Aurora A Kinase Inhibitor LY3295668 for Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Advanced Lung Non-Squamous Non-Small Cell Carcinoma+11 More
Aurora A Kinase Inhibitor LY3295668 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating the side effects and best dose of a drug that may stop the growth of tumor cells.

See full description

Eligible Conditions

  • Advanced Lung Non-Squamous Non-Small Cell Carcinoma
  • Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
  • Stage IVB Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Study Objectives

This trial is evaluating whether Aurora A Kinase Inhibitor LY3295668 will improve 1 primary outcome and 3 secondary outcomes in patients with Advanced Lung Non-Squamous Non-Small Cell Carcinoma. Measurement will happen over the course of Date of treatment started until the criteria for disease progression is met, assessed at 6 months after treatment.

Month 6
Overall survival
Month 6
Progression-free survival
Day 30
Dose-limiting toxicity and recommended phase 2 dose
Month 6
Best objective response rate

Trial Safety

Safety Progress

1 of 3

Other trials for Advanced Lung Non-Squamous Non-Small Cell Carcinoma

Trial Design

1 Treatment Group

Treatment (osimertinib, aurora A kinase inhibitor LY3295668)
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Aurora A Kinase Inhibitor LY3295668 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (osimertinib, aurora A kinase inhibitor LY3295668)Patients receive osimertinib PO QD and aurora A kinase inhibitor LY3295668 PO BID on days 1-28. Treatment repeats every 28 days for 24 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after last dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 30 days after last dose for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Age ≥ 18 years at the time of consent.
You have histologically or cytologically confirmed non-squamous, non-small cell lung cancer. show original
Locally advanced or metastatic disease.
NSCLC which harbours EGFR Exon 19 deletion.
NSCLC which harbours EGFR L858R mutation. EGFR deletion/mutation must be documented by a Clinical Laboratory Improvement Amendments (CLIA) certified test (either from tissue or ctDNA from blood is allowed)
The patient must have received a third-generation EGFR TKI treatment, regardless of the T790M status. The patient must have progressed on osimertinib, or an equivalent third-generation EGFR TKI with regulatory approval.
You have a performance status of 0-2 (appendix A). show original
At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline at equal or greater than 10mm in the longest dimension by RECIST 1.1.
You are able to take pills or capsules by mouth. show original

Patient Q&A Section

What are the chances of developing carcinoma, non-small-cell lung?

"For men in the early 20s who had never smoked, there was a 26% chance of developing NSCLC within 10 years of diagnosis. The risk increased with smoking status; 34% of current smokers developed NSCLC compared with 18% of ex-smokers." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, non-small-cell lung spread?

"The overall 5-year survival rate was 17.5%, which was lower than the national average. Survival rates were better in the earlier years after diagnosis, but declined later. Patients diagnosed in more recent years had poorer survival compared to older patients." - Anonymous Online Contributor

Unverified Answer

Does carcinoma, non-small-cell lung run in families?

"The similarity between spontaneous and familial nonsmoking carcinomas suggests that their genetic susceptibility depends on environmental factors in addition to hereditary ones. This indicates that age at diagnosis is a better predictor of prognosis than family history of lung cancer." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in aurora a kinase inhibitor ly3295668 for therapeutic use?

"Results from a recent clinical trial suggest that Aurora A inhibitors such as Ly3295668 may serve as novel anti-cancer agents and as a novel class of therapeutics for treating cancers associated with the deregulation of the Aurora A pathway." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma, non-small-cell lung be?

"The survival rate for patients with carcinoma, non-small-cell lung without metastases was poorer than that for those with distant metastases. In addition, the risk factors of death were different between patients with carcinoma, non-small-cell lung without metastases and those with distant metastases." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma, non-small-cell lung?

"Small cell carcinoma of the lung has a dismal prognosis. Survival rates based on stage of disease (TNM classification) were analyzed. The survival rate of T1a small cell carcinoma was 11%. The survival rates of T1b and T2 tumors were 14% and 31%, respectively; and those of T3 and T4 tumors were 21% and 16%, respectively. In addition to TNM staging system, other factors such as the presence of visceral metastasis and the presence of brain metastasis should also be considered. The overall 5-year survival rate for small cell carcinoma of the lung is 19%. We believe that this information may help physicians to counsel patients regarding their prognosis and to provide appropriate expectations." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of aurora a kinase inhibitor ly3295668?

"In a recent study, we observed that the most common side effects were fatigue, rash, dizziness, nausea, headache, and insomnia. These side effects were mild to moderate in severity and generally reversible upon discontinuation of therapy. No unexpected side effects were reported. The present data provide valuable information regarding the expected pharmacokinetics and safety profile of aurora A kinase inhibitors." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

"The authors' findings support the role of clinical trials for NSCLC; however, they emphasize an important limitation of the study: the lack of a control arm in the propensity score analyses. They conclude that there are no specific criteria to determine who should be offered clinical trials for NSCLC." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving aurora a kinase inhibitor ly3295668?

"Findings from a recent study of clinical trial NCT02088982 seem to suggest that Aurora A kinase inhibition might be more effective than standard chemotherapy in NSCLC patients and it needs further evaluation in combination with platinum chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is aurora a kinase inhibitor ly3295668?

"Aurora A kinase inhibition was shown to have significant antitumor activity in both xenografts and primary tumors from NSCLC patients, supporting further development of Aurora A inhibitors as novel therapeutics against this disease." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

"In this review, researchers consider the effectiveness of different therapies and the most effective agents to treat carcinomas, non-small-cell lung. Data from a recent study show that the combination therapy has better efficacy than single agent therapy or monotherapy. Moreover, the curative effect is dependent on the type of tumor, the stage, and the degree of metastasis. Additionally, the combination therapy has better efficacy than monotherapy and the two-drug combination therapy has better efficacy than a single agent regimen. There are many types of therapy, and the best therapy depends on the probability of survival in each case. Finally, we summarize the most recent research of carcinoma, non-small-cell lung." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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