Clinical trial NCT04179890: The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib
Official title: UpSwinG: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-squamous, Non-Small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naïve advanced EGFR mutated non-small cell lung cancer (NSCLC),

Brief summary: Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI


Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC),
3. treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice.
4. Informed and privacy consent signature must be obtained depending on local regulations.

   More specific inclusion criteria for each cohort are the following:

   Uncommon mutation cohort:
5. Patients harbouring uncommon or compound EGFR mutations
6. Patients who started with either afatinib (Gi(l)otrif®), gefitinib (Iressa®), erlotinib (Tarceva®), or osimertinib (Tagrisso®) in the first- or second-line setting within regular clinical practice
7. Patients must have started EGFR-TKI treatment at least 12 months prior to data entry.

Sequencing cohort:

5. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. Patients must have started osimertinib treatment at least 10 months prior to data entry.

Patients treated with osimertinib within an early access program/ compassionate use program (EAP/CUP) are allowed

Exclusion Criteria:

1. Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study.
2. Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)
3. For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Further exclusion criteria apply

Primary outcomes:
measure: Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
timeFrame: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.
Secondary outcomes:
measure: Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment
timeFrame: Up to 13 years.
measure: Sequencing Cohort: Overall Response Rate to First Line Afatinib
timeFrame: Up to 6 years.
measure: Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib
timeFrame: Up to 6 years.
measure: Overall Survival
timeFrame: Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.
measure: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start
timeFrame: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for Sequencing Cohort).
measure: Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start
timeFrame: At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for the Sequencing Cohort).
measure: Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2)
timeFrame: From start of first-line treatment to stop of second-line or death by any cause, up to 13 years.
measure: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start
timeFrame: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for "Uncommon EGFR mutation cohort" and between 2014 and 23-Oct-2020 for the "Sequencing Cohort
measure: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation
timeFrame: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).
measure: Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start
timeFrame: Up to 13 years.
measure: Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start
timeFrame: At second-line treatment start (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).
measure: Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation
timeFrame: At second-line treatment stop/end of observation (i.e. between 2007 and 16-Jul-2020 for Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 23-Oct-2020 for the Sequencing Cohort).
measure: Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start
timeFrame: Up to 13 years.
measure: Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
timeFrame: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).
measure: Uncommon Mutation Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line
timeFrame: At start of first-line chemotherapy before index line (i.e. between 2007 and 2019).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
References:
citation: Popat S, Hsia TC, Hung JY, Jung HA, Shih JY, Park CK, Lee SH, Okamoto T, Ahn HK, Lee YC, Sato Y, Lee SS, Mascaux C, Daoud H, Marten A, Miura S. Tyrosine Kinase Inhibitor Activity in Patients with NSCLC Harboring Uncommon EGFR Mutations: A Retrospective International Cohort Study (UpSwinG). Oncologist. 2022 Apr 5;27(4):255-265. doi: 10.1093/oncolo/oyac022.