A Study to Compare Ociperlimab Plus Tislelizumab Versus D... | NCT04866017

ID	Type	Description	Link
2020-004656-14	EudraCT Number
AdvanTIG-301	Other Identifier	BeiGene

Label	Type	Description	Intervention Names
Ociperlimab + Tislelizumab + cCRT	Experimental	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	Drug: Tislelizumab Drug: Ociperlimab Drug: Chemotherapy Radiation: Radiotherapy
Tislelizumab + cCRT	Experimental	Participants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase	Drug: Tislelizumab Drug: Chemotherapy Radiation: Radiotherapy
cCRT followed by Durvalumab	Experimental	Participants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase	Drug: Durvalumab Drug: Chemotherapy Radiation: Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
Tislelizumab	Drug	200 mg intravenously every three weeks	Ociperlimab + Tislelizumab + cCRT Tislelizumab + cCRT

Measure	Description	Time Frame
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	PFS is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death, whichever occurred first.	From randomization through to the end of study, planned duration was 20 months

Measure	Description	Time Frame
Overall Survival (OS)	Defined as the time from the date of randomization until the date of death due to any cause	From randomization through to the end of study, planned duration was 20 months
Overall Response Rate (ORR)

Facility	Status	City	State	ZIP	Country	Contacts
XCancer/Centeral Care Center		Bolivar	Missouri	65613	United States
Southern Medical Day Care Centre

ID	Title	Description
FG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 21, 2022	Oct 9, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

PFS is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death, whichever occurred first.

The primary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.
OG002	cCRT Followed by Durvalumab	Participants in PA 1 received two cycles of concurrent chemoradiotherapy (cCRT), followed by durvalumab (10 mg/kg intravenously every 2 weeks, or 1500 mg every 4 weeks if locally approved). The chemotherapy regimen was chosen by the investigator and included options such as cisplatin with etoposide, carboplatin with paclitaxel, or pemetrexed with a platinum agent for non-squamous histology; alongside radiotherapy. After cCRT, participants continued durvalumab treatment for up to one year.

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Overall Survival (OS)

Defined as the time from the date of randomization until the date of death due to any cause

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Overall Response Rate (ORR)

Defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) assessed by both the IRC and investigators per RECIST v1.1.

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Duration of Response (DOR)

defined as the time from the first determination of a confirmed objective response assessed by both the IRC and investigators per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Time to Death or Distant Metastasis (TTDM) as Assessed by the Investigator

defined as the time from the date of randomization until the first date of distant metastasis assessed by both the IRC and investigators, or death. Distant metastasis is defined as any new lesion that is outside of the radiation field per RECIST v1.1 or proven by biopsy.

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Progression-Free Survival 2 (PFS2)

defined as the time from randomization to the disease progression after next line of treatment, or death from any cause, whichever occurs first

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Number of Participants Experiencing Adverse Events (AEs)

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)

The Safety Analysis Set included all randomized patients who received any dose of study treatment.

Posted

Count of Participants

Participants

From first dose to 30 days after the last dose or initiation of a new anticancer therapy, whichever occured first; through study completion data cut-off date of October 17th, 2023 (maximum time on treatment was 16 months)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

Baseline and Cycle 6 (Each cycle is 21 days)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

Change from baseline in QLQ-CL13 scores for coughing, dyspnea, and chest pain. The QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

Baseline and Cycle 6 (Each cycle is 21 days)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Secondary

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by European Quality of Life-5 Dimensions (EQ-5D-5L)

The EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

Baseline and Cycle 6 (Each cycle is 21 days)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT

Secondary

Serum Concentration of Ociperlimab

Serum concentrations of ociperlimab were measured for participants in the Ociperlimab + Tislelizumab + cCRT treatment group at predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). End of Treatment (EOT) visits occurred within 7 days after the date the investigator determined that study treatment would no longer be used, or before the initiation of a new anticancer treatment, whichever occurred first.

The Pharmacokinetics (PK) Analysis Set includes all patients who receive any dose of any component of study drugs and for whom any postdose PK data are available.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/ml

Predose at Day 1 of Cycles 1, 2, 5, 9, and 17; postdose on Day 1 of Cycles 1, 5 and EOT visit (Each Cycle was 21 days)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT: Predose	Ociperlimab: 900 milligrams (mg) intravenously every three weeks. Predose was collected within 60 minutes before starting on Day 1 of Cycles 1, 2, 5, 9, and 17.
OG001	Ociperlimab + Tislelizumab + cCRT: Postdose	Ociperlimab: 900 milligrams (mg) intravenously every three weeks. Postdose was collected within 30 minutes after end on infusion on Day 1 of Cycles 1 and 5, and at the EOT visit.

Secondary

Serum Concentration of Tislelizumab for Participants in the Ociperlimab + Tislelizumab + cCRT Treatment Group

Serum concentrations of tislelizumab were collected for participants in the Ociperlimab + Tislelizumab + cCRT treatment group at predose (within 60 minutes before starting infusion) and postdose (within 30 minutes after the end of infusion). End of Treatment (EOT) visits occurred within 7 days after the date investigator determined that study treatment would no longer be used, or before the initiation of a new anticancer treatment, whichever occurred first.

PK Analysis Set

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Predose at Day 1 of Cycles 1, 2, 5, 9, 17; postdose on Day 1 of Cycles 1 and 5, and EOT visit (each cycle was 21 days)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT: Predose	Tislelizumab 200 milligrams (mg) intravenously every three weeks. Predose was collected within 60 minutes before starting on Day 1 of Cycles 1, 2, 5, 9, and 17.
OG001	Ociperlimab + Tislelizumab + cCRT: Postdose	Tislelizumab 200 milligrams (mg) intravenously every three weeks. Postdose was collected within 30 minutes after end on infusion on Day 1 of Cycles 1 and 5, and EOT visit.

Secondary

Serum Concentration of Tislelizumab for Participants in the Tislelizumab + cCRT Treatment Group

Serum concentrations of tislelizumab were collected for participants in the Tislelizumab + cCRT treatment group at predose (within 60 minutes prior to infusion initiation) and postdose (within 30 minutes after the completion of infusion). End of Treatment (EOT) visits occurred within 7 days after the date investigator determined that study treatment would no longer be used, or before the initiation of a new anticancer treatment, whichever occurred first.

PK Analysis Set; Tislelizumab concentration data are reported here for participants in the Tislelizumab + cCRT treatment group. Only participants with available data are included at each time point.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

Predose at Day 1 of Cycles 1, 2, 5, 9, and 17; postdose on Day 1 of Cycles 1 and 5, and EOT visit (Each Cycle is 21 days)

ID	Title	Description
OG000	Tislelizumab: Predose	Tislelizumab 200 milligrams (mg) intravenously every three weeks. Predose was collected within 60 minutes before starting on Day 1 of Cycles 1, 2, 5, 9, 17, and EOT visit.
OG001	Tislelizumab: Postdose	Tislelizumab 200 milligrams (mg) intravenously every three weeks. Postdose was collected within 30 minutes after end on infusion on Day 1 of Cycles 1 and 5

Secondary

Immunogenic Responses to Ociperlimab as Assessed by the Detection of Treatment Emergent Anti-Drug Antibodies (ADAs)

Defined as the sum of treatment-boosted and treatment-induced ADA participants as a proportion percentage of the ADA-evaluable participants population and is synonymous with 'ADA Incidence'. ADA samples were collected for participants randomized to Arm A (ociperlimab and tislelizumab)

The Immunogenicity Analysis Set includes all participants who received any dose of any component of study drugs and for whom both baseline antidrug antibody (ADA) and at least 1 postbaseline ADA result were available.

Posted

Count of Participants

Participants

Predose (within 60 minutes before dose) on Day 1 of Cycles 1, 2, 5, 9, 17, and the EOT Visit (Each cycle is 21 days). Maximum number of treatment cycles was 19

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.

Units	Counts

Secondary

Immunogenic Responses to Tislelizumab as Assessed by the Detection of Treatment Emergent Anti-Drug Antibodies (ADAs)

Posted

Count of Participants

Participants

Predose (within 60 minutes before dose) on Day 1 of Cycles 1, 2, 5, 9, 17, and the EOT Visit (Each cycle is 21 days, maximum number of treatment cycles was 19)

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT

Secondary

Programmed Death-Ligand 1 (PD-L1) and T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Expression in Archival and/or Fresh Tumor Tissues

This secondary endpoint was specified in PA 2 and excludes participants enrolled under PA 1. No participants were enrolled under PA 2.

Posted

From randomization through to the end of study, planned duration was 20 months

ID	Title	Description
OG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
OG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG00014 events12 affected22 at risk EG00115 events10 affected18 at risk EG00220 events14 affected22 at risk
Hypercoagulation	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events1 affected22 at risk
Hyperfibrinogenaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Leukocytosis	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Leukopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0004 events2 affected22 at risk EG0017 events2 affected18 at risk EG0029 events4 affected22 at risk
Lymphopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events2 affected22 at risk
Neutropenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0004 events3 affected22 at risk EG0013 events1 affected18 at risk EG0021 events1 affected22 at risk
Thrombocytopenia	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Thrombocytosis	Blood and lymphatic system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Atrial fibrillation	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Bundle branch block left	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Bundle branch block right	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Pericardial effusion	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Sinus bradycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0003 events1 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Sinus tachycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected18 at risk EG0021 events1 affected22 at risk
Supraventricular extrasystoles	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected18 at risk EG0022 events2 affected22 at risk
Tachycardia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Ventricular arrhythmia	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Ventricular extrasystoles	Cardiac disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Tinnitus	Ear and labyrinth disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Hyperthyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Hypothyroidism	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected18 at risk EG0024 events4 affected22 at risk
Thyroid mass	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Thyroiditis	Endocrine disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Abdominal distension	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Abdominal pain	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Abdominal pain upper	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Colitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Constipation	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG00012 events9 affected22 at risk EG0019 events5 affected18 at risk EG00210 events8 affected22 at risk
Diarrhoea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0014 events4 affected18 at risk EG0027 events5 affected22 at risk
Dry mouth	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Dyspepsia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Dysphagia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0010 events0 affected18 at risk EG0022 events2 affected22 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0015 events5 affected18 at risk EG0020 events0 affected22 at risk
Gingival swelling	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Haemorrhoids	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Nausea	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0007 events6 affected22 at risk EG0018 events7 affected18 at risk EG00218 events11 affected22 at risk
Odynophagia	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Oesophagitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0014 events4 affected18 at risk EG0024 events4 affected22 at risk
Paraesthesia oral	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0023 events1 affected22 at risk
Stomatitis	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Toothache	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0024 events3 affected22 at risk
Vomiting	Gastrointestinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0011 events1 affected18 at risk EG0025 events4 affected22 at risk
Asthenia	General disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0011 events1 affected18 at risk EG0025 events5 affected22 at risk
Chest discomfort	General disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0011 events1 affected18 at risk EG0022 events1 affected22 at risk
Chills	General disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Face oedema	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Facial pain	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Fatigue	General disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected22 at risk EG0015 events4 affected18 at risk EG0022 events2 affected22 at risk
Influenza like illness	General disorders	meddra 26.0	Systematic Assessment	EG0004 events2 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Malaise	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Non-cardiac chest pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Oedema peripheral	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0024 events3 affected22 at risk
Pain	General disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Puncture site pain	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Pyrexia	General disorders	meddra 26.0	Systematic Assessment	EG0005 events3 affected22 at risk EG0017 events4 affected18 at risk EG0020 events0 affected22 at risk
Swelling face	General disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Hepatic steatosis	Hepatobiliary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Contrast media allergy	Immune system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Drug hypersensitivity	Immune system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected18 at risk EG0020 events0 affected22 at risk
Hypersensitivity	Immune system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Infusion related hypersensitivity reaction	Immune system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Body tinea	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected18 at risk EG0024 events4 affected22 at risk
COVID-19 pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events2 affected22 at risk
Diarrhoea infectious	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
External ear cellulitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Folliculitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Lower respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Nasopharyngitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected18 at risk EG0024 events2 affected22 at risk
Oral fungal infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Pharyngitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Pneumonia	Infections and infestations	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0015 events4 affected18 at risk EG0021 events1 affected22 at risk
Pneumonia pseudomonal	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0023 events3 affected22 at risk
Sinusitis	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Suspected COVID-19	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Upper respiratory tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0015 events4 affected18 at risk EG0022 events2 affected22 at risk
Urinary tract infection	Infections and infestations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected18 at risk EG0020 events0 affected22 at risk
Clavicle fracture	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Contusion	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Fall	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Infusion related reaction	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0023 events1 affected22 at risk
Radiation fibrosis	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0006 events6 affected22 at risk EG0013 events3 affected18 at risk EG00210 events9 affected22 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected18 at risk EG0027 events5 affected22 at risk
Radiation skin injury	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0015 events5 affected18 at risk EG0021 events1 affected22 at risk
Skin abrasion	Injury, poisoning and procedural complications	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Alanine aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00015 events8 affected22 at risk EG0010 events0 affected18 at risk EG0029 events6 affected22 at risk
Amylase increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Aspartate aminotransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG00010 events6 affected22 at risk EG0010 events0 affected18 at risk EG0025 events4 affected22 at risk
Bilirubin conjugated increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events2 affected18 at risk EG0020 events0 affected22 at risk
Blood alkaline phosphatase increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Blood bilirubin increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events2 affected22 at risk EG0013 events2 affected18 at risk EG0021 events1 affected22 at risk
Blood bilirubin unconjugated increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected18 at risk EG0020 events0 affected22 at risk
Blood chloride decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0014 events1 affected18 at risk EG0020 events0 affected22 at risk
Blood creatine phosphokinase MB increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events1 affected22 at risk
Blood creatine phosphokinase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0014 events1 affected18 at risk EG0021 events1 affected22 at risk
Blood creatinine decreased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Blood creatinine increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events2 affected22 at risk EG0012 events1 affected18 at risk EG0023 events2 affected22 at risk
Blood fibrinogen increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Blood lactate dehydrogenase increased	Investigations	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0012 events1 affected18 at risk EG0023 events1 affected22 at risk
Blood thyroid stimulating hormone decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Blood thyroid stimulating hormone increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Blood urea increased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events1 affected22 at risk EG0014 events2 affected18 at risk EG0020 events0 affected22 at risk
Ejection fraction decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Electrocardiogram QT prolonged	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Fibrin D dimer increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected18 at risk EG0022 events1 affected22 at risk
Gamma-glutamyltransferase increased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events2 affected22 at risk EG0017 events3 affected18 at risk EG0022 events2 affected22 at risk
Haemoglobin decreased	Investigations	meddra 26.0	Systematic Assessment	EG0003 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Lymphocyte count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0007 events5 affected22 at risk EG0015 events5 affected18 at risk EG00210 events6 affected22 at risk
Myoglobin blood increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Neutrophil count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00031 events14 affected22 at risk EG00113 events5 affected18 at risk EG00229 events13 affected22 at risk
Neutrophil count increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Occult blood positive	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Platelet count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00012 events8 affected22 at risk EG0016 events5 affected18 at risk EG00216 events10 affected22 at risk
Platelet count increased	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Protein total decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0012 events1 affected18 at risk EG0020 events0 affected22 at risk
Red blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
SARS-CoV-2 test positive	Investigations	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events2 affected18 at risk EG0024 events4 affected22 at risk
Troponin T increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Weight decreased	Investigations	meddra 26.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0012 events2 affected18 at risk EG0024 events4 affected22 at risk
Weight increased	Investigations	meddra 26.0	Systematic Assessment	EG0006 events3 affected22 at risk EG0011 events1 affected18 at risk EG0023 events3 affected22 at risk
White blood cell count decreased	Investigations	meddra 26.0	Systematic Assessment	EG00045 events15 affected22 at risk EG00125 events10 affected18 at risk EG00241 events13 affected22 at risk
White blood cell count increased	Investigations	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Decreased appetite	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0008 events7 affected22 at risk EG0017 events5 affected18 at risk EG0029 events7 affected22 at risk
Dehydration	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Folate deficiency	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events1 affected18 at risk EG0021 events1 affected22 at risk
Hyperglycaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG00014 events5 affected22 at risk EG0011 events1 affected18 at risk EG0028 events4 affected22 at risk
Hyperkalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0003 events1 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events2 affected22 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0015 events1 affected18 at risk EG0023 events2 affected22 at risk
Hyperuricaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0007 events3 affected22 at risk EG0016 events4 affected18 at risk EG0028 events3 affected22 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected22 at risk EG0019 events6 affected18 at risk EG00211 events7 affected22 at risk
Hypocalcaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0004 events1 affected22 at risk EG0011 events1 affected18 at risk EG0023 events3 affected22 at risk
Hypochloraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Hypokalaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events3 affected18 at risk EG0025 events4 affected22 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Hyponatraemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0006 events5 affected22 at risk EG00113 events5 affected18 at risk EG00211 events6 affected22 at risk
Hypophosphataemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0022 events1 affected22 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0012 events2 affected18 at risk EG0025 events3 affected22 at risk
Back pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events3 affected18 at risk EG0024 events2 affected22 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events1 affected22 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0023 events2 affected22 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0022 events2 affected22 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Disturbance in attention	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Dizziness	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected18 at risk EG0026 events3 affected22 at risk
Dysgeusia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Headache	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Hypoaesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Paraesthesia	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Peripheral sensory neuropathy	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Seizure	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Somnolence	Nervous system disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Depression	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Insomnia	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0004 events3 affected22 at risk EG0013 events3 affected18 at risk EG0021 events1 affected22 at risk
Tic	Psychiatric disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Renal cyst	Renal and urinary disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected22 at risk EG0016 events5 affected18 at risk EG0026 events5 affected22 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0004 events4 affected22 at risk EG0012 events2 affected18 at risk EG0022 events2 affected22 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0013 events3 affected18 at risk EG0024 events2 affected22 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0004 events3 affected22 at risk EG0014 events2 affected18 at risk EG0024 events3 affected22 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0012 events2 affected18 at risk EG0023 events3 affected22 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Pleural thickening	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0002 events2 affected22 at risk EG0012 events1 affected18 at risk EG0022 events2 affected22 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events2 affected18 at risk EG0022 events2 affected22 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0021 events1 affected22 at risk
Alopecia	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0015 events4 affected18 at risk EG0027 events7 affected22 at risk
Angioedema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0022 events2 affected22 at risk
Dry skin	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Eczema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Erythema	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Night sweats	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Pain of skin	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Papule	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk
Pruritus	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0013 events2 affected18 at risk EG0022 events2 affected22 at risk
Psoriasis	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Rash	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0005 events4 affected22 at risk EG0012 events2 affected18 at risk EG0022 events2 affected22 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Skin fissures	Skin and subcutaneous tissue disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Aortic arteriosclerosis	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Flushing	Vascular disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Haematoma	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Hypertension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0003 events3 affected22 at risk EG0012 events1 affected18 at risk EG0022 events2 affected22 at risk
Hypotension	Vascular disorders	meddra 26.0	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected18 at risk EG0020 events0 affected22 at risk
Phlebitis	Vascular disorders	meddra 26.0	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected18 at risk EG0021 events1 affected22 at risk
Venous thrombosis limb	Vascular disorders	meddra 26.0	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected18 at risk EG0020 events0 affected22 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C000707970	tislelizumab
C000613593	durvalumab
D004358	Drug Therapy
D059248	Chemoradiotherapy
D011878	Radiotherapy

ID	Term
D013812	Therapeutics
D003131	Combined Modality Therapy

ID	Title	Description
BG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.
BG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.
BG002	cCRT Followed by Durvalumab	Participants in PA 1 received two cycles of concurrent chemoradiotherapy (cCRT), followed by durvalumab (10 mg/kg intravenously every 2 weeks, or 1500 mg every 4 weeks if locally approved). The chemotherapy regimen was chosen by the investigator and included options such as cisplatin with etoposide, carboplatin with paclitaxel, or pemetrexed with a platinum agent for non-squamous histology; alongside radiotherapy. After cCRT, participants continued durvalumab treatment for up to one year.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ociperlimab + Tislelizumab + cCRT	Participants enrolled in PA 1 received two cycles of ociperlimab (900 mg) and tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). Chemotherapy regimens varied based on investigator discretion, including options such as cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. After the cCRT phase, participants continued ociperlimab and tislelizumab treatment for up to one year.	8	22	11	22	22	22
EG001	Tislelizumab + cCRT	Participants in PA 1 received two cycles of tislelizumab (200 mg) intravenously every three weeks, combined with concurrent chemoradiotherapy (cCRT). The chemotherapy regimen was determined by the investigator and included options like cisplatin with etoposide, carboplatin with paclitaxel, or platinum-based regimens with pemetrexed for non-squamous histology; alongside radiotherapy. Following the cCRT phase, participants continued tislelizumab treatment for up to one year.	4	18	8	18	18	18
EG002	cCRT Followed by Durvalumab	Participants in PA 1 received two cycles of concurrent chemoradiotherapy (cCRT), followed by durvalumab (10 mg/kg intravenously every 2 weeks, or 1500 mg every 4 weeks if locally approved). The chemotherapy regimen was chosen by the investigator and included options such as cisplatin with etoposide, carboplatin with paclitaxel, or pemetrexed with a platinum agent for non-squamous histology; alongside radiotherapy. After cCRT, participants continued durvalumab treatment for up to one year.	8	22	8	22	22	22