Advanced/Metastatic NSCLCNCT06686602
A Study Assessing Risk Factors for Oral Mucositis/Stomatitis and Ocular Surface Events in NSCLC and Breast Cancer
An observational study of Advanced/Metastatic NSCLC and Advanced/Metastatic HER2-negative Breast Cancer, run by Daiichi Sankyo at 1 site in United States.
Trial summary
This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced/Metastatic NSCLC, Advanced/Metastatic HER2-negative Breast Cancer
- What is being tested?
- No drug
- Type of treatment
- Injection or infusion
- How many people
- 13,759 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 18 Mar 2025
- 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: This nested case-control study is conducted in cohorts of adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC, or IV) NSCLC and advanced or metastatic HER2-negative breast cancer. The time period is 2015 to 2023 for the NSCLC cohort and 2012 to 2023 for the breast cancer cohort. This time period was selected to account for the post-immunotherapy era for NSCLC and post-everolimus era for breast cancer.
Who may be able to join
- The inclusion criteria for the NSCLC cohort consists of patients with advanced or metastatic (stage IIIB/IIIC or IV) NSCLC diagnosis between January 1, 2015 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (LOT) for advanced/metastatic disease.
- The inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage IIIB/IIIC and IV) HER2-negative BC diagnosis between January 1, 2012 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one LOT for advanced/metastatic disease.
Who cannot join
- 1) The exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Risk Factors Associated With the Onset of Oral Mucositis/Stomatitis and Ocular Surface Events (OSE) in Patients With Non-small Cell Lung Cancer (NSCLC) and HER2-negative Breast Cancer (BC)
This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Read the detailed description
It is important to identify risk factors for the onset of oral mucositis/stomatitis and OSE to identify high-risk patients who will be taking Dato-DXd. Understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. This objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and OSE. No study drug will be provided or administered for this study.
- Being tested
- No drug
- Keywords
- Advanced/metastatic non-small cell lung cancer (NSCLC), Advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, Oral mucositis/stomatitis, Ocular surface events
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is a non-interventional study and no study drug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC | Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC). Receives: Other: No drug | |
| HER2-negative Breast Cancer | Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE
Measured: From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)
Clinical Characteristics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE
Measured: From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start9 Jul 2024
- Primary completion16 Dec 2024
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/Metastatic NSCLCStudies 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
- 13,759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686602
- Sponsor's protocol ID
- DS1062-0008-NIS-EPI
- Status last verified
- Mar 2025
- First submitted
- 11 Nov 2024
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Risk Factors Associated With the Onset of Oral Mucositis/Stomatitis and Ocular Surface Events (OSE) in Patients With Non-small Cell Lung Cancer (NSCLC) and HER2-negative Breast Cancer (BC)
- ClinicalTrials.gov ID
- NCT06686602
- Acronym / sponsor ID
- DS1062-0008-NIS-EPI
- Keywords
- Advanced/metastatic non-small cell lung cancer (NSCLC), Advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, Oral mucositis/stomatitis, Ocular surface events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,759 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 13 Nov 2024 (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.
This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Detailed description
It is important to identify risk factors for the onset of oral mucositis/stomatitis and OSE to identify high-risk patients who will be taking Dato-DXd. Understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. This objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and OSE. No study drug will be provided or administered for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC | – | Other: No drugAdult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC). |
| HER2-negative Breast Cancer | – | Other: No drugAdult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) human epidermal growth factor receptor 2 (HER2)-negative breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This nested case-control study is conducted in cohorts of adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC, or IV) NSCLC and advanced or metastatic HER2-negative breast cancer. The time period is 2015 to 2023 for the NSCLC cohort and 2012 to 2023 for the breast cancer cohort. This time period was selected to account for the post-immunotherapy era for NSCLC and post-everolimus era for breast cancer.
Key inclusion criteria (2 listed)
- The inclusion criteria for the NSCLC cohort consists of patients with advanced or metastatic (stage IIIB/IIIC or IV) NSCLC diagnosis between January 1, 2015 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (LOT) for advanced/metastatic disease.
- The inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage IIIB/IIIC and IV) HER2-negative BC diagnosis between January 1, 2012 and December 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one LOT for advanced/metastatic disease.
Key exclusion criteria (1 listed)
- 1) The exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.
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 |
|---|---|---|
| No drugThis is a non-interventional study and no study drug will be administered. | Other | HER2-negative Breast Cancer, NSCLC |
Primary outcome
Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE
Time frame: From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)
Clinical Characteristics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE
Time frame: From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)
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 19 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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/Metastatic NSCLC and Advanced/Metastatic HER2-negative Breast Cancer, run by Daiichi Sankyo 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 2 inclusion and 1 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 19 Mar 2025. 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?
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?
Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE (time frame: From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)). The study lists 2 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 19 Mar 2025.