Numerous clinical trials spanning Phase 1 through Phase 4 evaluate afatinib dimaleate across oncological indications, including non-small cell lung cancer, advanced refractory solid tumors, urothelial carcinomas, and pancreatic cancer. Supported by industry leaders such as Boehringer Ingelheim, academic research centers, and government bodies like the National Cancer Institute, these studies range from completed and active non-recruiting to actively recruiting and terminated statuses. Investigational strategies focus on combination regimens with targeted therapies in refractory malignancies as well as sequential treatment protocols in lung adenocarcinoma cohorts.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02465060 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma |
National Cancer Institute (NCI) |
2015-08-17 | PHASE2 |
| NCT06897735 | TERMINATED | Lung Cancer; Oral Cancer; Melanoma |
Petrov, Andrey |
2025-11-09 | PHASE1 |
| NCT06302621 | Recruiting | Advanced Solid Tumor|Unresectable Solid Tumor|Metastatic Solid Tumor|Cholangiocarcinoma |
Massachusetts General Hospital|Boehringer Ingelheim|Incyte Corporation |
2024-07-01 | Phase 1 |
| NCT02122172 | TERMINATED | Distal Urethral Cancer; Proximal Urethral Cancer; Recurrent Bladder Cancer; Recurrent Urethral Cancer; Stage III Bladder Cancer; Stage III Urethral Cancer; Stage IV Bladder Cancer; Stage IV Urethral Cancer; Ureter Cancer |
University of Chicago |
2017-09-13 | PHASE2 |
| NCT04814056 | UNKNOWN | NRG1-fused Non-small Cell Lung Cancer |
Shanghai Chest Hospital |
2021-06-01 | PHASE4 |
| NCT02451553 | COMPLETED | Advanced Malignant Solid Neoplasm; Bile Duct Carcinoma; Recurrent Malignant Solid Neoplasm; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer |
University of Washington |
2015-11-05 | PHASE1 |
| NCT05298176 | Recruiting | Non-Small Cell Lung Cancer |
Amsterdam UMC location VUmc |
2022-01-04 | Phase 2 |
| NCT04795245 | Completed | Non-squamous Non-Small Cell Lung Cancer |
Boehringer Ingelheim |
2021-08-26 | -- |
| NCT04497584 | Recruiting | Advanced Squamous Non Small Cell Lung Cancer |
University of Texas Southwestern Medical Center |
2021-08-04 | Phase 2 |
| NCT04439136 | ACTIVE_NOT_RECRUITING | Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2015-08-12 | PHASE2 |
| NCT04413201 | Active not recruiting | Non-squamous NSCLC |
Michael Hopp|Boehringer Ingelheim|Johannes Gutenberg University Mainz |
2020-09-11 | Phase 4 |
| NCT02438722 | COMPLETED | Recurrent Non-Small Cell Lung Carcinoma; Stage IV Non-Small Cell Lung Cancer |
SWOG Cancer Research Network |
2015-05-07 | PHASE2; PHASE3 |
| NCT02364609 | COMPLETED | Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer |
Jonathan Riess |
2015-09-30 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-28)
Check the
Afatinib Dimaleate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.