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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04206787
• Collaborator: (none)
• Enrollment: 76
• Locations: 10
• Anticipated Duration (Months): 75.3
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-squamous, Non-Small Cell Lung Cancer	Drug: Afatinib

Study Design

• Study Type: Observational
• Actual Enrollment: 76 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: May 20, 2020
• Anticipated Primary Completion Date: Aug 30, 2026
• Anticipated Study Completion Date: Aug 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with non-small cell lung cancer (NSCLC)	Drug: Afatinib; drug; Other Names: Giotrif®

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. Overall Survival from the start of afatinib until the date of death [50 months]

3. Progression-Free Survival as judged by an investigator with afatinib in first-line treatment [33 months]

4. Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1 [33 months]

5. Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1 [33 months]

6. Proportion of resistance mechanisms after afatinib first-line [12 months]

7. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China	100730
2	West China Hospital	Chengdu		China	610041
3	The First Afiliated Hospital, Sun Yet-sen University	Guangzhou		China	510080
4	First Affiliated Hospital of Guangzhou Medical University	Guangzhou		China	510120
5	Hainan Cancer Hospital	Haikou		China	570312
6	The First Affiliated Hospital, Zhejiang University	Hangzhou		China	310003
7	China Shenyang Chest Hospital	Shenyang		China	110000
8	Shenzhen People's Hospital	Shenzhen		China	518020
9	The First Affiliated Hospital of Zhengzhou Unviersity	Zhengzhou		China	450052
10	Zhongshan People's Hospital	Zhongshan		China	528403

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04206787
• Other Study ID Numbers: 1200-0318
• First Posted: Dec 20, 2019
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Afatinib

Study Results

No Results Posted as of Aug 10, 2022