Non-Small Cell Lung CancerNCT04909073
Observational Study of Afatinib 30 mg Daily
An observational study of Non-Small Cell Lung Cancer and Epidermal Growth Factor Receptor Mutation, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Afatinib, a first-in-class irreversible ErbB family blocker, is a 1st line treatment option for patients with advanced stage NSCLC harbouring sensitizing EGFR mutations. In randomized 1st line studies of afatinib at a standard dose of 40 mg daily versus standard of care, 28-53% of patients required a dose reduction… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor Mutation
- What is being tested?
- Afatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 69 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Oct 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who has taken 30 mg Afatinib as initial dose and still on treatment for less than 28 days
Who may be able to join
- Age ≥18 years.
- ECOG performance status 0-1.
- Pathologically confirmed diagnosis of Stage IIIB/IV adenocarcinoma of the lung.
- Have been commenced on first line afatinib 30 mg within 4 weeks of study enrolment.
- Documented EGFR mutation(s)-positive NSCLC (common mutations: Del19 and L858R) from tumour biopsy material. Results of EGFR mutation test must be available before taking Afatinib.
- A CT thorax/ abdomen within 4 weeks of study enrolment with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
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- No brain metastases (confirmed by a CT or MRI brain performed within 4 weeks of study enrolment)
- Documented adequate organ function before taking Afatinib:
- Absolute neutrophil count (ANC) ≥1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the Investigator and in discussion with the sponsor-Investigator).
- Platelet count ≥75,000/mm3.
- Estimated creatinine clearance using Cockcroft Gault calculation of at least 45 ml/min.
- Total Bilirubin ≤1.5 times upper limit of (institutional/central) normal (Patients with Gilbert's syndrome total bilirubin must be ≤4 times institutional upper limit of normal).
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤3 times the upper limit of (institutional/central) normal (ULN) (if related to liver metastases ≤5 times ULN).
- Archived tissue sample is available.
- Written informed consent per regulations.
Who cannot join
- Prior chemotherapy for Stage IIIB/IV adenocarcinoma of the lung. Neo-/adjuvant chemotherapy, CT-RT or RT is permitted if it has been elapsed for =12 months prior to disease progression.
- Prior treatment with EGFR targeting small molecules or antibodies.
- Major surgery within 4 weeks of study treatment.
- Brain metastases.
- Meningeal carcinomatosis.
- Known pre-existing interstitial lung disease (ILD).
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- Patients with a significant disease other than lung cancer; a significant disease is defined as a disease which, in the opinion of the investigator, may:
- put the patient at risk because of participation in the study
- influence the results of the study
- cause concern regarding the patient's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Nationa University Hospital
Singapore
Ross Soo, MBBS, +65 6908 2222, Ross_Soo@nuhs.edu.sg
Ross Soo, MBBS
About this study
Official title: An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harbouring Common EGFR Mutations Treated With Afatinib
Afatinib, a first-in-class irreversible ErbB family blocker, is a 1st line treatment option for patients with advanced stage NSCLC harbouring sensitizing EGFR mutations. In randomized 1st line studies of afatinib at a standard dose of 40 mg daily versus standard of care, 28-53% of patients required a dose reduction due to adverse events (AE) induced by afatinib. The most common AEs are cutaneous and gastrointestinal (diarrhoea, dysphagia, and mucositis). Prevalence of diarrhoea in patients receiving 40 mg of afatinib, in 1st line phase II and III studies is as high as 90.0% (all grades of diarrhoea) and 14.4% (grade 3-4 diarrhoea). Another important gastrointestinal AE is mucositis, which presents in 51.9%-64.4% of patients treated with afatinib, with only 4.4%-8.3% of the cases being grade 3-4. Dose reduction tended to occur in patients who had higher initial afatinib plasma concentrations and led to decreases in the incidence and severity of afatinib-related AEs without affecting therapeutic efficacy. The incidence of gastrointestinal AEs could be decreased >50% with proper afatinib dose reduction.
The effect of 1st line afatinib 30 mg daily in patients with EGFR mutation-positive NSCLC is unknown. We hypothesize that, in patients with EGFR mutation-positive NSCLC, 1st line afatinib treatment at 30 mg daily is tolerable with less gastrointestinal AEs and with a similar efficacy to standard dose afatinib.
Read the detailed description
This is a multi-country, multi-centre, study designed to collect clinical data and to evaluate efficacy and safety of patients treated with afatinib 30 mg at the Investigator's discretion.
All entered patients (i.e., patients that have been treated with the defined medication) will receive continuous treatment of afatinib in the absence of disease progression or meeting any other withdrawal criteria. All patients will visit Investigator at regular intervals for assessment of efficacy and safety as outlined in the Flow Chart for the first 7 cycles treatment. The Investigator will assess the patient at each visit. Tumour response and progression will be assessed using RECIST 1.1 at the Investigator site.
- Being tested
- Afatinib
- Keywords
- afatinib, EGFR mutation-positive NSCLC
- 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
Continuous treatment of afatinib 30mg tablet once daily in the absence of disease progression or unacceptable treatment-related toxicity, Investigator decision or patient decision to discontinue study treatment.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib 30 mg daily | Oral afatinib 30 mg tablet once daily, continuously Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
To assess the effect of afatinib 30 mg daily at the Investigator's discretion on progression-free survival rate (PFSR) at month 6.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start25 Oct 2022
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909073
- Sponsor's protocol ID
- 1200.0303
- Status last verified
- May 2024
- First submitted
- 26 May 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan DS, Yom SS, Tsao MS, Pass HI, Kelly K, Peled N, Yung RC, Wistuba II, Yatabe Y, Unger M, Mack PC, Wynes MW, Mitsudomi T, Weder W, Yankelevitz D, Herbst RS, Gandara DR, Carbone DP, Bunn PA Jr, Mok TS, Hirsch FR. The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation-Positive Non-Small Cell Lung Cancer: Status in 2016. J Thorac Oncol. 2016 Jul;11(7):946-63. doi: 10.1016/j.jtho.2016.05.008. Epub 2016 May 23.
PubMed 27229180Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.
PubMed 23816960Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
PubMed 25589191Sooi K, Danchaivijtr P, Wong CK, Tu VD, Sachdeva M, Tai BC, Soo RA. An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-Small-Cell Lung Cancer Harboring Common EGFR Mutations Treated With Afatinib. Thorac Cancer. 2026 Jul;17(13):e70331. doi: 10.1111/1759-7714.70331.
PubMed 42381340
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harbouring Common EGFR Mutations Treated With Afatinib
- ClinicalTrials.gov ID
- NCT04909073
- Acronym / sponsor ID
- 1200.0303
- Keywords
- afatinib, EGFR mutation-positive NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Afatinib, a first-in-class irreversible ErbB family blocker, is a 1st line treatment option for patients with advanced stage NSCLC harbouring sensitizing EGFR mutations. In randomized 1st line studies of afatinib at a standard dose of 40 mg daily versus standard of care, 28-53% of patients required a dose reduction due to adverse events (AE) induced by afatinib. The most common AEs are cutaneous and gastrointestinal (diarrhoea, dysphagia, and mucositis). Prevalence of diarrhoea in patients receiving 40 mg of afatinib, in 1st line phase II and III studies is as high as 90.0% (all grades of diarrhoea) and 14.4% (grade 3-4 diarrhoea). Another important gastrointestinal AE is mucositis, which presents in 51.9%-64.4% of patients treated with afatinib, with only 4.4%-8.3% of the cases being grade 3-4. Dose reduction tended to occur in patients who had higher initial afatinib plasma concentrations and led to decreases in the incidence and severity of afatinib-related AEs without affecting therapeutic efficacy. The incidence of gastrointestinal AEs could be decreased >50% with proper afatinib dose reduction.
The effect of 1st line afatinib 30 mg daily in patients with EGFR mutation-positive NSCLC is unknown. We hypothesize that, in patients with EGFR mutation-positive NSCLC, 1st line afatinib treatment at 30 mg daily is tolerable with less gastrointestinal AEs and with a similar efficacy to standard dose afatinib.
Detailed description
This is a multi-country, multi-centre, study designed to collect clinical data and to evaluate efficacy and safety of patients treated with afatinib 30 mg at the Investigator's discretion.
All entered patients (i.e., patients that have been treated with the defined medication) will receive continuous treatment of afatinib in the absence of disease progression or meeting any other withdrawal criteria. All patients will visit Investigator at regular intervals for assessment of efficacy and safety as outlined in the Flow Chart for the first 7 cycles treatment. The Investigator will assess the patient at each visit. Tumour response and progression will be assessed using RECIST 1.1 at the Investigator site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib 30 mg daily | – | Drug: AfatinibOral afatinib 30 mg tablet once daily, continuously |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has taken 30 mg Afatinib as initial dose and still on treatment for less than 28 days
Key inclusion criteria (15 listed)
- Age ≥18 years.
- ECOG performance status 0-1.
- Pathologically confirmed diagnosis of Stage IIIB/IV adenocarcinoma of the lung.
- Have been commenced on first line afatinib 30 mg within 4 weeks of study enrolment.
- Documented EGFR mutation(s)-positive NSCLC (common mutations: Del19 and L858R) from tumour biopsy material. Results of EGFR mutation test must be available before taking Afatinib.
Key exclusion criteria (10 listed)
- Prior chemotherapy for Stage IIIB/IV adenocarcinoma of the lung. Neo-/adjuvant chemotherapy, CT-RT or RT is permitted if it has been elapsed for =12 months prior to disease progression.
- Prior treatment with EGFR targeting small molecules or antibodies.
- Major surgery within 4 weeks of study treatment.
- Brain metastases.
- Meningeal carcinomatosis.
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: GiotrifContinuous treatment of afatinib 30mg tablet once daily in the absence of disease progression or unacceptable treatment-related toxicity, Investigator decision or patient decision to discontinue study treatment. | Drug | Afatinib 30 mg daily |
Primary outcome
Progression-free survival rate
Time frame: 6 months
To assess the effect of afatinib 30 mg daily at the Investigator's discretion on progression-free survival rate (PFSR) at month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Results publication: PubMed 27229180Tan DS, Yom SS, Tsao MS, Pass HI, Kelly K, Peled N, Yung RC, Wistuba II, Yatabe Y, Unger M, Mack PC, Wynes MW, Mitsudomi T, Weder W, Yankelevitz D, Herbst RS, Gandara DR, Carbone DP, Bunn PA Jr, Mok TS, Hirsch FR. The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation-Positive Non-Small Cell Lung Cancer: Status in 2016. J Thorac Oncol. 2016 Jul;11(7):946-63. doi: 10.1016/j.jtho.2016.05.008. Epub 2016 May 23.
- Results publication: PubMed 23816960Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.
- Results publication: PubMed 25589191Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
- Derived from this study: PubMed 42381340Sooi K, Danchaivijtr P, Wong CK, Tu VD, Sachdeva M, Tai BC, Soo RA. An Observational Study of Afatinib 30 mg Daily in Patients With Advanced Non-Small-Cell Lung Cancer Harboring Common EGFR Mutations Treated With Afatinib. Thorac Cancer. 2026 Jul;17(13):e70331. doi: 10.1111/1759-7714.70331.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Epidermal Growth Factor Receptor Mutation, run by National University Hospital, Singapore at 1 site in Singapore.
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 15 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (time frame: 6 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 NCT04909073, which also lists 4 linked publications.
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 17 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.