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Clinical Trials/EUCTR2020-003025-37-NL
EUCTR2020-003025-37-NL
Active, not recruiting
Phase 1

COMBINING AFATINIB AND CONCURRENT CHEMOTHERAPY, FOLLOWED BY OSIMERTINIB AND CONCURRENT CHEMOTHERAPY, IN UNTREATED EGFR POSITIVE NSCLC TUMORS - combination

VU University Medical Center0 sites21 target enrollmentOctober 6, 2020
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Conditionsnon small cell lung cancer (NSCLC)Therapeutic area: Diseases [C] - Cancer [C04]
DrugscarboplatinAlimtaGiotrifTagrisso

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
non small cell lung cancer (NSCLC)
Sponsor
VU University Medical Center
Enrollment
21
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 6, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VU University Medical Center

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed NSCLC, positive for EGFR exon 19 deletion or EGFR exon 21 L858R
  • •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
  • •Platelet count \= 100,000/mm3
  • •Hemoglobin \= 6 mmol/L

Exclusion Criteria

  • •Inability to provide informed consent
  • •Inability to take study medications
  • •Patients with 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.

Outcomes

Primary Outcomes

Not specified

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