Product Description
Erlotinib is used to treat certain types of non-small cell lung cancer that has spread to nearby tissues or to other parts of the body in patients who have already been treated with at least one other chemotherapy medication and have not gotten better. Erlotinib is also used in combination with another medication (gemcitabine [Gemzar]) to treat pancreatic cancer that has spread to nearby tissues or to other parts of the body and cannot be treated with surgery. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a605008.html)
Mechanisms of Action: EGFR Inhibitor, TK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Active Clinical Trial Count: 17
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Mucinous Adenocarcinoma|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma|Papillary Adenocarcinoma|Papillary Carcinoma
Phase 2: Abnormalities, Multiple|Biliary Tract Cancer|Bladder Cancer|Breast Cancer|Head and Neck Cancer|Hodgkin Lymphoma|Intestinal Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Oncology Solid Tumor Unspecified|Oncology Unspecified|Renal Cell Carcinoma|Squamous Cell Carcinoma|Vision, Low
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ProTarget | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2029-04-30 |
12% |
2025-07-26 |
Primary Endpoints |
| DRUP | P2 |
Recruiting |
Abnormalities, Multiple|Vision, Low|Lymphoma, Non-Hodgkin|Multiple Myeloma|Lymphoma, B-Cell|Hodgkin Lymphoma |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
| EGFR | P2 |
Recruiting |
Non-Small-Cell Lung Cancer |
2025-12-31 |
12% |
2025-08-05 |
Primary Completion Date|Primary Endpoints|Treatments |
| UR1909 | P2 |
Recruiting |
Renal Cell Carcinoma |
2025-09-05 |
2025-05-02 |
Treatments |
|
| NCI-2014-01390 | P2 |
Completed |
Squamous Cell Carcinoma|Head and Neck Cancer |
2025-01-06 |
12% |
2025-01-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| ROME | P2 |
Completed |
Breast Cancer|Non-Small-Cell Lung Cancer|Intestinal Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
| NCT03110484 | P2 |
Recruiting |
Biliary Tract Cancer |
2023-06-14 |
2022-06-16 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
| My Pathway | P2 |
Completed |
Bladder Cancer |
2023-05-24 |
52% |
2024-02-23 |
Primary Completion Date|Primary Endpoints |
| CUPISCO | P2 |
Completed |
Oncology Unspecified |
2023-02-14 |
12% |
2025-02-05 |
Primary Endpoints |
| NCI-2011-01987 | P3 |
Completed |
Pancreatic Ductal Carcinoma|Mucinous Adenocarcinoma|Papillary Adenocarcinoma|Pancreatic Cancer|Papillary Carcinoma |
2023-12-10 |
2025-10-09 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
| I4C-MC-JTBB | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2024-12-31 |
2025-05-02 |
Treatments |
|
| NRG-LU002 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2023-12-20 |
2025-03-12 |
||
| jRCT2071200082 | P2 |
Active, not recruiting |
Oncology Unspecified |
2023-08-30 |
|||
| CTR20131154 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-04-29 |
Treatments |
|
| I4T-MC-JVCY | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2024-12-16 |
2025-05-02 |
Treatments |
|
| CTR20130929 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-04-29 |
Treatments |
|
| BRISK | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2025-01-31 |
2023-06-16 |
Primary Endpoints|Treatments |
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Type |
Title |
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10/09/2025 |
News Article |
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