SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02642042

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Trial of Trametinib With Docetaxel in Patients With KRAS Mutation Positive Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease Following One or Two Prior Systemic Therapies

This phase II trial studies how well trametinib and docetaxel work in treating patients with stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come back. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib with docetaxel may work better in treating non-small cell lung cancer.

NCT02642042 KRAS Gene Mutation Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

3 Interventions

Name: Docetaxel

Description: Given IV

Type: Drug

Treatment (trametinib, docetaxel)

Name: Laboratory Biomarker Analysis

Description: Correlative studies

Type: Other

Treatment (trametinib, docetaxel)

Name: Trametinib

Description: Given PO

Type: Drug

Treatment (trametinib, docetaxel)


Primary Outcomes

Measure: Response rate (confirmed and unconfirmed complete and partial responses) in all KRAS mutant patients (both those with G12C mutations and those with non-G12C mutations)

Time: Up to 3 years

Secondary Outcomes

Measure: Response rate in patients with a G12C mutation

Time: Up to 3 years

Description: Progression free survival estimates will be calculated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.

Measure: Progression free survival

Time: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Description: Overall survival estimates will be calculated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.

Measure: Overall survival

Time: Up to 3 years

Description: Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (CTCAE version 5.0 will be utilized for serious adverse event reporting only). Toxicity rates can be estimated to within +/- 14% with 95% confidence.

Measure: Incidence of toxicity

Time: Up to 3 years

Other Outcomes

Description: The response rate between patients with dysfunctional p53 will be compared to the response rate in patients without p53 dysfunction.

Measure: Response rates in the presence of p53 mutations

Time: Up to 3 years

Description: The response rate between patients with LKB1 disruption will be compared to the response rate in patients without LKB1 disruption. The response rate will be estimated by LKB1 disruption status (yes/no), along with 95% confidence intervals around the estimated proportions. This analysis will evaluate if disruption in LKB1 is associated with a lower probability of response.

Measure: Response rates in the presence of LKB1 mutations

Time: Up to 3 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 G12C

Response rate (confirmed and unconfirmed complete and partial responses) in all KRAS mutant patients (both those with G12C mutations and those with non-G12C mutations). --- G12C ---

Response rate (confirmed and unconfirmed complete and partial responses) in all KRAS mutant patients (both those with G12C mutations and those with non-G12C mutations). --- G12C --- --- G12C ---

Response rate in patients with a G12C mutation. --- G12C ---

SECONDARY OBJECTIVES: I. To evaluate if trametinib plus docetaxel is consistent with promise of activity measured by the response rate in G12C KRAS mutation positive NSCLC patients following one or two prior systemic therapies. --- G12C ---

To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients. --- G12C ---

To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population. --- G12C ---

To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population. --- G12C --- --- G12C ---

V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population. --- G12C ---

V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population. --- G12C --- --- G12C ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1