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Osimertinib First-Line · 1 trial · 1 indication
Objective Response Rate will be determined using investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Objective Response Rate is the percent of subjects with measurable disease with at least one visit response of complete response or partial response.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | First-line treatment = osimertinib, 80 mg, oral, daily; Second-line treatment = platinum (carboplatin or cisplatin) + pemetrexed chemotherapy, prescribed as per institutional standards; Third-line treatment = osimertinib rechallenge, 80 mg, oral, daily. Patients may enter the study at first-line treatment, second-line treatment, or third-line treatment. This is dependent on meeting the eligibility criteria. |
| Name | Type | Description |
|---|---|---|
| Osimertinib First-Line | DRUG | Osimertinib, 80 mg, oral, daily |
| Platinum + Pemetrexed Chemotherapy Second-Line | DRUG | Platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed are prescribed as per institutional standards. |
| Osimertinib Third-Line | DRUG | Rechallenge with osimertinib, 80 mg, oral, daily |
Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Male or female patients of at least 18 years of age * Pathologically proven advanced non-small cell lung cancer (i.e. stage M1 (metastasis), or earlier stages if unfit or unsuitable for radical treatment). ...
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Osimertinib First-Line is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is a kinase inhibitor, part of the -tinib class of drugs. The drug is being evaluated in a Phase 2 clinical trial for patients with EGFR-mutated lung cancer.
Osimertinib First-Line targets kinases, as it belongs to the -tinib class of kinase inhibitors. It is being studied in biomarker-selected patients with EGFR-mutated Non-Small Cell Lung Cancer, indicating its mechanism is directed at tumors with EGFR mutations.
Osimertinib First-Line is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with Non-Small Cell Lung Cancer.
Osimertinib First-Line is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received Priority Review designation from the FDA, indicating expedited review status, but it remains in active clinical testing.
Osimertinib First-Line is being studied in one active Phase 2 clinical trial with the identifier NCT04335292. The trial is titled 'Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge' and is recruiting 200 participants in Canada with Non-Small Cell Lung Cancer.
Osimertinib First-Line is a specific formulation or regimen of osimertinib, the active drug. The trial NCT04335292 evaluates osimertinib given first-line, followed by chemotherapy, and then a third-line rechallenge with osimertinib in EGFR-mutated lung cancer. It is the same molecular entity, osimertinib, studied in a particular treatment sequence.