Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Smal… (NCT05014815) | Clinical Trial Compass
CompletedPhase 2
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
United States272 participantsStarted 2021-11-16
Plain-language summary
This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants had histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had metastatic non-squamous or squamous NSCLC.
✓. Participants had not received any prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapies. Those who had previously received neoadjuvant or adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease, were required to have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
✓. Archival tumor tissue or a fresh biopsy (if archival tissue was unavailable) was required for programmed death-ligand 1 (PD-L1) level assessment and retrospective biomarker analyses. Only participants with evaluable PD-L1 results were considered eligible.
✓. Participants were required to have had at least one measurable lesion as assessed by the investigator in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion criteria
✕. Participants were excluded if they had known mutations in any of the following genes:
✕. Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
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What they're measuring
1
Progression-free Survival (PFS)
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
. Participants who had received any prior therapies targeting T-cell costimulatory or checkpoint pathways (e.g., programmed cell death protein 1 \[PD-1\], programmed death-ligand 1 \[PD-L1\], or cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]) for metastatic NSCLC were excluded.
✕. Participants who had any condition requiring systemic treatment with corticosteroids at a dose greater than 10 mg of prednisone (or equivalent) daily, or other immunosuppressive medications within 14 days prior to randomization.
✕. Participants who had an active infection, including but not limited to tuberculosis, requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to randomization were excluded.