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RECRUITING Phase 1

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

NCT04085315 · View on ClinicalTrials.gov ↗

Study Summary

This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and/or bad, it has on EGFR-mutated lung cancer.

Interventions

  • DRUG Osimertinib
  • DRUG Alisertib

Study Locations (1)

California

  • University of California, San Francisco — San Francisco

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-11-12
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Collin Blakely

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04085315

The ClinicalTrials.gov registry entry for NCT04085315 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Collin Blakely, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with EGFR Gene Mutation appearing as the primary indexed condition, and to 2 interventions — of which Osimertinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04085315 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04085315 about?

NCT04085315 is a clinical study titled "Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer". This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be im...

What is the current status of trial NCT04085315?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-11-12. Estimated completion is 2026-12-31.

What conditions does trial NCT04085315 study?

This clinical trial studies the following conditions: EGFR Gene Mutation, Lung Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04085315?

The interventions under investigation include: Osimertinib (DRUG), Alisertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04085315?

This trial is sponsored by Collin Blakely, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04085315 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial