Phase 2
Completed N=272
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) · Nonsmall Cell Lung Cancer, Stage IIIB · Nonsmall Cell Lung Cancer, Stage IV
Source: ClinicalTrials.gov NCT05014815 ↗
Enrolled (actual)
272
Serious AEs
50.6%
Results posted
Sep 2025
Primary outcomePrimary: Progression-free Survival (PFS) — 8.2; 8.1 Months — p=0.4698
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
8.2; 8.1 | 0.4698 |
| SECONDARY Objective Response Rate (ORR) |
41.9; 47.8 | — |
| SECONDARY Duration of Response (DOR) |
10.4; 11.2 | — |
| SECONDARY Overall Survival (OS) |
20.6; 19.4 | — |
| SECONDARY Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
134; 135; 63; 74 | — |
Eligibility Criteria
Key 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.
Key Exclusion Criteria
- Participants were excluded if they had known mutations in any of the following genes:
- Epidermal Growth Factor Receptor (EGFR): For participants with non-squamous NSCLC and unknown EGFR mutation status, tissue-based EGFR testing (performed either locally or at a central laboratory) or an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test was required prior to enrollment. Those found to harbor EGFR-sensitizing mutations were excluded.
- Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
- B-Raf Proto-Oncogene (BRAF) V600E mutation.
- ROS Proto-Oncogene 1 (ROS1) rearrangement.
- Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
- 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.
Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
Data sourced from ClinicalTrials.gov (NCT05014815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.