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Aumolertinib Oral Tablet
Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation.
Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor that selectively targets EGFR mutations, including T790M resistance mutations, to inhibit tumor cell proliferation. Used for Non-small cell lung cancer with EGFR T790M mutation (acquired resistance), Non-small cell lung cancer with EGFR activating mutations (L858R, exon 19 deletions).
At a glance
| Generic name | Aumolertinib Oral Tablet |
|---|---|
| Also known as | Stereotactic Radiation Therapy |
| Sponsor | Shanghai Cancer Hospital, China |
| Drug class | EGFR tyrosine kinase inhibitor (third-generation) |
| Target | EGFR (Epidermal Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Aumolertinib irreversibly binds to and inhibits the EGFR kinase domain, particularly effective against common activating mutations (L858R, exon 19 deletions) and the acquired T790M resistance mutation that emerges during first- or second-generation EGFR-TKI treatment. By blocking EGFR-mediated signaling, it suppresses downstream pathways driving non-small cell lung cancer cell growth and survival.
Approved indications
- Non-small cell lung cancer with EGFR T790M mutation (acquired resistance)
- Non-small cell lung cancer with EGFR activating mutations (L858R, exon 19 deletions)
Common side effects
- Diarrhea
- Rash
- Nausea
- Vomiting
- Fatigue
- Decreased appetite
Key clinical trials
- A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer (PHASE1)
- A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer (PHASE2, PHASE3)
- A Study Evaluating the Effect of Aumolertinib on the Pharmacokinetics of Midazolam in Patients With NSCLC (PHASE1)
- Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers (PHASE1)
- Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer (PHASE3)
- A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation (NA)
- A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- Aumolertinib Adjuvant Therapy of Resectable Stage I EGFRm+ NSCLC With High-grade Patterns (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aumolertinib Oral Tablet CI brief — competitive landscape report
- Aumolertinib Oral Tablet updates RSS · CI watch RSS
- Shanghai Cancer Hospital, China portfolio CI