UnknownPhase 2

Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

China13 participantsStarted 2021-05-07

Plain-language summary

This is a prospective, multi-center, single-arm clinical trial.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Postmenopausal defined as age more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
✓. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more, following cessation of exogenous hormonal treatments, and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory.
✓. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not by tubal ligation.

Exclusion criteria

✕. Prior treatment with an EGFR TKI.
✕. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
✕. Radiotherapy with a limited field of radiation for palliation within 4 week of the first dose of study drug, with the exception of patients receiving radiation to \> 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
✕. Medications that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug.
✕. Mean resting corrected QT interval (QTc) \> 470 ms obtained from electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
✕. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \> 250 ms).
✕. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
✕. Left ventricular ejection fraction (LVEF) ≤ 40%.

What they're measuring

Progression Free Survival (PFS)

Timeframe: From baseline, then every 6 weeks, until disease progression or discontinuation from study. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Trial details

NCT IDNCT04354961

SponsorFujian Cancer Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Gen Lin

86+0591-62002057 lingen197505@163.com

View on ClinicalTrials.gov More Pulmonary Adenosquamous Carcinoma trials