Last reviewed · How we verify
Erlotinib, Temozolomide
This combination uses erlotinib to inhibit EGFR signaling and temozolomide to alkylate DNA, together targeting cancer cell growth and survival.
This combination uses erlotinib to inhibit EGFR signaling and temozolomide to alkylate DNA, together targeting cancer cell growth and survival. Used for Glioblastoma or high-grade glioma (phase 3 trial), EGFR-mutant or EGFR-overexpressing malignancies.
At a glance
| Generic name | Erlotinib, Temozolomide |
|---|---|
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Drug class | EGFR tyrosine kinase inhibitor + alkylating agent |
| Target | EGFR (erlotinib); DNA alkylation (temozolomide) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Erlotinib is a small-molecule tyrosine kinase inhibitor that blocks epidermal growth factor receptor (EGFR) signaling, preventing proliferation in EGFR-dependent cancers. Temozolomide is an alkylating agent that damages DNA and triggers apoptosis. The combination leverages dual mechanisms—targeted inhibition plus chemotherapy—to enhance anti-tumor activity, particularly in brain tumors and other malignancies.
Approved indications
- Glioblastoma or high-grade glioma (phase 3 trial)
- EGFR-mutant or EGFR-overexpressing malignancies
Common side effects
- Rash
- Diarrhea
- Nausea/vomiting
- Myelosuppression
- Fatigue
- Hepatotoxicity
Key clinical trials
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM) (PHASE1, PHASE2)
- Erlotinib in Combination With Temozolomide in Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors (PHASE2)
- Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) (PHASE2)
- A Safety Study in Participants With Advanced Solid Tumors (PHASE1)
- Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma (PHASE2)
- Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer (PHASE3)
- Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors (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:
- Erlotinib, Temozolomide CI brief — competitive landscape report
- Erlotinib, Temozolomide updates RSS · CI watch RSS
- Tel-Aviv Sourasky Medical Center portfolio CI