Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer

Overview

About this study

The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Men and women ≥ 18 years of age.
  • Histologically or cytologically confirmed stage IIIB or IV NSCLC with non-squamous histology
  • Recurrent or progressive disease after one prior platinum-based non-pemetrexed chemotherapy treatment for advanced disease with or without maintenance
  • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated < 12 months prior to study randomization will be counted as one prior treatment
  • Neoadjuvant/adjuvant cytotoxic chemotherapy initiated ≥ 12 months prior to study randomization will not be counted as one prior chemotherapy treatment
  • Use of targeted agents (e.g., monoclonal antibodies or kinase inhibitors) will not be counted as a prior chemotherapy treatment
  • Patients with known EGFR-activating mutations or ALK rearrangements should have received treatment with a targeted kinase inhibitor (e.g., erlotinib, crizotinib) and no longer be considered as a candidate for such treatment
  • Measurable disease according to RECIST 1.1
  • ECOG performance status 0-1
  • Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior therapy
  • Adequate hematologic, hepatic, cardiac, and renal function
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test, whichever is considered standard by the institution

Exclusion Criteria:

  • Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS
  • Prior therapy with pemetrexed
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation or corticosteroids
  • Inability to discontinue non-steroidal anti-inflammatory drugs for 5 days (long half-life) or for 2 days (short half-life, if CrCL <80 mL/min) before pemetrexed dosing and until 2 days after pemetrexed dosing
  • Leptomeningeal disease or any untreated or symptomatic brain metastases, unless the following criteria are met:

    • brain metastases are stable and have been previously treated with either whole-brain radiotherapy or gamma-knife surgery
    • steroids are currently not required and more than 14 days since last steroid treatment
  • Symptomatic pleural effusion (> CTCAE Grade 1 dyspnea) that is not amenable to drainage
  • Treatment with other systemic anticancer therapy within 4 weeks prior to the first dose of study medication
  • Treatment with full field radiation therapy within 4 weeks or limited field radiation therapy within 2 weeks prior to the first dose of study medication
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior the first dose of study medication
  • Elective or a planned major surgery while on study treatment
  • Radiation therapy to greater than 25% of the bone marrow
  • Clinically significant active infection (e.g. tuberculosis, viral hepatitis, HIV)
  • Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
  • Concurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
  • Pregnant or breast feeding
  • Patients who are taking medications that prolong QT interval and have a risk of Torsades de Pointes (Appendix F) or who have a history of long QT syndrome
  • Patients who are taking medications that are strong inducers or inhibitors of CYP3A4

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Julian Molina, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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