PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC

ClinicalTrials.gov ID

NCT02777658

Acronym / sponsor ID

PANORAMA / D5160R00005

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Epidermal Growth Factor Receptor (EGFR), non-small cell lung cancer (NSCLC), EGFR T790M, EGFR Mutation-Positive Locally Advanced or Advanced NSCLC

Study type

Observational

Recruitment status

Completed

Enrolment

169 participants (actual)

Lead sponsor

AstraZenecaIndustry (pharma, biotech, devices)

Collaborators

iOMEDICO AG, Freiburg, Germany

Study start

26 May 2016 (actual)

Primary completion

31 May 2020 (actual)

Study completion

31 May 2020 (actual)

First posted

19 May 2016 (estimated)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

36 Months

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

800 patients across both cohorts - 700 patients primary cohort and 100 patients secondary cohort. Patients will be recruited from approximately 100 participating sites in Germany (70 hospitals and 30 outpatient practices).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC

   Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

   Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including 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;

2. To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC

   Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

   Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles;

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
• Redacted CSR SynopsisLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.

Related trials for Carcinoma, Non-Small-Cell Lung

• RecruitingPhase 1/2

  Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

  Solid Tumor, Non-Small Cell Lung Cancer

• RecruitingObservational study

  A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC

  Non Small Cell Lung Cancer

• RecruitingPhase 3

  A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

  Non-Small Cell Lung Cancer (NSCLC)

• Active, not recruitingPhase 2

  Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

  Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer

• Not yet recruitingPhase 1/2

  STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

  NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

73 sites in 1 country: see every site and its status.