NCT02642042

Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the response rate (confirmed and unconfirmed) to trametinib plus docetaxel in the entire study population of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive non-small cell lung cancer (NSCLC) patients following one or two prior systemic therapies. 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. II. To assess the response rate of this combination in non-G12C KRAS mutation positive NSCLC patients. III. To assess progression-free survival within the G12C and non-G12C KRAS positive subgroups and the entire study population. IV. To evaluate the toxicity of the regimen. V. To assess overall survival within G12C positive patients, non-G12C positive patients, and the entire study population. TRANSLATIONAL MEDICINE OBJECTIVES: I. To evaluate the response rates in the presence of comutations p53 and LKB1. II. To bank specimens for future research. OUTLINE: Patients receive trametinib orally (PO) on days 1-21. Patients also receive docetaxel intravenously (IV) on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

• KRAS Gene Mutation
• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Docetaxel	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Trametinib	Given PO

Timeline

• Start date: 2016-07-18
• Primary completion: 2019-05-15
• Completion: 2026-03-19
• First posted: 2015-12-30
• Last updated: 2026-03-04
• Results posted: 2021-02-02

Locations

599 sites across 1 country: United States

Regulatory

• FDA-regulated drug study