Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation Positive Non-small Cell Lung Cancer (NCT02642042)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. DISEASE RELATED CRITERIA: Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive non-small cell lung cancer (NSCLC) that is stage IV or recurrent; the specific subtype of KRAS mutation must be known; KRAS mutation testing must have been performed in a Clinical Laboratory Improvement Act (CLIA) certified laboratory; CLIA certified commercially available tests are acceptable
2. DISEASE RELATED CRITERIA: Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 days prior to registration; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\])
3. DISEASE RELATED CRITERIA: Patients must not have known brain metastases, leptomeningeal carcinomatosis or spinal cord compression unless: (1) metastases have been locally treated (including stereotactic body radiation therapy \[SBRT\], whole brain radiotherapy \[WBRT\], and surgical resection) and have remained clinically controlled and asymptomatic for at least 14 days following treatment and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 2 days prior to registration
4. PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have documented progressive cancer following at least one but no more than two prior regimens of systemic therapy for lung cancer, one of which must have been platinum based combination chemotherapy; treatment with an immune therapy or targeted therapy for advanced disease will be considered a separate regimen and will count toward the prior regimens; maintenance therapy will not be counted as a separate regimen; adjuvant chemotherapy or chemotherapy administered as part of concurrent chemotherapy and radiation therapy for the treatment of lung cancer will not count as a prior regimen of systemic therapy as long as recurrence of patient's lung cancer occurred more than 12 months after the last day of chemotherapy
5. PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration. Patients must have recovered from any adverse events to Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 prior to registration
6. PRIOR/CONCURRENT THERAPY CRITERIA: Prior treatment with an anti-PD-1 or anti-PDL1 is not required
7. PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have received prior docetaxel; patients must not have received therapy with a drug known to be either a mitogen-activated protein kinase (MEK) inhibitor or a phosphatidylinositol 3 kinase (PI3K)/v-akt murine thymoma viral oncogene homolog 1 (AKT)/mammalian target of rapamycin (mTOR) pathway inhibitor
8. PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have recovered from any adverse effects from prior therapy (except alopecia) to =\< CTCAE grade 1 prior to registration
9. PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have had prior radiation therapy as long as it has not affected greater than 25% of the bone marrow and at least one measurable lesion is outside the area of prior radiation; at least 7 days must have elapsed since last radiation treatment; patients must have recovered from any adverse events from prior radiation therapy to =\< CTCAE grade 1
10. PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have had a major surgery within 28 days prior to registration; patients must have recovered from any adverse effects of prior surgery to the satisfaction of the treating physician; biopsies and central IV access placement are not considered major surgery
11. PRIOR/CONCURRENT THERAPY CRITERIA: Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John's wort, kava, ephedra \[ma huang\], ginko biloba, dehydroepiandrosterone \[DHEA\], yohimbe, saw palmetto, or ginseng)
12. CLINICAL/LABORATORY CRITERIA: Patients must have Zubrod performance status of 0-2

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (596 Sites)

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
• PCR Oncology — Arroyo Grande, California
• Sutter Auburn Faith Hospital — Auburn, California
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Mills-Peninsula Medical Center — Burlingame, California
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
• Eden Hospital Medical Center — Castro Valley, California
• Sutter Davis Hospital — Davis, California
• Palo Alto Medical Foundation-Fremont — Fremont, California
• Loma Linda University Medical Center — Loma Linda, California
• Fremont - Rideout Cancer Center — Marysville, California
• Mercy Cancer Center — Merced, California
• Memorial Medical Center — Modesto, California
• Palo Alto Medical Foundation-Camino Division — Mountain View, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.