A Phase II Trial of Trametinib with Docetaxel in Patients with Kras Mutation Positive NSLCL and Progressive Disease Following One or Two Prior Systemic Therapies.


Contact Information
Contact Name: Oncology Research
Contact Phone: 810-762-8039 -or- 810-762-8181 Toll Free: 888-762-8675
Contact E-mail: WStrong@ghci.org

This information is intended to give a brief overview of the clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above. To obtain more details related to trial eligibility and the treatment plan, please talk to your physician or a GHCI Oncology Research Nurse at 762-8039. For more information about clinical trials, please visit the NCI cancer trials website at http://cancertrials.nci.nih.gov.

Research & Trial Information

**NOTE: The Study Will Not Pay For KRAS Testing**

Protocol#: SWOG – S1507

Cancer Type: Lung

Eligibility:

  1. Patients must have pathologically confirmed KRAS mutation (at codon 12, 13 and 61) positive NSCLC that is Stage IV or recurrent. The specific subtype of KRAS mutation must be known. KRAS mutation and subtype testing must have been performed in a CLIA certified laboratory.
  2. Patients must have measurable disease documented by CT or MRI within 28 days prior to registration.
  3. Patients must not have known brain metastases.
  4. 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 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. Patients must not have received any chemotherapy, biologic agent, or any investigational agent within 14 days prior to registration.
  6. Prior treatment with an anti-PD-1 or anti-PDL1 is not required.
  7. Patients must not have received prior docetaxel. Patients must not have received therapy with a drug known to be either a MEK inhibitor or a P13K/AKT/mTOR pathway inhibitor.
  8. Patients must have recovered from any AE’s to equal or less than a grade 1.
  9. 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.
  10. Patients must not have had a major surgery within 28 days to prior registration.
  11. Zubrod performance status 0-2.
  12. Patients must be able to swallow oral medications.
  13. Patients must not have prior history of interstitial lung disease or pneumonitis.
  14. Patients must not have a history of significant co-morbid illnesses.
  15. Patients must not have a known history of active hepatitis B or C infection.
  16. No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.