A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer

Part of paid clinical trials in Bolivar, Missouri.

Sponsor
BeiGene
Study ID
NCT04866017
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Tislelizumab — DRUG
    200 mg intravenously every three weeks
  • Durvalumab — DRUG
    10 milligrams per kilogram (mg/kg) intravenously once every 2 weeks (or 1500 mg intravenously once every 4 weeks where the dosage has been approved by a local health authority)
  • Ociperlimab — DRUG
    900 milligrams (mg) intravenously every three weeks
  • Chemotherapy — DRUG
    The chemotherapy regimen for the study treatment was selected at the investigator's discretion and may include one of the following options: * Cisplatin (50 mg/m²) on days 1 to 5 of each cycle, combined with etoposide (50 mg/m²) on days 1 and 8, both administered intravenously for 2 cycles. Each cycle was 28 days. * Carboplatin (AUC 2) weekly for 6 weeks, combined with paclitaxel (40-50 mg/m²) weekly for 6 weeks, both administered intravenously. * Cisplatin (75 mg/m²) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days. * Carboplatin (AUC 5) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days. The pemetrexed plus platinum regimen was only for participants with non-squamous histology.
  • Radiotherapy — RADIATION
    All participants recieved radiotherapy using either a standardized 3-dimensional conformal radiotherapy technique, or intensity modulated radiotherapy (IMRT) on a linear accelerator delivering a beam energy of ≥ 6 MV. The total dose of radiotherapy was 60 Gy, administered in 30 once-daily fractions of 2 Gy and 5 fractions per week for 6 weeks.

Study Details

The purpose of this study was to evaluate the safety and efficacy of ociperlimab in combination with tislelizumab compared to durvalumab in adults with stage III unresectable PD-L1-selected non-small cell lung cancer whose disease has not progressed after cCRT.

Key Dates

Start date
Jun 17, 2021
Status verified
Oct 2024
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023

Study Design

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

Arms

  • Experimental: Ociperlimab + Tislelizumab + cCRT
    Participants enrolled under PA1 recieved two cycles of ociperlimab combined with tislelizumab and cCRT, followed by ociperlimab combined with tislelizumab up to 1 year after the cCRT phase
  • Experimental: Tislelizumab + cCRT
    Participants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase
  • Experimental: cCRT followed by Durvalumab
    Participants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC) [ Time Frame: From randomization through to the end of study, planned duration was 20 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
XCancer/Centeral Care CenterBolivarMissouri65613-

Find similar trials in Bolivar, MO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
XCancer/Centeral Care Center· Bolivar, MO

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