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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Docetaxel — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Trametinib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Jul 18, 2016

Status verified

Mar 2026

Primary completion

May 15, 2019

Completion

Mar 3, 2027

Study Design

Enrollment

60 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (trametinib, docetaxel)
  Patients receive trametinib PO on days 1-21. Patients also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in All KRAS Mutant Participants [ Time Frame: Up to 3 years ]

Locations (597)

Find similar trials in Anchorage, AK

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