Will the treatment with afatinib pills and osimertinib pills work longer if chemotherapy is added to them in EGFR mutated lung cancer?

Phase 1

• Conditions: non small cell lung cancer (NSCLC); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003025-37-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-06
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

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

Creatinine = 1.5 x ULN or creatinine clearance (CrCl) =40 mL/min (if using the Cockcroft-Gault formula below):

Female CrCl = [(140 - age) x weight x 0.85]/(0.85 x creat in mmol/L)

Male CrCl = [(140 - age) x weight x 1.00]/(0.81 x creat in mmol/L)

Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome)

AST and ALT = 3 times the upper limit of normal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified