Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
CompletedPhase 2Results postedLast updated 16 September 2025
What this trial tests
Phase 2 trial testing Ociperlimab in Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) in 272 participants. Completed in 4 September 2024.
18 and older, any sex, with Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) or Nonsmall Cell Lung Cancer, Stage IIIB. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Group
Value
95% CI
Arm A (O+T+C)
8.2
6.2 – 10.6
Arm B (P+T+C)
8.1
6.0 – 10.2
Objective Response Rate (ORR)Secondary· From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments.
CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Arm A (O+T+C)
41.9
33.5 – 50.7
Arm B (P+T+C)
47.8
39.2 – 56.5
Duration of Response (DOR)Secondary· From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.
Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.
Group
Value
95% CI
Arm A (O+T+C)
10.4
8.0 – 17.7
Arm B (P+T+C)
11.2
8.1 – 13.9
Overall Survival (OS)Secondary· From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
Group
Value
95% CI
Arm A (O+T+C)
20.6
14.4 – NA
Arm B (P+T+C)
19.4
15.4 – 23.1
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Secondary· From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)
The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.
Number of participants with any TEAEs
Group
Value
95% CI
Arm A (O+T+C)
134
Arm B (P+T+C)
135
Number of participants with SAEs
Group
Value
95% CI
Arm A (O+T+C)
63
Arm B (P+T+C)
74
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from randomization up to study completion date cut-off date of 04 September 2024, up to 33 months. AEs are reported from first dose of study drug to 30 days after last dose, up to study completion date of 04 September 2024, up to 32.4 months..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05809895 — Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as Fi
· Phase 2
· withdrawn
NCT05791097 — Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as
· Phase 3
· withdrawn
NCT05577702 — Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combina
· Phase 2
· completed
NCT05267054 — Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tisle
· Phase 1, PHASE2
· completed
NCT04948697 — A Study Investigating the Efficacy and Safety of Ociperlimab and Tislelizumab and BAT1706 Combinations in Patients With
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05014815.