This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen. TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
222
TG4010 • TG4010 will be administered starting on Day 1 (D1) of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by subcutaneous (SC) injections and then once every 3 weeks until progression or discontinuation due to any reason. Chemotherapy (and bevacizumab if prescribed), will be given as 21-day cycles for a minimum of 4 cycles and up to 6 cycles. First line therapy: * Non-squamous carcinoma: pemetrexed + cisplatin or paclitaxel + carboplatin +/- bevacizumab * Squamous carcinoma: gemcitabine + cisplatin or paclitaxel + carboplatin Maintenance therapy: • Pemetrexed or erlotinib for eligible patients and according to labeling.
Placebo will be administered starting on D1 of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by SC injections and then once every 3 weeks until progression or discontinuation due to any reason. * First line therapy: as in Arm 1 * Maintenance therapy: as in Arm 1
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Cambridge, Maryland, United States
Oncology/Hematology P.C.
Rockville, Maryland, United States
Phase 2: Progression-free Survival (PFS)
PFS is measured from date of randomization to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
Time frame: Approximately 15 months
Phase 3: Overall Survival (OS)
OS is measured from date of randomization to date of death from any cause.
Time frame: Approximately 27 months
Phase 2 : Overall Survival (OS)
Time frame: Approximately 15 months
Phase 2 : Overall Response Rate (ORR)
Time frame: Approximately 15 months
Phase 3: Progression-free Survival (PFS)
Time frame: Approximately 27 months
Phase 3 : Overall Response Rate (ORR)
Time frame: Approximately 27 months
Phase 2 : Duration of response
Time frame: Approximately 15 months
Phase 2: Safety
Time frame: Approximately 15 months
Phase 3: Duration of response
Time frame: Approximately 27 months
Phase 3: Safety
Time frame: Approximately 27 months
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Washington University
St Louis, Missouri, United States
Highlands Oncology Group
Fayetteville, North Carolina, United States
Signal Point Clinical Research Center
Middletown, Ohio, United States
ProMedica Health System Inc
Toledo, Ohio, United States
Abington Hematology Oncology Associates Inc
Willow Grove, Pennsylvania, United States
...and 62 more locations