Clinical trial · Observational
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: Real World Study on TKI Activity in Uncommon Mutations and Sequencing Giotrif®
NCT04179890CI-TRIAL-00066701UpSwinGcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-squamous, Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib (Gi(l)otrif®) | Drug | — | UNRESOLVED |
| Erlotinib (Tarceva®) | Drug | Erlotinib | ALIAS |
| Gefitinib (IRESSA®) | Drug | Gefitinib | ALIAS |
| Osimertinib (Tagrisso®) | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Drug: Afatinib (Gi(l)otrif®)
- Drug: Erlotinib (Tarceva®)
- Drug: Gefitinib (IRESSA®)
- Drug: Osimertinib (Tagrisso®)
- label
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPopat 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. PMID 35274704