OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

Part of paid clinical trials in Burbank, California.

Sponsor
OSE Immunotherapeutics
Study ID
NCT02654587
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OSE2101 — BIOLOGICAL
  • Docetaxel — DRUG
  • Pemetrexed — DRUG

Study Details

The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment. The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)

Key Dates

Start date
Feb 12, 2016
Status verified
Jan 2024
Primary completion
Jan 15, 2021
Completion
Jan 15, 2021

Study Design

Enrollment
219 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OSE2101
    OSE2101 was administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. Should pseudo progression or delayed response to treatment suspected in arm A, investigator may continue treatment beyond the time of RECIST-defined progression, if the patient is perceived to be experiencing clinical benefit of OSE2101. OSE2101 dose was 5 mg of peptides (0.5 mg for each peptide).
  • Active Comparator: Docetaxel or Pemetrexed
    Patients receiving docetaxel: Docetaxel 75 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of a 21-day cycle. Patients receiving pemetrexed: Pemetrexed, 500 mg/m2, will be administered by intravenous infusion over 10 minutes on Day 1 of a 21-day cycle. Docetaxel and pemetrexed will be continued until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Approx. 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
East Valley Hematology and Oncology medical GroupBurbankCalifornia91505-
Georgetown University HospitalWashington D.C.District of Columbia20007-
BRCR Medical Center, IncBoca RatonFlorida33322-
Pontchartrain Cancer CenterCovingtonLouisiana70433-
Meyer Cancer Center, Weill Cornell MedecineNew YorkNew York100001-
Gabrail Cancer Center ResearchCantonOhio44718-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Robert W. Franz Cancer CenterPortlandOregon97225-
Gesinger Medical CenterDanvillePennsylvania17822-
Millenium OncologyHoustonTexas77090-

Find similar trials in Burbank, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
East Valley Hematology and Oncology medical Group· Burbank, CAGeorgetown University Hospital· Washington D.C., DCBRCR Medical Center, Inc· Boca Raton, FLPontchartrain Cancer Center· Covington, LAMeyer Cancer Center, Weill Cornell Medecine· New York, NYGabrail Cancer Center Research· Canton, OH

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