A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study

Guangdong Association of Clinical Trials

ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.

This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.

Study Overview

• Status: Unknown
• Conditions: Overall Survival

Detailed Description

Primary objective

• To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.

Secondary objectives

• To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;
• To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;
• To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.

• Study Type: Observational
• Enrollment (Anticipated): 571

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

It is a non-interventional, retrospective study and all the patients participated in ICAN study will be enrolled.

Description

Inclusion Criteria:

1. Patients ≥18 years old.
2. Provision of informed consent prior to any study specific procedures
3. Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
4. Have completed lung cancer operation
5. The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

1. No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;
2. Patients withdrew consent for ICAN study;
3. Patients in whose medical record was objected to use the existing data for scientific research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	is defined as the time from the date of operation to date of death. For patients who are still alive, the last date when the patient is known to be alive will be used to determine the censoring date.	from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	is defined as the time from operation until recurrence of tumor or death from any cause, whichever occurs first.	•from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.

Collaborators and Investigators

• Sponsor: Guangdong Association of Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CTONG1802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No