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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02093962

Run by

ImmunoGenesis

People needed

265

Starts

2014-06-01

Expected to finish

2016-05-01

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ironwood Cancer and Research Centers — Chandler, Arizona, United States
• California Cancer Center — Encinitas, California, United States
• California Cancer Center Associates — Fresno, California, United States
• UCLA-Department of Medicine a Division of Hem/Onc — Los Angeles, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• VA Eastern Colorado Healthcare System — Denver, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Cancer Specialists of North Florida - CBO — Jacksonville Beach, Florida, United States
• AMPM Research — Miami, Florida, United States
• Research Medical Center — Kansas City, Kansas, United States
• Ochsner Clinical Foundation — New Orleans, Louisiana, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• St. Joseph Mercy Ann Arbor Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Clinical Research Alliance — New York, New York, United States
• Montefire-Einstein Center for Cancer Care — The Bronx, New York, United States
• Durham VA Medical Center — Durham, North Carolina, United States
• W.G. (Bill) Hefner VA Medical Center — Salisbury, North Carolina, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• DORN VA Medical Center — Columbia, South Carolina, United States
• Regional Cancer Care Institute at Regional Health — Rapid City, South Dakota, United States
• Associates in Oncology & Hematology — Chattanooga, Tennessee, United States
• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States
• UAB Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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