A Phase 2 interventional study of Ociperlimab and Tislelizumab in Limited Stage Small Cell Lung Cancer, sponsored by BeiGene. Completed at 33 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 126 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Drug: Ociperlimab · Drug: Tislelizumab · Drug: Concurrent Chemoradiotherapy
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Drug: Tislelizumab · Drug: Concurrent Chemoradiotherapy
cCRT only for 4 cycles at the investigator's discretion
Drug: Concurrent Chemoradiotherapy
Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Also known as: BGB-A1217
Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Also known as: BGB-A317
Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
Progression Free Survival (PFS)
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 years
Complete Response Rate (CR)
defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Overall Response Rate (ORR)
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Duration of Response (DOR)
defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 years
Overall Survival (OS) in the ITT Analysis Set
Defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Overall Survival (OS) in the PD-L1 Analysis Set
defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Overall Survival (OS) in the TIGIT Analysis Set
defined as the time from the date of randomization to the date of death due to any cause
Time frame: Up to approximately 2 years
Distant Metastasis-free Survival (DMFS)
defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Time frame: Up to approximately 2 years
PFS in the PD-L1 Analysis Set
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Time frame: Up to approximately 2 years
PFS in the TIGIT Analysis Set
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Time frame: Up to approximately 2 years
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03
Time frame: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Participants were enrolled in multiple study centers in China, South Korea, and the United States.
| Milestone | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Started | 41 | 42 | 43 |
| Completed | 28 | 28 | 25 |
| Not completed | 13 | 14 | 18 |
| Withdrew: Death | 12 | 13 | 14 |
| Withdrew: Withdrawal by subject | 1 | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
| Months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Progression Free Survival (PFS) | 12.6 (8.7 to NA) | 13.2 (8.5 to NA) | 9.5 (8.3 to 14.4) |
defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1
| percentage of participants | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Complete Response Rate (CR) | 7.3 (1.5 to 19.9) | 9.5 (2.7 to 22.6) | 2.3 (0.1 to 12.3) |
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
| percentage of participants | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Overall Response Rate (ORR) | 85.4 (70.8 to 94.4) | 88.1 (74.4 to 96.0) | 76.7 (61.4 to 88.2) |
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
| percentage of participants | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| PD-L1 Expression in TAP ( >=1%) | 85.7 (57.2 to 98.2) | 94.1 (71.3 to 99.9) | 76.5 (50.1 to 93.2) |
| PD-L1 Expression in TAP (<1%) | 93.8 (69.8 to 99.8) | 81.8 (48.2 to 97.7) | 86.7 (59.5 to 98.3) |
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
| percentage of participants | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| TIGIT Expression Level in IC (>=1%) | 88.9 (65.3 to 98.6) | 88.0 (68.8 to 97.5) | 93.8 (69.8 to 99.8) |
| TIGIT Expression Level in IC (<1%) | 86.7 (59.5 to 98.3) | 100.0 (59.0 to 100.0) | 68.4 (43.4 to 84.4) |
defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
| Months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Duration of Response (DOR) | 10.1 (6.0 to NA) | 11.5 (6.9 to NA) | 8.2 (5.6 to NA) |
Defined as the time from the date of randomization to the date of death due to any cause
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Overall Survival (OS) in the ITT Analysis Set | NA (NA to NA) | NA (19.8 to NA) | NA (20.0 to NA) |
defined as the time from the date of randomization to the date of death due to any cause
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| PD-L1 Expression in TAP (>=1%) | NA (12.2 to NA) | NA (17.6 to NA) | NA (16.5 to NA) |
| PD-L1 Expression in TAP (<1%) | NA (13.1 to NA) | NA (7.3 to NA) | NA (13.3 to NA) |
defined as the time from the date of randomization to the date of death due to any cause
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| TIGIT Expression Level in IC (>=1%) | NA (NA to NA) | NA (NA to NA) | NA (20.0 to NA) |
| TIGIT Expression Level in IC (<1%) | NA (12.0 to NA) | NA (17.6 to NA) | NA (13.3 to NA) |
defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Distant Metastasis-free Survival (DMFS) | 17.9 (9.7 to NA) | 15.3 (9.8 to NA) | 20.0 (8.6 to NA) |
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| PD-L1 Expression in TAP ( >=1%) | 12.6 (7.8 to NA) | 15.0 (8.5 to NA) | 11.1 (8.1 to NA) |
| PD-L1 Expression in TAP (<1%) | 10.3 (5.7 to NA) | 14.8 (4.0 to NA) | 14.4 (7.9 to NA) |
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
| months | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| TIGIT Expression Level in IC (>=1%) | 17.9 (9.5 to NA) | 14.3 (7.1 to NA) | 11.2 (8.3 to NA) |
| TIGIT Expression Level in IC (<1%) | 8.7 (5.5 to 12.6) | NA (8.3 to NA) | 14.4 (7.2 to NA) |
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03
| Participants | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| Number of Participants with at least one TEAE | 41 | 42 | 43 |
| Number of participants with at least one SAE | 25 | 20 | 12 |
Collected over All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Ociperlimab + Tislelizumab | 12/41 (29.3%) | 25/41 (61%) | 41/41 (100%) |
| Arm B: Tislelizumab | 13/42 (31%) | 20/42 (47.6%) | 42/42 (100%) |
| Arm C: Concurrent Chemoradiotherapy (cCRT) | 14/43 (32.6%) | 12/43 (27.9%) | 43/43 (100%) |
| Event | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| PneumoniaInfections and infestations | 6/41 | 3/42 | 0/43 |
| Platelet count decreasedInvestigations | 6/41 | 3/42 | 4/43 |
| Neutrophil count decreasedInvestigations | 5/41 | 5/42 | 3/43 |
| White blood cell count decreasedInvestigations | 5/41 | 2/42 | 3/43 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 4/41 | 2/42 | 1/43 |
| Radiation pneumonitisInjury, poisoning and procedural complications | 3/41 | 3/42 | 1/43 |
| Radiation oesophagitisInjury, poisoning and procedural complications | 0/41 | 3/42 | 3/43 |
| AnaemiaBlood and lymphatic system disorders | 2/41 | 0/42 | 1/43 |
| HyponatraemiaMetabolism and nutrition disorders | 2/41 | 0/42 | 1/43 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/41 | 2/42 | 0/43 |
| Event | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 37/41 | 38/42 | 38/43 |
| NauseaGastrointestinal disorders | 34/41 | 32/42 | 28/43 |
| AlopeciaSkin and subcutaneous tissue disorders | 29/41 | 33/42 | 33/43 |
| White blood cell count decreasedInvestigations | 32/41 | 31/42 | 26/43 |
| Neutrophil count decreasedInvestigations | 28/41 | 31/42 | 24/43 |
| VomitingGastrointestinal disorders | 22/41 | 29/42 | 15/43 |
| Platelet count decreasedInvestigations | 26/41 | 24/42 | 22/43 |
| Decreased appetiteMetabolism and nutrition disorders | 21/41 | 25/42 | 18/43 |
| ConstipationGastrointestinal disorders | 24/41 | 19/42 | 13/43 |
| HyponatraemiaMetabolism and nutrition disorders | 16/41 | 21/42 | 16/43 |
The Intent-To-Treat (ITT) Analysis Set includes all randomized patients.
| Age, Continuous(years) | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) | Total |
|---|---|---|---|---|
| Mean | 60.5 ± 9.50 | 59.9 ± 7.11 | 61.0 ± 9.54 | 60.5 ± 8.73 |
| Sex: Female, Male(Participants) | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) | Total |
|---|---|---|---|---|
| Female | 10 | 9 | 8 | 27 |
| Male | 31 | 33 | 35 | 99 |
| Race/Ethnicity, Customized(Participants) | Arm A: Ociperlimab + Tislelizumab | Arm B: Tislelizumab | Arm C: Concurrent Chemoradiotherapy (cCRT) | Total |
|---|---|---|---|---|
| Asian | 41 | 42 | 42 | 125 |
| White | 0 | 0 | 1 | 1 |
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