Study of TH-302 or Placebo in Combination With Pemetrexed in Patients With Non-squamous Non-small Cell Lung Cancer
NCT ID: NCT02093962
Last Updated: 2025-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
265 participants
INTERVENTIONAL
2014-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TH-302 and pemetrexed
TH-302 in combination with pemetrexed
TH-302 combination with pemetrexed
400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
Placebo and pemetrexed
Matching placebo in combination with pemetrexed
Matched placebo in combination with pemetrexed
Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
Interventions
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TH-302 combination with pemetrexed
400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration.
Matched placebo in combination with pemetrexed
Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
ImmunoGenesis
INDUSTRY
Responsible Party
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Principal Investigators
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Tillman Pearce, MD
Role: STUDY_CHAIR
Threshold Pharmaceuticals
Jonathan Goldman, MD
Role: PRINCIPAL_INVESTIGATOR
UCLA-Dept of Medicine a Div of Hem/Onc
Locations
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UAB Cancer Center
Birmingham, Alabama, United States
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
Oncology Consultants
Houston, Texas, United States
Millennium Oncology
Houston, Texas, United States
Fpr Belvoir Community Hospital
Fort Belvoir, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Hospital Na Bulovce, Department of Pneumology and Thoracic Surgery
Libeň, , Czechia
General Univesity Hospital in Prague, Clinic of Oncology
Prague, , Czechia
Thomayer Hospital, Clinic of Pneumology
Prague, , Czechia
Regional Hospital T. Bta, Department of Pneumology
Zlín, , Czechia
Asklepios Fachkliniken Munchen-Gaunting
Gauting, Bavaria, Germany
Marien Hospital Herne
Herne, North Rhine-Westphalia, Germany
Charité Universitätsmedizin Berlin;
Berlin, , Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt, , Germany
Lungen Clinic Grosshandsdorf GmbH
Großhansdorf, , Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, , Germany
Städtisches Klinikum München - Klinikum Bogenhausen
München, , Germany
Universitätsklinikum Ulm; Zentrum für Innere Medizin
Ulm, , Germany
IASO General, Oncology Unit
Athens, , Greece
Attikon University General Hospital
Athens, , Greece
Department of Medical Oncology
Heraklion, , Greece
University General Hospital of Patras, Oncology Unit
Pátrai, , Greece
Koranyi National Institute of TBC and Pulmonology, 14th Dept of Pulmonology
Budapest, , Hungary
Koranyi National Institute of TBC and Pulmonology, 6th Department of Pulmonology
Budapest, , Hungary
Koranyi National Institute of TBC and Pulmonology, 8th Department of Pulmonology
Budapest, , Hungary
University of Debrecen, Medical and Health Science Center, Department of Pulmonology
Debrecen, , Hungary
Csongrad County Hospital of Chest Diseases
Deszk, , Hungary
Hetenyi Geza Hospital, Department of Oncology
Szolnok, , Hungary
"Mater Salutis" Hospital - Operative Unit of Oncology
Verona, Legnago, Italy
A.O.U.S. Luigi GonzagaUniversity Hospital
Orbassano, Torino, Italy
Hospital Bellaria "Carlo Alberto Pizzardi" - Operative Unit of Oncology
Bologna, , Italy
IRCCS Azienda Ospedallera Universitaria San Martino-IST-Istituto Nazionale per la Ricerca sul Cancro
Genova, , Italy
European Institute of Oncology (IEO) - Medical Care Unit
Milan, , Italy
S. Gerardo Hospital - Complex Structure of Medical Oncology
Monza, , Italy
Azienda Ospedaliera Universitaria Policlinico della Seconda Universita di Napoli
Napoli, , Italy
University Hospital of Pisa, Department of Cardothoracic Surgery, Operative unit of Pneumology
Pisa, , Italy
"Santa Maria degli Angeli" - Hospital - Complex Operative Unit of Oncology
Pordenone, , Italy
San Camillo-Forlanini Hospital - U.O.C. Pneumologia Oncologica 1
Rome, , Italy
Med-Polonia Sp. z o.o.
Poznan, , Poland
L. Rydygier Provencial Hospitals in Torun, Dept. of Tumors Chemotherapy
Torun, , Poland
Maria Sklodowska-Curie Institute of Oncology in Warsaw
Warsaw, , Poland
Oncology Centre "Sf. Nectarie"
Craiova, Dolj, Romania
Pro. Dr. Alex Trestioreanu Institute of Oncology
Bucharest, , Romania
Prof. Dr. Ioan Chiricuta Institute of Oncology
Cluj-Napoca, , Romania
Republican Clinical Oncology Center under the Ministry of Healthcare of Tatarstan Republic
Kazan', Tatarstan Republic, Russia
Russian Oncology Research Center n.a. N.N. Blokhin under the Russian Academy of Medical Sciences
Moscow, , Russia
Blokhin Russian Oncology Research Center
Moscow, , Russia
State Healthcare Institution: Nizhny Novgorod Regional Oncology Center
Nizhny Novgorod, , Russia
St. Petersburg Clinical Center for Applied Special Medical Services (Oncology)
Saint Petersburg, , Russia
St. Petersburg 1st State Medical University n.a.I.P. Pavlov under the Ministry of Healthcare of the Russian Federation
Saint Petersburg, , Russia
City Clinical Oncology Center, Oncology Department (Thoracic Oncology)
Saint Petersburg, , Russia
General University Hospital Gregorio Maranon, Dept. of Oncology
Madrid, , Spain
Jimenez Diaz Foundation
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
University Hospital Virgen de Valme
Seville, , Spain
Dr. Peset University Hospital, Dept. of Oncology
Valencia, , Spain
Hospital Universitario La Fe, Servicio de Oncologia
Valencia, , Spain
Countries
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Other Identifiers
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TH-CR-415
Identifier Type: -
Identifier Source: org_study_id
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