A phase II trial in patients with NSCLC with AZD9291 as >= second line treatment

Phase 1

• Conditions: Patients with NSCLC; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001335-12-GR
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-13
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

For inclusion in the study subjects should fulfill the following criteria:
1. Age >18 years
2. Both sexes
3. Histologically or cytologically documented NSCLC
4. Stage IIIB not amenable to radical therapy or stage IV
5. Presence of EGFR activating mutations (exon 19 deletion or L858R in exon 21)
6. First or second line treatment with EGFR TKIs
7. Performance status (ECOG): 0-1
8. Measurable or evaluable disease
9. Adequate organ function tests (Hb=10g/dL, WBC=3.0 x 109/L , neutrophils count=1.5 x 109/L, platelets=100 x 109/L, Creatinine clearance=50 mL/min, Total bilirubin=1.5 X UNL, AST, ALT and ALP=2.5 x UNL)
10. Normal QT interval in ECG
11. CNS metastases are allowed provided that they have been irradiated and the patient is clinically stable
12. Women of child bearing potential and all men will be required to use adequate contraceptive measures
13. Life expectancy of at least 3 months
14. Written informed consent
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 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. History of serious drug allergy
2. Refractory nausea, vomiting and chronic gastrointestinal diseases
3. Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
4. Severe or uncontrolled systemic liver disease, including those with known hepatitis B, hepatitis C, and Human Immunodeficiency virus (HIV) infection
5. Interstitial lung disease or pulmonary fibrosis
6. Pregnancy, lactation or other concomitant serious medical condition
7. Other concurrent active malignancy

Study & Design

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