Non-small Cell Lung CancerNCT05769764
A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Daiichi Sankyo at 2 sites in United States.
Trial summary
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Archival tissue specimen and immunohistochemistry staining
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2022to 6 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: The EMR database provided by GRN, an oncology-focused, mission-driven hospital consortium comprised of 37 cancer centers, 85 hospitals and more than two million oncology patients across 13 USA states (New York, Massachusetts, Rhode Island, Maryland, Virginia, South Carolina, Florida, Indiana, Kentucky, Missouri, Arkansas, Kansas, Oklahoma), will be used as the data source for this study.
Who may be able to join
- Age ≥18 years in US
- Histologically or cytologically documented advanced or metastatic NSCLC
- At least one sample available and evaluable for HER3 expression
- Additional population-specific inclusion criteria:
- For Cohort 1:
- Tissue sample collected on or after January 1, 2013
Show all 15Show fewer
- For Cohort 2:
- EGFRm NSCLC previously treated with a 3rd generation EGFR TKI
- 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a 3rd generation TKI (defined as Osimertinib, Aumolertinib [formerly Almonertinib])
- For Cohort 3:
- ALK+ NSCLC
- 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a TKI
- For Cohort 4:
- NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion
- 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment
Who cannot join
- Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination)
- Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor
- Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLeod Health
Florence, South Carolina, 29506
Baptist Health South Florida - Miami Cancer Institute
Miami, Florida, 33176
About this study
Official title: HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.
Read the detailed description
The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).
The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:
- Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
- Generate evidence to support future clinical strategies in this area
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Archival tissue specimen and immunohistochemistry staining
- Keywords
- Non-small Cell Lung Cancer, HER3 Expression Prevalence, Archival Tissue Samples, Real-World Data
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archival tissue specimen and immunohistochemistry stainingOther
This is a non-interventional study and no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: NSCLC | Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4. Receives: Other: Archival tissue specimen and immunohistochemistry staining | |
| Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI | Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples. Receives: Other: Archival tissue specimen and immunohistochemistry staining | |
| Cohort 3: ALK+ NSCLC | Participants with ALK+ NSCLC with matched samples. Receives: Other: Archival tissue specimen and immunohistochemistry staining | |
| Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion | Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion. Receives: Other: Archival tissue specimen and immunohistochemistry staining |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
The overall HER3 expression prevalence estimate will be reported.
Measured: 6 months
HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup
HER3 expression prevalence estimate will be reported by subgroup, including age, gender, smoking status, epidermal growth factor receptor (EGFR) status, AGA status, ethnicity, and location of biopsy.
Measured: 6 months
HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation
HER3 expression prevalence estimate before and after treatment will be reported by patient subpopulation (EGFRm NSCLC previously treated with a 3rd generation EGFR TKI, ALK+ NSCLC, NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start19 Dec 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769764
- Sponsor's protocol ID
- U31402-0003-NIS-MA
- Status last verified
- Apr 2023
- First submitted
- 3 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05769764
- Acronym / sponsor ID
- U31402-0003-NIS-MA
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, HER3 Expression Prevalence, Archival Tissue Samples, Real-World Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 15 Mar 2023 (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.
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.
Detailed description
The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).
The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:
- Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
- Generate evidence to support future clinical strategies in this area
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: NSCLC | – | Other: Archival tissue specimen and immunohistochemistry stainingParticipants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4. |
| Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI | – | Other: Archival tissue specimen and immunohistochemistry stainingParticipants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples. |
| Cohort 3: ALK+ NSCLC | – | Other: Archival tissue specimen and immunohistochemistry stainingParticipants with ALK+ NSCLC with matched samples. |
| Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion | – | Other: Archival tissue specimen and immunohistochemistry stainingParticipants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The EMR database provided by GRN, an oncology-focused, mission-driven hospital consortium comprised of 37 cancer centers, 85 hospitals and more than two million oncology patients across 13 USA states (New York, Massachusetts, Rhode Island, Maryland, Virginia, South Carolina, Florida, Indiana, Kentucky, Missouri, Arkansas, Kansas, Oklahoma), will be used as the data source for this study.
Key inclusion criteria (15 listed)
- Age ≥18 years in US
- Histologically or cytologically documented advanced or metastatic NSCLC
- At least one sample available and evaluable for HER3 expression
- Tissue sample collected on or after January 1, 2013
- EGFRm NSCLC previously treated with a 3rd generation EGFR TKI
Key exclusion criteria (3 listed)
- Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination)
- Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor
- Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
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 |
|---|---|---|
| Archival tissue specimen and immunohistochemistry stainingThis is a non-interventional study and no intervention will be administered. | Other | Cohort 1: NSCLC, Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI, Cohort 3: ALK+ NSCLC, Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion |
Primary outcome
HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
Time frame: 6 months
The overall HER3 expression prevalence estimate will be reported.
HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup
Time frame: 6 months
HER3 expression prevalence estimate will be reported by subgroup, including age, gender, smoking status, epidermal growth factor receptor (EGFR) status, AGA status, ethnicity, and location of biopsy.
HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation
Time frame: 6 months
HER3 expression prevalence estimate before and after treatment will be reported by patient subpopulation (EGFRm NSCLC previously treated with a 3rd generation EGFR TKI, ALK+ NSCLC, NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Clinical Leader study director
Daiichi Sankyo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Daiichi Sankyo at 2 sites 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 15 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HER3 Expression Prevalence Estimate for the NSCLC Population, Overall (time frame: 6 months). The study lists 3 primary outcomes in all. 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 10 Apr 2023.