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Clinical Trials/NL-OMON28617
NL-OMON28617
Recruiting
Not Applicable

Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors

Amsterdam UMC0 sites21 target enrollmentTBD
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Conditionson small cell lung cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on small cell lung cancer
Sponsor
Amsterdam UMC
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

Sponsor
Amsterdam UMC

Eligibility Criteria

Inclusion Criteria

  • •1\. Histologically confirmed NSCLC, positive for EGFR exon 19 deletion or EGFR exon 21 L858R
  • •2\. WHO PS 0\-2
  • •3\. Be willing and able to provide written informed consent for the trial.
  • •4\. Be above 18 years of age on day of signing informed consent.
  • •5\. Patients must have radiological measurable disease
  • •6\. Demonstrate adequate organ function, as deemed acceptable by the treating physician in the context of metastatic NSCLC:
  • •a. Leukocytes \= 3,000/mm3
  • •b. Absolute neutrophil count (ANC) \= 1500/mm3
  • •c. Platelet count \= 100,000/mm3
  • •d. Hemoglobin \= 6 mmol/L

Exclusion Criteria

  • •1\. Inability to provide informed consent
  • •2\. Inability to take study medications
  • •3\. Patients with CNS metastases
  • •4\. 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.
  • •5\. Evidence of interstitial lung disease or active, non\-infectious pneumonitis.
  • •6\. Active infection requiring systemic therapy.
  • •7\. Active Hepatitis B or C.
  • •8\. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • •9\. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit.

Outcomes

Primary Outcomes

Not specified

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