Treatment Pattern and Patient Outcomes Among Stage I-II Unresected NSCLC Patients

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,666

Keywords

• Non-small cell lung cancer
• NSCLC
• Stage I-II unresected NSCLC
• Radiotherapy
• SBRT
• SABR
• CFRT
• Systemic therapy
• Biomarker testing
• Real-world evidence

Carcinoma, Non-Small-Cell Lung

6,666 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,682 are open to participants now.

This study's planned enrollment of 440 is above the median of 165 across 981 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Study population

Groups and cohorts

• Adult patients with stage I-II unresected NSCLC

  The patient population will include adults aged ≥18 years with stage I-II unresected NSCLC.

Primary outcomes

1. Description of real-world treatment patterns in adult patients with stage I-II unresected NSCLC as per HCP practice.

   The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Type of RT administered, Intent of RT, Timing of RT relative to diagnosis, Managing approach following RT and use of systemic therapy, Type of systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption).

   Time frame: 3 months

2. Description of real-world clinical outcomes in adult patients with stage I-II unresected NSCLC as per HCP practice.

   The description will be based on HCP practice according to treated/managed patients, questionnaire will be used to collect information (Disease status after treatment, specifically evaluating proportion of patients remaining disease-free over time and NSCLC-related mortality over time. Timing between treatment and outcomes of interest, specifically evaluating proportion of patients experiencing disease recurrence over time and distribution of first recurrence type (local, regional, and distant) o Time-to-recurrence distribution by recurrence type.

   Time frame: 3 months

Secondary outcomes

1. Description of patient-level treatment patterns in adult patients with stage I-II unresected NSCLC as per patient reported form (PRF) - based on HCPs' recall.

   The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Type of RT received, Intent of RT, Timing of RT relative to diagnosis, Performance of confirmatory biopsy prior to RT initiation, Systemic therapy following RT, Timing of systemic therapy following RT, RT interruption, Reasons for RT interruption)

   Time frame: 3 months

2. Description of patient-level clinical outcomes in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.

   The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Occurrence and type of treatment-related side effects during or after RT, Disease status after treatment, Most recent disease status after treatment completion, Timing between RT and outcomes of interest).

   Time frame: 3 months

3. Description of patient-level demographic of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.

   The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Age class, sex, race).

   Time frame: 3 Months

4. Description of patient-level clinical characteristics of adult patients with stage I-II unresected NSCLC as per Patient Report Forms - based on Health Care Professionals recall.

   The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Stage of NSCLC, TNM staging (excluding the M component), Histology, Eastern Cooperative Oncology Group (ECOG) performance status, Tumor location (central versus peripheral), Reason for non-resection, Specialist responsible for determining unresectability/non operability).

   Time frame: 3 months

5. Description of patient-level molecular testing patterns in adult patients with stage I-II unresected NSCLC as per PRF - based on HCPs' recall.

   The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Performance of EGFR test. Type of EGFR, Performance of PD-L1 test, PD-L1 expression status).

   Time frame: 3 months

6. Description of factors influencing treatment choice in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.

   The description will be based on patient-level information collected through the Patient Report Forms based on HCPs' recall (Factors influencing the decision not to perform surgical resection, Specialist responsible for determining unresectability/non operability, Factors determining high-risk features definition, Factors determining initial RT treatment choice, separately by treatment (SBRT/SABR and CFRT), Performance of confirmatory biopsy prior to RT initiation, separately by treatment. (SBRT/SABR and CFRT), Factors determining the choice of administering/non-administering systemic therapy after RT, Influence of EGFR results on treatment choice, Influence of PD-L1 results on treatment choice).

   Time frame: 3 months

7. Description of molecular testing pattern in adult patients with stage I-II unresected NSCLC according to Health Care Professionals practice based on treated/managed patients.

   The description will be based on patient-level information collected through the PRFs based on HCPs' recall (Frequency of performance of EGFR test, EGFR type frequency, Different barriers to EGFR testing, Frequency of performance of PD-L1 test, PD-L1 status frequency, Different barriers to PD-L1 testing).

   Time frame: 3 months

8. Description of Health Care Professionals perception towards the administration of systemic therapy following RT to adult patients with stage I-II unresected NSCLC.

   The description will be based on information related to Health Care Pprofessionalss perception and practice (Strength of rationale for administering systemic therapy after RT, Barriers to systemic therapy use, Likelihood of prescription of systemic therapy, Category of patients who might benefit the most from systemic therapy according to systemic therapy type).

   Time frame: 3 months

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: 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.

Access criteria: 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.

Data sharing details ↗ · vivli.org