Non Small Cell Lung CancerPhase 3NCT04866017
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
A Phase 3 study testing Tislelizumab, Durvalumab and Ociperlimab in people with Non Small Cell Lung Cancer, run by BeiGene at 35 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Tislelizumab, Durvalumab and Ociperlimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 35 sitesin 5 countries
- Study dates
- 17 Jun 2021to 17 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
- Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
- Participants must have not experienced PD following definitive, platinum-based cCRT.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function
- Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy obtained prior to cCRT (if archival tissue is not available) for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers.
Who cannot join
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
- Participants who received systemic anticancer treatment besides the specified cCRT.
- Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone [in Japan, prednisolone] or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
Show all 9Show fewer
- Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.
- Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- NOTE: Other protocol Inclusion/Exclusion criteria may apply.
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
China20 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University Third Hospital
Beijing
Jilin Cancer Hospital
Changchun, Jilin, 130021
The First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Cancer Hospital - GCP Office
Changsha, Hunan, 410013
Changzhou Cancer Hospital
Changzhou, 213000
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310016
Jieyang People'S Hospital (Jieyang Affiliated Hospital, Sun Yat-Sen University )
Jieyang, 522091
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan, Shandong, 250117
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
Nanjing First Hospital
Nanjing, Jiangsu, 210009
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, 215006
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Australia7 sites
Townsville Hospital
Douglas, Queensland, 4814
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Gold Coast University Hospital
Gold Coast, 4215
Royal Hobart Hospital
Hobart, Tasmania
Cabrini Hospital
Malvern, Victoria, 3144
Hollywood Private Hospital
Perth
Southern Medical Day Care Centre
Wollongong, New South Wales, NSW 2500
Taiwan4 sites
Changhua Christian Hospital
Changhua, 50006
Chung Shan Medical University Hospital
Taichung, 40201
Taichung Veterans General Hospital
Taichung
Taipei Veterans General Hospital
Taipei, 11217
Spain3 sites
Hospital Universitario Fundación Jiménez Díaz
Alcorcón, Madrid, 28040
Instituto Oncologico Dr. Rosell
Barcelona, 08028
Ico Girona
Girona, 17007
United States1 site
XCancer/Centeral Care Center
Bolivar, Missouri, 65613
About this study
Official title: A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
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.
Read the detailed description
The study initiated with Protocol Amendment 1.0 (PA 1; dated on 16 April 2021). In April 2022 Protocol Amendment 2 (PA 2) was implemented. In PA 1, participants with newly diagnosed, histologically confirmed, unresectable locally advanced NSCLC and evaluable PD-L1 expression all comers were enrolled; cCRT was given within the study. In PA 2, the enrollment of the target population was revised into participants with unresectable locally advanced NSCLC whose disease has not progressed after definitive, platinum-based cCRT and with PD-L1 expression on ≥ 1% of tumor cells as assessed by the central lab; cCRT was given outside of the study.
After implementation of PA 2, participants who were randomized under PA 1 were given the option to continue assigned study treatment or to discontinue assigned treatment and begin standard of care treatment outside of the study. Participants enrolled under PA 1 were excluded from the primary and secondary analysis specified by PA 2.
This study was subsequently terminated by the Sponsor prior to enrollment of any participants under PA 2.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Tislelizumab, Durvalumab, Ociperlimab, Chemotherapy, Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
200 mg intravenously every three weeks
DurvalumabDrug
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)
OciperlimabDrug
Also called BGB-A1217
900 milligrams (mg) intravenously every three weeks
ChemotherapyDrug
Also called Concurrent Chemoradiotherapy (cCRT)
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.
RadiotherapyRadiation
Also called Concurrent Chemoradiotherapy (cCRT)
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Durvalumab; Drug: Chemotherapy; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through to the end of study, planned duration was 20 months
Secondary outcomes (15)
Overall Survival (OS)
Defined as the time from the date of randomization until the date of death due to any cause
Measured: From randomization through to the end of study, planned duration was 20 months
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.
Measured: From randomization through to the end of study, planned duration was 20 months
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
Measured: From randomization through to the end of study, planned duration was 20 months
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.
Measured: From randomization through to the end of study, planned duration was 20 months
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
Measured: From randomization through to the end of study, planned duration was 20 months
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)
Measured: 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)
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.
Measured: Baseline and Cycle 6 (Each cycle is 21 days)
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.
Measured: Baseline and Cycle 6 (Each cycle is 21 days)
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.
Measured: Baseline and Cycle 6 (Each cycle is 21 days)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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)
Measured: 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
Immunogenic Responses to Tislelizumab 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 + Tislelizumab + cCRT) and Arm B (Tislelizumab + cCRT)
Measured: 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)
Programmed Death-Ligand 1 (PD-L1) and T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Expression in Archival and/or Fresh Tumor Tissues
Measured: From randomization through to the end of study, planned duration was 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start17 Jun 2021
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Why it stopped: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866017
- Sponsor's protocol ID
- BGB-A317-A1217-301
- Other IDs
- 2020-004656-14, AdvanTIG-301
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2020
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT04866017
- Acronym / sponsor ID
- BGB-A317-A1217-301
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision was conducted by the sponsor and not driven by safety concerns as no new safety signals have been observed in the ociperlimab program.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study initiated with Protocol Amendment 1.0 (PA 1; dated on 16 April 2021). In April 2022 Protocol Amendment 2 (PA 2) was implemented. In PA 1, participants with newly diagnosed, histologically confirmed, unresectable locally advanced NSCLC and evaluable PD-L1 expression all comers were enrolled; cCRT was given within the study. In PA 2, the enrollment of the target population was revised into participants with unresectable locally advanced NSCLC whose disease has not progressed after definitive, platinum-based cCRT and with PD-L1 expression on ≥ 1% of tumor cells as assessed by the central lab; cCRT was given outside of the study.
After implementation of PA 2, participants who were randomized under PA 1 were given the option to continue assigned study treatment or to discontinue assigned treatment and begin standard of care treatment outside of the study. Participants enrolled under PA 1 were excluded from the primary and secondary analysis specified by PA 2.
This study was subsequently terminated by the Sponsor prior to enrollment of any participants under PA 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ociperlimab + Tislelizumab + cCRT | Experimental | Drug: Tislelizumab, Drug: Ociperlimab, Drug: Chemotherapy, Radiation: RadiotherapyParticipants 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 |
| Tislelizumab + cCRT | Experimental | Drug: Tislelizumab, Drug: Chemotherapy, Radiation: RadiotherapyParticipants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase |
| cCRT followed by Durvalumab | Experimental | Drug: Durvalumab, Drug: Chemotherapy, Radiation: RadiotherapyParticipants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
- Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
- Participants must have not experienced PD following definitive, platinum-based cCRT.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (9 listed)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
- Participants who received systemic anticancer treatment besides the specified cCRT.
- Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAlso: BGB-A317200 mg intravenously every three weeks | Drug | Ociperlimab + Tislelizumab + cCRT, Tislelizumab + cCRT |
| Durvalumab10 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) | Drug | cCRT followed by Durvalumab |
| OciperlimabAlso: BGB-A1217900 milligrams (mg) intravenously every three weeks | Drug | Ociperlimab + Tislelizumab + cCRT |
| ChemotherapyAlso: Concurrent Chemoradiotherapy (cCRT)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. | Drug | Ociperlimab + Tislelizumab + cCRT, Tislelizumab + cCRT, cCRT followed by Durvalumab |
| RadiotherapyAlso: Concurrent Chemoradiotherapy (cCRT)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. | Radiation | Ociperlimab + Tislelizumab + cCRT, Tislelizumab + cCRT, cCRT followed by Durvalumab |
Primary outcome
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
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.
15 secondary outcomes
Overall Survival (OS)
Time frame: From randomization through to the end of study, planned duration was 20 months
Overall Response Rate (ORR)
Time frame: From randomization through to the end of study, planned duration was 20 months
Duration of Response (DOR)
Time frame: From randomization through to the end of study, planned duration was 20 months
Time to Death or Distant Metastasis (TTDM) as Assessed by the Investigator
Time frame: From randomization through to the end of study, planned duration was 20 months
Progression-Free Survival 2 (PFS2)
Time frame: From randomization through to the end of study, planned duration was 20 months
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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)
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
Time frame: Baseline and Cycle 6 (Each cycle is 21 days)
Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
Time frame: Baseline and Cycle 6 (Each cycle is 21 days)
Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by European Quality of Life-5 Dimensions (EQ-5D-5L)
Time frame: Baseline and Cycle 6 (Each cycle is 21 days)
Serum Concentration of Ociperlimab
Time frame: 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)
Serum Concentration of Tislelizumab for Participants in the Ociperlimab + Tislelizumab + cCRT Treatment Group
Time frame: 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)
Serum Concentration of Tislelizumab for Participants in the Tislelizumab + cCRT Treatment Group
Time frame: 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)
Immunogenic Responses to Ociperlimab as Assessed by the Detection of Treatment Emergent Anti-Drug Antibodies (ADAs)
Time frame: 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
Immunogenic Responses to Tislelizumab as Assessed by the Detection of Treatment Emergent Anti-Drug Antibodies (ADAs)
Time frame: 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)
Programmed Death-Ligand 1 (PD-L1) and T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Expression in Archival and/or Fresh Tumor Tissues
Time frame: From randomization through to the end of study, planned duration was 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tislelizumab, Durvalumab and Ociperlimab in people with Non Small Cell Lung Cancer, run by BeiGene at 35 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China, Australia, Taiwan, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.