Other Clinical Trial - Almonertinib as First-line Treatment in Patients

Clinical Trial Description

This is a multicenter, single arm, phase II study assessing the efficacy and safety of Almonertinib as first-line treatment in patients with EGFR mutation positive locally advanced or metastatic Pulmonary Adenosquamous Carcinoma. ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Adenosquamous
Pulmonary Adenosquamous Carcinoma

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04354961
Study type	Interventional
Source	Fujian Cancer Hospital
Contact	Gen Lin
Phone	86+0591-62002057
Email	lingen197505@163.com
Status	Recruiting
Phase	Phase 2
Start date	May 7, 2021
Completion date	June 30, 2025

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms