N/A
Completed N=228
Real World Data on Gi(l)Otrif® Dose Adjustment
Source: ClinicalTrials.gov NCT02751879 ↗Enrolled (actual)
228
Serious AEs
7.9%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. — 21.02; 21.13; 44.59; 57.75 Percentage of patients (%)
Summary
This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. |
21.02; 21.13; 44.59; 57.75; 24.84; 16.90 | — |
| PRIMARY Time on Treatment With Gi(l)Otrif® |
18.22; 19.41 | — |
| PRIMARY Time to Progression With Gi(l)Otrif® |
20.03; 25.92 | — |
| SECONDARY Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® |
2.74; 94.52; 2.74 | — |
| SECONDARY Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® |
0.00; 38.03; 0.00; 5.63; 100.00; 15.49 | — |
Eligibility Criteria
Inclusion criteria
- Age = 18 years
- Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
- Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
Exclusion criteria
- Any contraindication to Gi(l)otrif® as specified in label.
- Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
- Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is > or = 6 months.
- Patients treated with Gi(l)otrif® within an interventional trial.
Data sourced from ClinicalTrials.gov (NCT02751879). 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. Informational only — not medical advice.