NCT05298176CompletedPhase 2
Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
The aim of the COMBINATION trial is to prospectively study the sequential approach of using afatinib combined with a short course of chemotherapy, followed by osimertinib, upon progression and acquisition of a T790M mutation, also combined with a short course of chemotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 15 Jan 2022
- Start date
- 4 Jan 2022
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Lung cancer
- NCT number
- NCT05298176
- EudraCT number
- 2020-003025-37
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 5
- From 4 Jan 2022 to the primary completion date, 1 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to take study medications
Other illness
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Active Hepatitis B or C.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Lab values
- Prior EGFR TKI or platinum-doublet therapy for advanced stage NSCLC. Prior (neo)adjuvant treatments are allowed when the last administration is one year or more.
Other
- Inability to provide informed consent
- Patients with symptomatic or unstable CNS metastases
- Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit.
Who the study is looking for
- Histologically confirmed NSCLC, positive for non-exon20insertion uncommon EGFR mutations that are eligible for afatinib therapy in first line
- WHO PS 0-2
- Be willing and able to provide written informed consent for the trial.
- Be above 18 years of age on day of signing informed consent.
- Patients must have radiological measurable disease
- Demonstrate adequate organ function, as deemed acceptable by the treating physician in the context of metastatic NSCLC.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC location VUmc Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.