N/A
N=462
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
Non-squamous, Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04179890 ↗Enrolled (actual)
462
Serious AEs
22.8%
Results posted
May 2023
Primary outcome: Primary: Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) — 9.89; 27.7 Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Afatinib (Gi(l)otrif®) (Drug); Erlotinib (Tarceva®) (Drug); Gefitinib (IRESSA®) (Drug); Osimertinib (Tagrisso®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) |
9.89; 27.7 | — |
| SECONDARY Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment |
96 | — |
| SECONDARY Sequencing Cohort: Overall Response Rate to First Line Afatinib |
131 | — |
| SECONDARY Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib |
75 | — |
| SECONDARY Overall Survival |
24.44; 36.50 | — |
| SECONDARY Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start |
212; 160; 32; 19; 3; 6 | — |
| SECONDARY Number of Participants for Each Category of Methodology Used for Mutational Testing at First Line Treatment Start |
4; 4; 155; 122; 39; 15 | — |
| SECONDARY Uncommon Mutation Cohort: Time on Treatment Until Failure of Second-line (TTF2) |
14.46 | — |
| SECONDARY Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Start |
22; 93; 3; 18; 8; 57 | — |
| SECONDARY Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Second Line Treatment Stop/End of Observation |
5; 9; 4; 9; 1; 0 | — |
| SECONDARY Uncommon Cohort: Number of Participants for Each Type of Biological Samples Used for Mutation Detection at Index Therapy Start |
199; 29; 2; 2; 3 | — |
| SECONDARY Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Start |
23; 121; 2; 2; 3; 13 | — |
| SECONDARY Number of Participants for Each Type of Methodology Used for Mutational Testing at Second-line Treatment Stop/End of Observation |
7; 11; 2; 2; 1; 3 | — |
| SECONDARY Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Index Therapy Start |
4; 146; 34; 18; 41 | — |
| SECONDARY Uncommon Mutation Cohort: Number of Participants for Each Type of Methodology Used for Mutation Detection at Start of First-line Chemotherapy Before Index Line |
9; 5; 2; 1 | — |
| SECONDARY 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 |
13; 3; 1 | — |
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
- Adult patients
- Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC),
- treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice.
- 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:
- Patients harbouring uncommon or compound EGFR mutations
- 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
- Patients must have started EGFR-TKI treatment at least 12 months prior to data entry.
Sequencing cohort:
- 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
- Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study.
- Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)
- For uncommon mutation cohort: Patients treated with osimertinib with no further uncommon mutation than acquired T790M Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT04179890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.