A Phase 4 interventional study of Afatinib in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Completed at 21 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment
The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Afatinib tablet once daily until progression
Drug: Afatinib
Afatinib tablet once daily until progression
Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Time frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
An open-label, single-arm phase IV study to assess the efficacy and safety of Afatinib as second-line therapy for patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harbouring an Epidermal Growth Factor Receptor(EGFR) mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy.
| Milestone | Afatinib 40 mg |
|---|---|
| Started | 60 |
| Completed | 0 |
| Not completed | 60 |
| Withdrew: Clinical symptoms of progression | 2 |
| Withdrew: Progression disease according to recist | 24 |
| Withdrew: Adverse event | 12 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Switched to commercial afatinib | 20 |
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions
| Percentage of participants | Afatinib 40 mg |
|---|---|
| Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1 | 50 (36.8 to 63.2) |
Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.
| Months | Afatinib 40 mg |
|---|---|
| Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1. | 10.94 (6.44 to 13.20) |
As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
| Percentage of participants | Afatinib 40 mg |
|---|---|
| Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1 | 83.3 (71.5 to 91.7) |
Collected over From first drug administration until 28 days after last drug administration, up to 830 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Afatinib 40 mg | 11/60 (18.3%) | 21/60 (35%) | 56/60 (93.3%) |
| Event | Afatinib 40 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 4/60 |
| PneumoniaInfections and infestations | 2/60 |
| Brain oedemaNervous system disorders | 2/60 |
| SeizureNervous system disorders | 2/60 |
| Acute kidney injuryRenal and urinary disorders | 2/60 |
| Cardiac arrestCardiac disorders | 1/60 |
| Blood creatinine increasedInvestigations | 1/60 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/60 |
| Malignant pleural effusionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/60 |
| EpilepsyNervous system disorders | 1/60 |
| Event | Afatinib 40 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 44/60 |
| RashSkin and subcutaneous tissue disorders | 18/60 |
| ParonychiaInfections and infestations | 14/60 |
| HypokalaemiaMetabolism and nutrition disorders | 13/60 |
| AnaemiaBlood and lymphatic system disorders | 12/60 |
| NauseaGastrointestinal disorders | 12/60 |
| Mucosal inflammationGeneral disorders | 12/60 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 9/60 |
| FatigueGeneral disorders | 9/60 |
| VomitingGastrointestinal disorders | 6/60 |
Treated Set (TS): The TS includes all patients who were documented to have taken at least 1 dose of afatinib.
| Age, Continuous(Years) | Afatinib 40 mg |
|---|---|
| Mean | 59.9 ± 9.8 |
| Sex: Female, Male(Participants) | Afatinib 40 mg |
|---|---|
| Female | 33 |
| Male | 27 |
| Race (NIH/OMB)(Participants) | Afatinib 40 mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 19 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Boehringer Ingelheim