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Report for Clinical Trial NCT03053297

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

This is an observational cohort study of patients with locally advanced or metastatic NSCLC (non-small cell lung cancer). Patients will be recruited from participating sites in Europe, Asia, and Canada. The study will include 2 patient cohorts.

NCT03053297 Carcinoma, Non-Small-Cell Lung
MeSH: Carcinoma Carcinoma, Non-Small-Cell Lung
HPO: Carcinoma Non-small cell lung carcinoma

1 Interventions

Name: Patient Reported Outcomes

Description: 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

Type: Other

Patients newly diagnosed NSCLC Patients with EGFR mutation (+) NSCLC


Primary Outcomes

Description: 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

Measure: Parameters in the target population associate with molecular testing patters

Time: 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

Description: 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: o 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

Measure: Parameters in the target population associate with treatment patterns and associated clinical outcomes

Time: 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

Secondary Outcomes

Description: For each health care setting: Number and % of patients with visits Total number of visits Total length of inpatient hospital and ICU stay

Measure: Estimation of parameters in the target population associate with cancer-related health care utilization patters including inpatient, emergency room, outpatient visits, lenght of inpatient stay

Time: 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

Description: For each treatment complication: o Rate of occurrence defined as the number of patients reporting at least one treatment-related complications divided by the number of evaluable patients2 Treatment-related complications can include, but are not limited to nausea and vomiting, diarrhoea, constipation, skin rash, infections, mouth sores, neutropenia, hyponatremia For each biopsy-related complication: Rate of occurrence defined as the number of patients reporting at least one occurrence of the complication divided by the number of patients receiving a biopsy Biopsy-related complications can include but are not limited to collapsed lung, severe bleeding, bronchial spasms, irregular heart rhythms, death, severe chest pain, light-headedness, trouble breathing, excessive bleeding through the bandage, haemoptysis, fever, infection

Measure: Estimation of parameters in the target population associated with treatment- and biopsy-related complications

Time: 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

Description: Overall CNS metastases rate, defined as the number of patients developing CNS metastases divided by the number of evaluable patients Brain metastases rate, defined as the number of patients developing brain metastases divided by the number of evaluable patients Leptomeningeal metastases rate, defined as the number of patients developing leptomeningeal metastases divided by the number of evaluable patients Treatments for CNS metastases, including type of treatment and dates of treatment

Measure: Estimation of the rate of CNS metastases in the target population including brain metastases and leptomeningeal metastases and treatments associated with CNS metastases

Time: 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

Description: • Change in score from baseline for each Quality of Life (QoL) domain and for overall QoL, measured at each subsequent site visit

Measure: Assessment of patient (HRQoL) using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and EORTC QLQ - Lung Cancer 13 items (EORTC QLQ-LC13)3

Time: 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

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 T790M

Frequencies and percentages will be used to document categorical measures of interest (e.g., number and proportion of patients with a post progression molecular test, number and proportion of patients with a T790M mutation) and will include 95% CIs for key outcome variables. --- T790M ---



HPO Nodes


HPO:
Carcinoma
Genes 16
POLE MSH2 DKC1 SMARCA4 NLRP1 POLD1 CDKN1B MLH1 RSPO1 FGFR3 BCL10 APC STK11 PTEN APC KIT
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1