Status:
COMPLETED
Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 acquisi...
Detailed Description
The investigators hypothesized that treating advanced stage EGFR mutation positive NSCLC in first line with afatinib and osimertinib in second line (in T790M positive tumors) will cause an apoptotic c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Inability to provide informed consent
- Inability to take study medications
- Patients with symptomatic or unstable CNS metastases
- 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.
- 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.
- Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit.
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05298176
Start Date
January 4 2022
End Date
April 1 2024
Last Update
March 28 2025
Active Locations (1)
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1
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV