An observational study in Non-squamous, Non-Small Cell Lung Cancer, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Boehringer Ingelheim · Observational
The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.
6,645 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's enrollment of 805 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patients who were treated with afatinib in the first-line setting in each study site after the launch of Giotrif® on 7 May 2014 on a regular basis; their information will be chosen.
Deceased patients fulfilling the eligibility criteria should be enrolled whenever possible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: afatinib
afatinib
Also known as: Giotrif®
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.
Time frame: From start of afatinib as first line treatment up to 18 months and up to 36 months.
Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)
Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported.
Time frame: From start of afatinib up to 18 months and up to 36 months.
Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)
Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported.
Time frame: From start of afatinib as second line treatment up to 18 months and up to 36 months.
Overall Survival
If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported.
Time frame: From start of afatinib up to 18 months and up to 36 months.
Time to Initial Dose Reduction of Afatinib
Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported.
Time frame: From start of afatinib up to 18 months and up to 36 months.
Percentage of Participants With Dose Modifications of Afatinib
Percentage of participants with dose modifications of afatinib.
Time frame: From start of data extraction until end of data extraction, up to 586 days.
Non-interventional, multi-center study from existing data of patients treated with afatinib as the first-line treatment. 40 study sites in Japan were planned for participating. Recruitment of patients was stopped at all sites when it was determined that a sufficient number of patients have been enrolled. A maximum of 50 patients were limited for enrolment per site to avoid differential study site influence on study results. Data extraction started on 01 April 2021 and ended on 07 November 2022.
| Milestone | Patients Treated With Afatinib |
|---|---|
| Started | 805 |
| Completed | 85 |
| Not completed | 720 |
| Withdrew: Unkown reason | 7 |
| Withdrew: Death | 17 |
| Withdrew: Other than listed | 19 |
| Withdrew: Adverse event | 143 |
| Withdrew: Progressive disease | 512 |
| Withdrew: Unknown if patients were still on treatment at end of observation period | 22 |
Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.
| Proportion of participants | Patients Treated With Afatinib |
|---|---|
| At 18 months | 0.39 (0.35 to 0.42) |
| At 36 months | 0.15 (0.12 to 0.17) |
Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported.
| Proportion of participants | Patients Treated With Afatinib |
|---|---|
| At 18 months | 0.58 (0.54 to 0.61) |
| At 36 months | 0.30 (0.27 to 0.34) |
Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported.
| Proportion of participants | Patients Treated With Afatinib |
|---|---|
| At 18 months | 0.17 (0.14 to 0.20) |
| At 36 months | 0.09 (0.07 to 0.12) |
If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported.
| Proportion of participants | Patients Treated With Afatinib |
|---|---|
| At 18 months | 0.80 (0.78 to 0.83) |
| At 36 months | 0.54 (0.51 to 0.58) |
Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported.
| Proportion of participants | Patients Treated With Afatinib |
|---|---|
| At 18 months | 0.22 (0.19 to 0.26) |
| At 36 months | 0.20 (0.16 to 0.24) |
Percentage of participants with dose modifications of afatinib.
| Percentage of participants | Patients Treated With Afatinib |
|---|---|
| Percentage of Participants With Dose Modifications of Afatinib | 73.7 |
Collected over Adverse events and deaths were collected for approximately 8.5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Treated With Afatinib | 486/805 (60.4%) | 8/805 (1%) | 43/805 (5.3%) |
| Event | Patients Treated With Afatinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 2/805 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 2/805 |
| Acute myocardial infarctionCardiac disorders | 1/805 |
| Anaphylactic reactionImmune system disorders | 1/805 |
| FallInjury, poisoning and procedural complications | 1/805 |
| Decreased appetiteMetabolism and nutrition disorders | 1/805 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/805 |
| RashSkin and subcutaneous tissue disorders | 1/805 |
| Event | Patients Treated With Afatinib |
|---|---|
| NasopharyngitisGastrointestinal disorders | 43/805 |
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
| Age, Continuous(Years) | Patients Treated With Afatinib |
|---|---|
| Mean | 65.8 ± 10.5 |
| Sex: Female, Male(Participants) | Patients Treated With Afatinib |
|---|---|
| Female | 440 |
| Male | 365 |
| Race/Ethnicity, Customized(Participants) | Patients Treated With Afatinib |
|---|---|
| Japanese | 799 |
| Other Asian | 4 |
| Non-Asian | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Ran from Aug 2021 to primary completion in Oct 2023, 25 months.
Results were first posted in Dec 2024, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung →