Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Verified date | May 2024 |
Source | BeiGene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
Status | Active, not recruiting |
Enrollment | 662 |
Est. completion date | October 2026 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in = 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status = 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Cancer Specialists | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
BeiGene |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | OS will be defined as the time from the date of randomization to the date of death due to any cause. | Up to approximately 58 months | |
Secondary | Progression-free Survival (PFS) As Assessed By Investigators | PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first. | Up to approximately 58 months | |
Secondary | Overall Response Rate (ORR) As Assessed By Investigators | ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1. | Up to approximately 58 months | |
Secondary | Duration Of Response (DOR) As Assessed By Investigators | DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first. | Up to approximately 58 months | |
Secondary | Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) | HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.
The EORTC QLQ-C30 (Version 3) consists of Global health status/QoL (score range from 0=very poor to 7=excellent), 5 functioning scales (physical, role, emotional, cognitive, social), 8 symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, diarrhea) and financial difficulties with scores ranging from 1 = "Not at all" to 4 = "Very much". For the global health status/QoL and functioning scales, higher scores indicate better outcomes and for symptom scales, lower scores indicate better outcomes. |
Within 7 days after permanent treatment discontinuation | |
Secondary | HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13. | QLQ-LC13 consists of 10 scales, scores ranging from 1 = "not at all" to 4 = "very much", and 2 questions regarding use of pain medication (yes/no) and if yes, did it help (1 = "not at all" to 4 = "very much"). In symptom scales, lower scores indicate better outcomes. | Within 7 days after permanent treatment discontinuation | |
Secondary | HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire | HRQoL will be assessed via PRO using the EQ-5D-5L. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analog scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 0 to 100 scale, with 100 = "the best health you can imagine" and 0 = "'the worst health you can imagine". Lower scores in descriptive dimension indicate better HRQoL and higher VAS scores indicates better health state. | Within 7 days after permanent treatment discontinuation | |
Secondary | Time To Deterioration (TTD) | TTD will be analyzed using PRO scores, and will be defined as worsening scores of =10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause. | Within 7 days after permanent treatment discontinuation | |
Secondary | Number Of Participants Experiencing Adverse Events (AEs) | The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). | 90 days (±14) after last dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |