of-therapy setting is "advanced" (EDB1), "metastatic" (EDB2), or evidence of metastatic disease at treatment initiation (EDB4) * Subjects with NSCLC who present with advanced/metastatic (Stage IIIB/ Stage IV) disease and received treatment with nivolumab or docetaxel is 2L for advanced/metastatic diseases * ECOG 0 or 1 in the 90 days before/on treatment initiation Exclusion Criteria: * Patients without documentation of disease progression between initiation of 1L platinum doublet-based chemotherapy and initiation of nivolumab or docetaxel * Patients with documentation of docetaxel or nivolumab use before treatment initiation * Patients with documentation of immunotherapy use before treatment initiation * Patients with any prior non-lung malignancy diagnosis (except non-melanoma skin cancers and specified in situ cancers: bladder, gastric, colon, cervical/dysplasia, endometrial, melanoma, or breast) * Patients with documented autoimmune diseases within 2 years before/on treatment initiation * Patients with documented interstitial lung disease before/on treatment initiation * Patients with documented CNS metastases before/on treatment initiation * Patients with any other anti-cancer therapy during the treatment assessment window

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma non-small cell squamous lung carcinoma

As listed by the trial registrant

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

Advanced non-small cell squamous lung cancer Advanced non-squamous non-small-cell lung cancer Advanced squamous non small cell lung cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Somerville, Massachusetts, 02145, United States

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