Advanced Non-squamous Non-small-cell Lung CancerNCT07485166
Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
An observational study of Advanced Non-squamous Non-small-cell Lung Cancer and Advanced Squamous Non Small Cell Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non Small Cell Lung Cancer
- What is being tested?
- Initiation of nivolumab and Initiation of docetaxel
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2026to 12 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Somerville, Massachusetts, 02145
About this study
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to complement evidence from RCTs. Yet, to have confidence in the accuracy of non-interventional studies of medical products and their outcomes in oncology, investigators need to know what questions can be validly answered, with which non-interventional study designs, and which analysis methods are appropriate, given the data that is available. Building on a process from the RCT DUPLICATE initiative, EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) is the trial emulation discussed in this protocol is part of the expansion project specific to oncology and aims to emulate 12 randomized oncology RCTs using multiple EHR data sources.
The purpose of this protocol is to describe the emulation of the pooled analysis of CheckMate 017 and CheckMate 057. CheckMate 017/057 were two Phase III, double-blind, randomised studies assessing the efficacy and safety of Nivolumab (3 mg/kg IV every 2 weeks) versus Docetaxel (75 mg/m² IV every 3 weeks) in patients with squamous (CheckMate 017) and nonsquamous (CheckMate 057) advanced Non-small Cell Lung Cancer (NSCLC) and disease progression during or after prior platinum-based chemotherapy.
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non Small Cell Lung Cancer
- Being tested
- Initiation of nivolumab, Initiation of docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of nivolumabDrug
Initiation of nivolumab described in electronic health records is used as the exposure.
Initiation of docetaxelDrug
Initiation of docetaxel described in electronic health records is used as the reference.
| Study group | Role | What they receive |
|---|---|---|
| Initiation of nivolumab | Exposure group Receives: Drug: Initiation of nivolumab | |
| Initiation of docetaxel | Reference group Receives: Drug: Initiation of docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival [OS] - Time to all-cause mortality
Hazard ratio (95% CI) for overall survival
Measured: Through the earliest of outcome, censoring, or end of data (April 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start12 Mar 2026
- Primary completion12 Mar 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485166
- Sponsor's protocol ID
- 2022P002556-ENC-CheckMate1757
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulation of the CheckMate 017/057 (NCT01642004 and NCT01673867) Trials Using Specialty Oncology Electronic Health Records Databases
- ClinicalTrials.gov ID
- NCT07485166
- Acronym / sponsor ID
- 2022P002556-ENC-CheckMate1757
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Mar 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are building an empirical evidence base for real-world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
Randomized controlled trials (RCTs) are generally regarded as the gold-standard of evidence for establishing efficacy of medical products. However, real-world data (RWD) are increasingly used to complement evidence from RCTs. Yet, to have confidence in the accuracy of non-interventional studies of medical products and their outcomes in oncology, investigators need to know what questions can be validly answered, with which non-interventional study designs, and which analysis methods are appropriate, given the data that is available. Building on a process from the RCT DUPLICATE initiative, EmulatioN of Comparative Oncology trials with Real-world Evidence (ENCORE) is the trial emulation discussed in this protocol is part of the expansion project specific to oncology and aims to emulate 12 randomized oncology RCTs using multiple EHR data sources.
The purpose of this protocol is to describe the emulation of the pooled analysis of CheckMate 017 and CheckMate 057. CheckMate 017/057 were two Phase III, double-blind, randomised studies assessing the efficacy and safety of Nivolumab (3 mg/kg IV every 2 weeks) versus Docetaxel (75 mg/m² IV every 3 weeks) in patients with squamous (CheckMate 017) and nonsquamous (CheckMate 057) advanced Non-small Cell Lung Cancer (NSCLC) and disease progression during or after prior platinum-based chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initiation of nivolumab | – | Drug: Initiation of nivolumabExposure group |
| Initiation of docetaxel | – | Drug: Initiation of docetaxelReference group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initiation of nivolumabInitiation of nivolumab described in electronic health records is used as the exposure. | Drug | Initiation of nivolumab |
| Initiation of docetaxelInitiation of docetaxel described in electronic health records is used as the reference. | Drug | Initiation of docetaxel |
Primary outcome
Overall survival [OS] - Time to all-cause mortality
Time frame: Through the earliest of outcome, censoring, or end of data (April 2024)
Hazard ratio (95% CI) for overall survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Non-squamous Non-small-cell Lung Cancer and Advanced Squamous Non Small Cell Lung Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival [OS] - Time to all-cause mortality (time frame: Through the earliest of outcome, censoring, or end of data (April 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.