CHOICE:Decision Factor of EGFR-TKI in Chinese IV NSCLC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide informed consent

18 years or older

Diagnosed with stage IV NSCLC

Currently receiving or previously received 1L EGFR-TKI treatment

Disqualifiers

None

Trial population

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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

590 Participants
are grouped into 2 trial groups
Group A: Physicians group
Group B: Patinet group

Trial outcomes

Primary outcomes

1

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.

Time frame
Day of interview/survey completion(Day1)
2

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.

Time frame
Day of interview/survey completion(Day1)

Secondary outcomes

1

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). * MAR quantifies the average maximum level of risk factors (e.g., incidence of rash, incidence of diarrhea, etc.) that participants are willing to tolerate in exchange for a specified improvement in clinical outcomes. * MAB represents the minimum level of benefit required to justify an increase in risk. It is derived from the marginal rate of substitution (MRS) between risk and benefit attributes, calculated using the estimated preference weights from the DCE model.

Time frame
Day of interview/survey completion(Day1)
2

RAI, MAR, and MAB by patient and physician characteristics subgroups

* RAI quantifies the relative weight participants place on each attribute (e.g., efficacy vs. side effects) in their decision-making. * MAR and MAB will be estimated separately for subgroups defined by patient (e.g., age, gender, with/without central nervous system \[CNS\] metastasis) and physician (e.g., title, years of experience) characteristics.

Time frame
Day of interview/survey completion(Day1)
3

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.

Time frame
Day of interview/survey completion(Day1)

Other outcomes

Sponsors and contacts

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