Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutan… (NCT05534113) | Clinical Trial Compass
UnknownPhase 2
Envafolimab Immunotherapy After ctDNA EGFR Clearance by Treatment With Almonertinib in EGFR-Mutant, PD-LI Positive NSCLC
38 participantsStarted 2022-12-01
Plain-language summary
This is a prospective, single-arm, open-label, interventional clinical study, aimed at exploring the efficacy and safety of sequential Envafolimab immunotherapy after patients with ctDNA EGFR mutation clearance and achieved stable radiographically deep esponse after first line treatment with Almonertinib in EGFR-Mutant, PD-LI positive non-small-cell lung cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Postmenopausal is defined as age greater than 50 years，and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy.
✓. For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels are within the laboratory postmenopausal reference value range, also It can be considered postmenopausal.
✓. Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral fallopian tube ligation.
Exclusion criteria
✕. Previously received antitumor treatment for lung cancer in the past;
✕. Previously received Chinese patent medicine with anti-tumor effect. If Chinese patent medicine with anti-tumor effect has been received for no more than 7 days, and the medicine has been stopped for 2 weeks or more before the drug treatment of this study, it can be included in the group.
✕. The average value of QT interval (QTcF) corrected by Fridericia's formula obtained from 3 ECG examinations at rest\> 470 msec;
✕. Resting ECG suggests that there are various clinically significant rhythms, conduction or ECG morphological abnormalities that are judged by the investigator (such as complete left bundle branch block, 3 degree atrioventricular block, 2 degree atrium Ventricular block and PR interval\> 250 msec, etc.);
✕. There are any factors that increase the risk of QTc prolongation or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death or prolonged QT of immediate family members under 40 Any concomitant drugs in the interval;
What they're measuring
1
PFS
Timeframe: 24 months.
2
TRP
Timeframe: 24 months.
Trial details
NCT IDNCT05534113
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. Liver function: alanine aminotransferase \> 3 times the upper limit of normal (ULN); Aspartate aminotransferase \> 3uln; Total bilirubin \> 1.5uln; Serum albumin (ALB) \< 28 g / L.