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This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.
This non-interventional, cross-sectional study aims to investigate treatment preferences from a sample of physicians and patients with experience of 1L EGFR-TKI for stage IV NSCLC by administering a survey, which primarily includes a DCE approach.
The study will collect data from participants via the questionnaire developed by the research team. This study will be conducted in two stages. Stage 1 is the study design phase (i.e., qualitative stage and questionnaire development), which includes the development of the questionnaire, identification of key attributes and levels for the Discrete Choice Experiment (DCE), creation of hypothetical patient profiles to explore high-risk factors in physician decision-making beyond the DCE, as well as questionnaire programming, internal review, pilot testing, revisions, and finalization. Stage 2 involves the implementation of the quantitative survey using the finalized questionnaire and the subsequent data analysis to generate insights into treatment preferences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physicians group | Physicians who have experience in the treatment and management of stage IV NSCLC patients with 1L EGFR-TKI. | ||
| Patinet group | Patients receiving or who have received 1L EGFR-TKI treatment for stage IV NSCLC |
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| Measure | Description | Time Frame |
|---|---|---|
| Preferences weights for each attribute level evaluated in the DCE | Preference weights will be estimated for each attribute level included in the DCE where a more positive preference weight indicates a stronger preference for the attribute level. The preference weights allow for comparison for relative preference for levels within the same attribute. | Day of interview/survey completion(Day1) |
| Relative attribute importance (RAI) | The importance measure will be used to evaluate the preferences among treatment attributes. This measure will be calculated by using the difference of utility scores between the most and least preferred levels within an attribute. Then, this measure will divide by the summation of the difference of all tested attributes. | Day of interview/survey completion(Day1) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum acceptable risks (MAR) and minimum acceptable benefit (MAB) | This measure will be used to evaluate the trade-offs participants are willing to make between an improvement in a pre-defined attribute related to efficiency (such as PFS) compared to a worsening in each AE relevant attribute (such as rash).
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Inclusion Criteria:
The following inclusion criteria must be met in order to be enrolled in the stage 1:
Patient:
Physician:
The following inclusion criteria must be met in order to be enrolled in the stage 2:
Patient:
Physician:
Exclusion Criteria:
Not applicable.
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The study population will include patients receiving or who have received 1L EGFR-TKI treatment for stage IV NSCLC and physicians who have experience in the treatment and management of stage IV NSCLC patients with 1L EGFR-TKI. To improve the sample representativeness and generalizability, some soft quotas may be applied during sampling. All the participants who met inclusion criteria will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Chengdu | 610000 | China |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Day of interview/survey completion(Day1) |
| RAI, MAR, and MAB by patient and physician characteristics subgroups |
| Day of interview/survey completion(Day1) |
| Odds ratios (ORs) for the association between patient characteristics and the likelihood of physicians recommending combination therapy (EGFR-TKI plus platinum/pemetrexed chemotherapy or EGFR-TKI plus bispecific antibody) versus EGFR-TKI monotherapy | o OR quantifies changes in the likelihood of physicians recommending combination therapy over monotherapy, depending on the presence or absence of specific patient characteristics (e.g., age, CNS metastases, high tumor burden). An OR > 1 indicates an increased likelihood of recommending combination therapy for patients with the characteristic, while an OR < 1 indicates a decreased likelihood. | Day of interview/survey completion(Day1) |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |