Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Osimertinib · 1 trial · 2 indications
The MTD is the highest dose at which no more than one instance of a dose-limiting toxicity is observed among the 6 participants treated.
Less than or at least 1 out of 6 at highest dose level below the maximal administered dose. If 0 of these 3 additional participants experience a dose limiting toxicity (DLT) (1 of 6), proceed to the next dose level. If 1 or more of the 3 additional participants experience DLT (2 of 6), then dose escalation is stopped, and this dose is declared the maximal administered dose (highest dose administered). Three (3) additional participants will be entered at the next lowest dose level if only 3 participants were treated previously at that dose.
The proportion of participants experiencing an adverse event classified as an SAE will be reported by grade and type according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5, with exact 95% confidence intervals
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Closed to Enrollment) | EXPERIMENTAL | Patients will continue to receive osimertinib 80 mg PO daily as part of standard of care therapy during screening and study treatments. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose will be 30 mg twice daily (dose level 1). All patients at a given dose level must complete the DLT period before any additional cohorts can be opened. |
| Dose Expansion: Cohort A | EXPERIMENTAL | Stage IV EGFR-mutant NSCLC currently receiving and progressing on osimertinib who have received no more than one additional line of systemic cancer therapy other than osimertinib (e.g., chemotherapy +/- immunotherapy, amivantamab +/- Lazertinib) for metastatic disease. Patients may receive alisertib therapy until lack of clinical benefit or intolerable toxicity. |
| Dose Expansion: Cohort B | EXPERIMENTAL | Stage IV EGFR-mutant NSCLC patients who are currently receiving first line osimertinib treatment and have received at least 3 months, but no more than 6 months, of osimertinib with a best response of PR or SD. Patients may receive alisertib therapy until lack of clinical benefit or intolerable toxicity. |
| Dose Expansion: Cohort C | EXPERIMENTAL | Stage IV EGFR-mutant NSCLC patients with no known tumor non-synonymous TP53 genomic alteration who are currently receiving first line osimertinib treatment and have received at least 3 months, but no more than 6 months, of osimertinib with a best response of PR or SD. Patients may receive alisertib therapy until lack of clinical benefit or intolerable toxicity. |
| Name | Type | Description |
|---|---|---|
| Osimertinib | DRUG | Osimertinib is a medication used to treat non-small-cell lung carcinomas with a specific mutation. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. Patients will be receiving full dose osimertinib (80 mg PO daily) as part of the patient's current standard of care. |
| Alisertib | DRUG | Alisertib is an orally available selective aurora A kinase inhibitor. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose for Cohort 1 will be 30 mg twice daily (dose level 1). |
Inclusion Criteria: 1. Patients must have histologically confirmed stage IV non-small cell lung cancer. 2. Male or female patients \>=18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Documented activating EGFR mutation (Exon 19 deletion, Exon 19 insertion, ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Pfizer Inc. | PFE | 1 | PHASE1 | TG4001, Avelumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Oncolytics Biotech Inc. | ONCY | 1 | PHASE1 | Pelareorep, Atezolizumab, Gemcitabine and nab-paclitaxel, Trifluridine Tipiracil, mFOLFIRINOX Treatment Regimen |
| TScan Therapeutics, Inc. | TCRX | 1 | PHASE1 | TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-203-A0201, TSC-204-A0101 |
Osimertinib is being studied for use in metastatic lung cancer, specifically in patients with EGFR gene mutations. It is an investigational small molecule being evaluated in combination with another drug, alisertib, in a Phase 1 clinical trial. The trial is recruiting patients in the United States.
Osimertinib is being developed by Puma Biotechnology Inc, a biopharmaceutical company traded on NASDAQ under the ticker PBYI. The company is conducting a Phase 1 clinical trial of osimertinib in combination with alisertib for metastatic EGFR-mutant lung cancer.
Osimertinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is studying osimertinib in combination with alisertib for metastatic EGFR-mutant lung cancer.
Osimertinib is being studied in one active clinical trial, NCT04085315, titled 'Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer.' This Phase 1 trial is recruiting 38 participants in the United States and is not randomized or double-blinded.
Osimertinib is a small molecule that belongs to the -tinib class of kinase inhibitors. It is being studied in patients with EGFR gene mutations, indicating it targets the EGFR kinase pathway. The drug is being evaluated in combination with alisertib for metastatic lung cancer.
No, Osimertinib is not the same as alisertib. Osimertinib is the investigational drug being developed by Puma Biotechnology Inc, while alisertib is a separate drug used in combination with osimertinib in the clinical trial NCT04085315 for metastatic EGFR-mutant lung cancer.