Non-squamous, Non-Small Cell Lung CancerNCT04206787

The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer

An observational study of Non-squamous, Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-squamous, Non-Small Cell Lung Cancer
What is being tested?: Afatinib
Type of treatment: Pill or oral medicine
How many people: 72 participants
Where: 10 sitesChina
Study dates: 20 May 2020to 22 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Eligible patients will be enrolled in this study and will receive afatinib (first-line) and subsequent treatment (second-line) of either 3rd generation EGFR TKI or other treatments

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Peking Union Medical College Hospital
Beijing, 100730
West China Hospital
Chengdu, 610041
The First Afiliated Hospital, Sun Yet-sen University
Guangzhou, 510080
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Hainan Cancer Hospital
Haikou, 570312
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
China Shenyang Chest Hospital
Shenyang, 110000
Shenzhen People's Hospital
Shenzhen, 518020
The First Affiliated Hospital of Zhengzhou Unviersity
Zhengzhou, 450052
Zhongshan People's Hospital
Zhongshan, 528403

Other trials in China

About this study

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

Conditions: Non-squamous, Non-Small Cell Lung Cancer
Being tested: Afatinib
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AfatinibDrug
Also called Giotrif®
drug

Study groups in NCT04206787
Study group	Role	What they receive
Afatinib-treated patients		Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy. Receives: Drug: Afatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib.
The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.
Measured: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.

Secondary outcomes (5)

Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up
Overall survival (OS) is defined as the time from the start of afatinib until death for any reason. Subjects who have not died at the time of the statistical analysis were censored at the time they had the last known afatinib contact.
The median survival time was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method. The median OS was not estimable due to the limited number of death events.
Measured: From first afatinib administration until death, or censoring date. Up to approximately 41 months.
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 by Investigator Review With Afatinib in First-line Treatment
The objective response rate (ORR) is defined as the percentage of subjects treated with first-line afatinib with best overall response of complete response (CR), defined by the disappearance of all target lesions, and partial response (PR), defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The tumor response was evaluated by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
The Clopper-Pearson method was used to provide an estimation of the ORR with 95% confidence interval.
Measured: From first afatinib administration until earliest RECIST progression (progressive disease (PD) or death) or the last evaluable assessment in the absence of RECIST progression (PD or death). Up to approximately 40 months.
Number of Patients With Any Adverse Event (AE)
Number of patients treated with first-line afatinib with any adverse event.
Measured: From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months.
Number of Patients With Treatment-emergent Serious Adverse Events (SAE)
Number of patients treated with first-line afatinib with treatment emergent serious adverse events (SAEs). SAEs are untoward medical occurrences that result in death, are life threatening, require inpatient hospitalisation, require prolongation of existing hospitalisation, result in persistent or significant disability/incapacity, result in a congenital anomaly/birth defect, or are deemed serious for any other medically important reason.
Measured: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.
Number of Patients With Any Afatinib-related Adverse Events (AE)
Number of patients treated with first-line afatinib with any adverse event associated with the use of afatinib.
Measured: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202022 Dec 2023

First posted20 Dec 2019
Study start20 May 2020
Primary completion18 Dec 2023
Study completion22 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-squamous, Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04206787
Sponsor's protocol ID: 1200-0318
Status last verified: Feb 2025
First submitted: 11 Dec 2019
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.The data shared are the raw clinical study data sets.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

All Non-squamous, Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-world Study on Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT04206787
Acronym / sponsor ID: 1200-0318
Conditions: Non-squamous, Non-Small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 May 2020 (actual)
Primary completion: 18 Dec 2023 (actual)
Study completion: 22 Dec 2023 (actual)
First posted: 20 Dec 2019 (actual)
Results: Posted 28 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Afatinib-treated patients	–	Drug: AfatinibChinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Eligible patients will be enrolled in this study and will receive afatinib (first-line) and subsequent treatment (second-line) of either 3rd generation EGFR TKI or other treatments

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AfatinibAlso: Giotrif®drug	Drug	Afatinib-treated patients

Primary outcome

Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Time frame: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.
Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib. The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.

5 secondary outcomes

Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up
Time frame: From first afatinib administration until death, or censoring date. Up to approximately 41 months.
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 by Investigator Review With Afatinib in First-line Treatment
Time frame: From first afatinib administration until earliest RECIST progression (progressive disease (PD) or death) or the last evaluable assessment in the absence of RECIST progression (PD or death). Up to approximately 40 months.
Number of Patients With Any Adverse Event (AE)
Time frame: From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months.
Number of Patients With Treatment-emergent Serious Adverse Events (SAE)
Time frame: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.
Number of Patients With Any Afatinib-related Adverse Events (AE)
Time frame: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.

Results and safety

Results posted to the registry on 28 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Afatinib-treated Patients	72	26

Primary outcome: Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Time frame: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.. Median (90% Confidence Interval). Unit: Months

Measure	Afatinib-treated Patients n = 72
Value	14.4 (11.27 to 18.07)

Population analysed: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Afatinib-treated Patients	10 of 72 (13.9%)	65 of 72 (90.3%)	25 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.The data shared are the raw clinical study data sets.

Related trials for Non-squamous, Non-Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-squamous, Non-Small Cell Lung Cancer, run by Boehringer Ingelheim at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation (time frame: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.