Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Osimertinib · 1 trial · 4 indications
Progression free survival (PFS) time will be calculated from the date of randomization to disease progression or death from any cause, whichever occurs the first.
| Arm | Type | Description |
|---|---|---|
| Arm A (Osimertinib and Ramucirumab) | ACTIVE_COMPARATOR | Osimertinib and Ramucirumab |
| Arm B (Osimertinib) | ACTIVE_COMPARATOR | Osimertinib |
| Name | Type | Description |
|---|---|---|
| Osimertinib | DRUG | Osimertinib 80 mg orally on Day 1 |
| Ramucirumab | DRUG | Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes |
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age ≥ 18 years at the time of consent. * Histologically or cytological...
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Osimertinib is an investigational small molecule being studied for the treatment of Non Small Cell Lung Cancer (NSCLC). It is currently in Phase 2 clinical development, evaluated in patients with locally advanced or metastatic NSCLC that harbors an EGFR gene mutation.
Osimertinib targets the epidermal growth factor receptor (EGFR), acting as an inhibitor of this molecular target. By inhibiting EGFR, it is designed to interfere with signaling pathways that drive cancer cell growth in EGFR-mutated Non Small Cell Lung Cancer.
Osimertinib is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is currently conducting clinical trials to evaluate the drug's safety and efficacy in Non Small Cell Lung Cancer.
Osimertinib is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, studying the drug in patients with EGFR-mutated Non Small Cell Lung Cancer.
Osimertinib is being studied in one active Phase 2 clinical trial with the identifier NCT03909334. This trial, titled 'Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)', enrolls approximately 160 participants in the United States.