Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

2019-09-16 03:26:48 | BioPortfolio


This is a phase I/Ib, open-label, single-center, single-arm study of alisertib and osimertinib for patients with stage IV EGFR-mutated lung cancer, incorporating both a dose escalation and dose-expansion phase


The dose-escalation phase will consist of a modified 3+3 dose escalation and will be open to patients with metastatic lung cancer with an activating EGFR mutation who have progressed on and are currently receiving osimertinib therapy. The dose-escalation and expansion phases will be open to patients who have received any number of therapies as long as they are currently being treated with and tolerating osimertinib 80 mg orally once per day, and who have demonstrated radiographic progression by RECIST 1.1 criteria on their most recent scan.

Primary Objective:

To determine the safety and tolerability of the combination osimertinib + alisertib in patients with advanced EGFR-mutant NSCLC and identify a recommended phase II dose.

Secondary Objectives:

1. To evaluate the clinical efficacy of adding alisertib to osimertinib compared to "historical" data of platinum doublet chemotherapy in patients who have progressed on osimertinib monotherapy.

2. To explore tumor biomarkers, including TPX2, that predict response to osimertinib + alisertib.

3. To evaluate alisertib and osimertinib pharmacokinetics

4. To evaluate the CNS response rate of alisertib + osimertinib

Patients may continue treatment indefinitely until disease progression, intolerance, or other contraindication to study treatment.

Study Design


Lung Cancer Metastatic


Osimertinib, Alisertib


University of California, San Francisco
San Francisco
United States




University of California, San Francisco

Results (where available)

View Results


Published on BioPortfolio: 2019-09-16T03:26:48-0400

Clinical Trials [6900 Associated Clinical Trials listed on BioPortfolio]

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS in...

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastat...

A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers

The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, th...

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer, Coupled to Extensive Translational Studies

Phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or m...

An Open-Label Phase 1/2 Study of INCB039110 in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and tolerability of INCB039110 in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cance...

PubMed Articles [16322 Associated PubMed Articles listed on BioPortfolio]

Osimertinib in a patient with non-small cell lung cancer and renal failure undergoing hemodialysis: a case report.

Osimertinib is a key drug for cancer patients with EGFR mutations. However, there is little information about its safety in cancer patients who require hemodialysis (HD) for chronic renal failure, des...

A Novel Acquired Exon 20 EGFR M766Q Mutation in Lung Adenocarcinoma Mediates Osimertinib Resistance but is Sensitive to Neratinib and Poziotinib: a Brief Report.

Osimertinib is an effective third-generation tyrosine kinase inhibitor (TKI) for EGFR-mutant lung cancers. However, treatment for patients with acquired resistance to osimertinib remains challenging. ...

Osimertinib plus durvalumab versus osimertinib monotherapy in EGFR T790M-positive NSCLC following previous EGFR-TKI therapy: CAURAL brief report.

Osimertinib is a third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Durvalumab is an anti-PD-L1 monoclonal antibody. The Phase III open-label CAURAL trial (NCT0245...

Degradation of MCL-1 by bufalin reverses acquired resistance to osimertinib in EGFR-mutant lung cancer.

Although osimertinib, an EGFR tyrosine kinase inhibitor, has become the standard therapy for treating non-small cell lung cancer (NSCLC) patients with EGFR-activating mutation, upregulation of MCL-1 i...

Systemic Therapy for Locally Advanced and Metastatic Non-Small Cell Lung Cancer: A Review.

Non-small cell lung cancer remains the leading cause of cancer death in the United States. Until the last decade, the 5-year overall survival rate for patients with metastatic non-small cell lung canc...

Medical and Biotech [MESH] Definitions

Tumors or cancer of the LUNG.

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

An estrogen responsive cell line derived from a patient with metastatic human breast ADENOCARCINOMA (at the Michigan Cancer Foundation.)

More From BioPortfolio on "Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Lung Cancer
Lung cancer is the uncontrolled cell growth in tissues of the lung. Originating in the lungs, this growth may invade adjacent tissues and infiltrate beyond the lungs. Lung cancer, the most common cause of cancer-related death in men and women, is respons...

Searches Linking to this Trial