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 (UpSwinG)

Boehringer Ingelheim

Status: Completed

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Treatments: Drug: Afatinib (Gi(l)otrif®); Drug: Gefitinib (IRESSA®); Drug: Osimertinib (Tagrisso®); Drug: Erlotinib (Tarceva®)

Study type: Observational

Funder types: Industry

Identifiers

NCT04179890

1200-0316

Details and patient eligibility

About

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

Enrollment: 462 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

462 participants in 2 patient groups

Uncommon EGFR mutation cohort

Description:

This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy: * Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®). * Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®). * Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®). * Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib). In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.

Treatment:

Drug: Osimertinib (Tagrisso®)

Drug: Afatinib (Gi(l)otrif®)

Drug: Osimertinib (Tagrisso®)

Drug: Gefitinib (IRESSA®)

Drug: Afatinib (Gi(l)otrif®)

Drug: Erlotinib (Tarceva®)

Sequencing cohort

Description:

This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence: - Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.

Treatment:

Drug: Osimertinib (Tagrisso®)

Drug: Afatinib (Gi(l)otrif®)

Drug: Osimertinib (Tagrisso®)

Drug: Afatinib (Gi(l)otrif®)