Observational Study of Patients With Locally Advanced or Metastatic NSCLC (Non-Small Cell Lung Cancer)

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: * Adult male or female patients (according to age of majority/adulthood as defined by local regulations) who have given written informed consent as per local regulations. * The primary cohort will include patients with EGFR mutation-positive locally advanced or metastatic NSCLC who have progressed while on or after receiving front-line EGFR-TKI therapy (e.g., gefitinib, erlotinib, afatinib, or icotinib). * Additionally, a secondary cohort of patients will include patients newly diagnosed with locally advanced or metastatic NSCLC who are treatment naive or patients who were diagnosed at an earlier stage but have progressed to metastatic NSCLC during the selection period. (In Spain and France the secondary cohort of patient will be limited to patients with EGFR mutation-positive locally advanced or metastatic NSCLC)

Trial locations and contacts

110 sites in 6 countries.

About this study

Official title: Global PANORAMA Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With Locally Advanced or Metastatic NSCLC.

Conditions

Carcinoma, Non-Small-Cell Lung

Being tested

Patient Reported Outcomes

Keywords

EGFR, EGFR mutation, EGFRm, EGFR-TKI, Health care resource utilization, Health-Related Quality of Life, Locally advanced or metastatic lung cancer, NSCLC, Non-Small Cell Lung Cancer, Observational study, Osimertinib, Personalized medicine, PRO, Patient Reported Outcome, Resistance, T790M, Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Bronchial Neoplasms, Lung Neoplasms

Medical subject headings

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Patient Reported OutcomesOther

  HRQoL will be assessed using questionnaire EORTC QLQ-C30 and the questionnaire EORTC QLQ-LC 13.

  These two questionnaires are validated instruments, translated in various languages and are not used as an intervention but rather to track patient quality of life and symptom reduction in real-life settings. Data for these patient reported outcomes will be collected prospectively from the time of enrolment until the end of follow-up. The two questionnaires will be self-administered by the patients in both cohorts at the enrolment visit and subsequently every 3 months (±1 month) at routine standard of care scheduled visits. The questionnaires are expected to take about 15 minutes to complete

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Parameters in the target population associate with molecular testing patters

   • Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the cohorts
   • Changes in testing rates over time (details will be included in the SAP)
   • Molecular testing details including, but not limited to sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test
   • Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation

   Measured: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months

2. Parameters in the target population associate with treatment patterns and associated clinical outcomes

   • Overall survival measured from:
   • the date of initial diagnosis to date of death from any cause to the index date to date of death from any cause (for primary cohort only)
   • the date of first-line treatment until death
   • the date of second-line treatment until death
   • Overall disease progression:
   • from date of treatment initiation until physician-reported progression, initiation of a new cancer-directed line of therapy (proxy for progression), or death
   • For each line of chemotherapy/targeted therapy received:
   • Therapy regimen
   • Therapy duration measured as time from therapy start date to time of therapy end date
   • Number of cycles received
   • Reason for cessation of therapy
   • Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy
   • For each surgery or radiotherapy received:
   • Type
   • Site
   • Date
   • Any palliative/supportive care received

   Measured: Patients will be followed from enrolment in the study until death, loss to follow-up, withdrawal of consent or study end date. The minimum follow-up will be 12 months and the maximum allowed follow-up will be 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted15 Feb 2017
2. Study start1 Mar 2017
3. Primary completion8 Nov 2017
4. Study completion8 Nov 2017

Why it stopped: Cancelled due to changes in the scientific landscape. Decision was made after thorough evaluation of of pros\&cons, ethical as well as regulatory consideration

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
• More trials run by AstraZenecaThe 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.