Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Afatinib · 1 trial · 4 indications
ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. |
| Arm 2 | EXPERIMENTAL | Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. |
| Arm 3 | EXPERIMENTAL | Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. |
| Arm 4 | EXPERIMENTAL | Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. |
| Name | Type | Description |
|---|---|---|
| Afatinib | DRUG | 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. |
| Regorafenib | DRUG | 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. |
| Cabozantinib | DRUG | 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. |
Inclusion Criteria: 1. Patients with a histologically or cytologically confirmed diagnosis of one of the following tumor types whose disease has progressed following one line of standard therapy and/or for which no standard treatment is available that has been shown to prolong survival: 1. Non-...
Afatinib is a small molecule being studied for use in Non-small Cell Lung Carcinoma. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in a completed clinical trial that included patients with this condition, among other tumor types.
Afatinib is being developed by Exelixis, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol EXEL. The company is conducting clinical research on this small molecule for the treatment of Non-small Cell Lung Carcinoma.
Afatinib is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial involving Afatinib has been completed, and the drug remains under investigation for Non-small Cell Lung Carcinoma.
Afatinib was studied in clinical trial NCT02795156, titled "Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations." This Phase 2 trial enrolled 100 participants and included patients with Non-small Cell Lung Carcinoma, Urothelial Carcinoma, Gastrointestinal Carcinoma, Non-colon, and Upper Aerodigestive Tract Carcinoma. The trial was conducted in the United States and has been completed.
Afatinib is being studied in a biomarker-selected patient population. The clinical trial NCT02795156 evaluated molecularly matched targeted therapies based on genomic alterations, indicating that Afatinib's use is guided by specific biomarkers in patients with Non-small Cell Lung Carcinoma.