The START Study Observes Afatinib as First-line Treatment and Sequential Therapy in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Nonsmall Cell Lung Cancer

Non-squamous, Non-Small Cell Lung Cancer Clinical Trial

Official title:

START: Real-world Study on Sequential Therapy With Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206787
• Other study ID #: 1200-0318
• Status: Completed
• Start date: May 20, 2020
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 22, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive

• Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC

• Male and female patients with age =18 years

• Written informed consent per local regulatory requirement

Exclusion Criteria:

• Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted)

• Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment

• Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous, Non-Small Cell Lung Cancer

Intervention

Drug:
• Afatinib
drug

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	West China Hospital	Chengdu
China	First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Afiliated Hospital, Sun Yet-sen University	Guangzhou
China	Hainan Cancer Hospital	Haikou
China	The First Affiliated Hospital, Zhejiang University	Hangzhou
China	China Shenyang Chest Hospital	Shenyang
China	Shenzhen People's Hospital	Shenzhen
China	The First Affiliated Hospital of Zhengzhou Unviersity	Zhengzhou
China	Zhongshan People's Hospital	Zhongshan

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on treatment (TOT) of afatinib as firstline treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC		28 months
Secondary	Time on treatment (TOT) with afatinib as first-line treatment followed by investigator's choice treatment in event of the T790M negative status in real-world setting		28 months
Secondary	Overall Survival from the start of afatinib until the date of death		50 months
Secondary	Progression-Free Survival as judged by an investigator with afatinib in first-line treatment		33 months
Secondary	Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1		33 months
Secondary	Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1		33 months
Secondary	Proportion of resistance mechanisms after afatinib first-line		12 months
Secondary	Adverse Event(s), Serious Adverse Event (s), afatinib-related AEs (ADRs) as indicated by incidence seriousness and intensity grade according to United States (US) national cancer institute's (NCI) (CTCAE Version 5.0)		50 months

External Links

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