Clinical trial NCT04207775: Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy
Official title: Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in EGFR Mutation-Positive, Locally Advanced or Metastatic Chinese NSCLC Patients, Who Have Progressed From First-line EGFR-TKI Therapy (PISCES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic NSCLC
Keywords: NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male or female patients (with age ≥18 years old) who have given provision of signed and dated written informed consent by the patient or legally acceptable Patients with confirmed EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed from first line EGFR-TKI therapy

Brief summary: To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.

Detailed description: The objectives of this study are to assess molecular testing, treatment patterns, and associated clinical outcomes among patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed from first-line EGFR-TKI (tyrosine kinase inhibitor) therapy. This study is descriptive in nature and does not attempt to test any specific a priori hypotheses

Eligibility criteria: Inclusion Criteria

1. Male or female patients with age ≥18 years old
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients
3. Patients with prior confirmed EGFR mutation-positive, who have progressed from first line EGFR-TKI\*
4. Provision of written informed consent by the patient should be within 6 weeks of the date of progression from first line EGFR-TKI treatment \*Note：

   1. First-line EGFR-TKI is monotherapy;
   2. EGFR-TKI has been launched in China includes first-generation, second-generation or third-generation EGFR-TKI, but not including the original chemical compound
   3. Exclude the Chinese traditional medicine that is being used to treat lung cancer
   4. Progression was determined according to Recist1.1 criteria.

Exclusion Criteria

1. Involvement in the planning and/or conduct of the other intervention study
2. Previous enrolment in the present study
3. Pregnancy or breast-feeding

Primary outcomes:
measure: Physician-reported clinical outcomes, PFS
timeFrame: From enrolment to follow-up of up to 36 months
measure: Physician-reported clinical outcomes, OS
timeFrame: From enrolment to follow-up of up to 36 months
measure: Time to initiate second line therapy from progression from 1L treatment
timeFrame: From enrolment to follow-up of up to 36 months
measure: Response rate
timeFrame: From enrolment to follow-up of up to 36 months
measure: chemotherapy
timeFrame: From enrolment to follow-up of up to 36 months
measure: immunotherapy
timeFrame: From enrolment to follow-up of up to 36 months
measure: targeted therapy
timeFrame: From enrolment to follow-up of up to 36 months
measure: local therapy
timeFrame: From enrolment to follow-up of up to 36 months
measure: palliative/supportive care
timeFrame: From enrolment to follow-up of up to 36 months
Secondary outcomes:
measure: Molecular testing sample type
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular test outcome
timeFrame: From enrolment to follow-up of up to 36 months
measure: changes in testing rate over time
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular testing rate
timeFrame: From enrolment to follow-up of up to 36 months
measure: Time from progression date to molecular testing
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular testing method of biopsy
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular testing turnaround time
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular test type
timeFrame: From enrolment to follow-up of up to 36 months
measure: reason for molecular testing
timeFrame: From enrolment to follow-up of up to 36 months
measure: Molecular testing laboratory type
timeFrame: From enrolment to follow-up of up to 36 months
measure: reason for not performing a molecular test
timeFrame: From enrolment to follow-up of up to 36 months
measure: mutation status
timeFrame: From enrolment to follow-up of up to 36 months
measure: mutation type
timeFrame: From enrolment to follow-up of up to 36 months
measure: histologic/phenotypic transformation
timeFrame: From enrolment to follow-up of up to 36 months
measure: Overall CNS metastases rate
timeFrame: From enrolment to follow-up of up to 36 months
measure: Brain metastases rate
timeFrame: From enrolment to follow-up of up to 36 months
measure: Leptomeningeal metastases rate
timeFrame: From enrolment to follow-up of up to 36 months
measure: Type of treatments for CNS metastases
timeFrame: From enrolment to follow-up of up to 36 months
measure: Date of treatments for CNS metastases
timeFrame: From enrolment to follow-up of up to 36 months
measure: Change in score from baseline for each QoL domain measured at each subsequent site visit
timeFrame: From enrolment to follow-up of up to 36 months
measure: Change in score from baseline for overall QoL measured at each subsequent site visit
timeFrame: From enrolment to follow-up of up to 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taizhou
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Zhuji
country: China
facility: Research Site
Study officials:
affiliation: West China Hospital
name: Weimin Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: