Skip to main content
MedPathMedPath Home
Clinical Trials/NL-OMON52389
NL-OMON52389
Recruiting
Phase 2

Combining Afatinib and concurrent chemotherapy, followed by Osimertinib and concurrent chemotherapy, in untreated EGFR positive NSCLC tumors - COMBINATIO

Vrije Universiteit Medisch Centrum0 sites21 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Vrije Universiteit Medisch Centrum
Enrollment
21
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- 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:
  • •\- Leukocytes \>\= 3,000/mm3
  • •\- Absolute neutrophil count (ANC) \>\= 1500/mm3

Exclusion Criteria

  • •\- 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
  • •\- 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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumorson small cell lung cancer
NL-OMON28617Amsterdam UMC21
Active, not recruiting
Phase 1
Will the treatment with afatinib pills and osimertinib pills work longer if chemotherapy is added to them in EGFR mutated lung cancer?non small cell lung cancer (NSCLC)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2020-003025-37-NLVU University Medical Center21
Active, not recruiting
Phase 2
Afatinib With CT and RT for EGFR-Mutant NSCLCLung Cancer
NCT01553942Massachusetts General Hospital19
Completed
Phase 2
Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC TumorsNon-Small Cell Lung Cancer
NCT05298176Amsterdam UMC, location VUmc5
Recruiting
Phase 1
The study's aim is to treat adult patients affected by Ph-like ALL, a Philadelphianegative ALL subtype, with a combination of the tyrosine kinase inhibitor ponatinib and chemotherapy. The main objective of the trial is to improve the percentace ofpatients that achieve a disease remission also at the molecular level.
CTIS2023-510240-20-00Fondazione Gimema Franco Mandelli Onlus32