An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain

Status: Recruiting
Location: See all (25) locations...
Study Type: Observational
SUMMARY

Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers. Osimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations. The FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors. The results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained. The FLAURA2 trial showed that 1L treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR mutated (EGFRm) advanced NSCLC. The LAURA trial showed that treatment with osimertinib after chemoradiotherapy resulted in significantly longer PFS than placebo among patients with unresectable stage III EGFRm NSCLC. To date, there are no real-world data on osimertinib either in 1L treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials such as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatment in real life in Spain is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression. Therefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC, in 1L treatment in patients with locally advanced or metastatic EGFRm NSCLC, as consolidation treatment in patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy in patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, quality of life, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female or male patients, treated with osimertinib

• Age ≥ 18 years at starts of osimertinib treatment (i.e., index date).

• Patients histologically diagnosed with EGFRm NSCLC (before index date):

‣ Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1).

⁃ Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2).

⁃ Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3).

⁃ Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4).

• Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study.

Locations
Other Locations
Spain
Research Site
RECRUITING
Alicante
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Barcelona
Research Site
NOT_YET_RECRUITING
C Rdoba
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Girona
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Gran Canaria
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Granada
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Ja N
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L Rida
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La Coru A
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León
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NOT_YET_RECRUITING
M Laga
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Madrid
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Murcia
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Ourense
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Palma
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Sabadell
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NOT_YET_RECRUITING
Salamanca
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RECRUITING
Santa Cruz De Tenerife
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Santander
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Santiago De Compostela
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Seville
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Valencia
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Valladolid
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Vigo
Research Site
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Zaragoza
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-07-28
Estimated Completion Date: 2029-06-15
Participants
Target number of participants: 500
Treatments
Cohort 1
Patients diagnosed with locally advanced or metastatic NSCLC with activating EGFR mutations that received first line treatment with osimertinib (FLAURA regimen).
Cohort 2
Patients with stage IB-IIIA NSCLC after complete tumour resection that has activating mutations in the EGFR (deletion of exon 19 or substitution of exon 21 \[L858R\]) that received adjuvant treatment with osimertinib (ADAURA regimen).
Cohort 3
Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first- line treatment (FLAURA2 regimen).
Cohort 4
Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (LAURA regimen).
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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