Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
- Summary
- This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.
- Short title
- Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
- Official title
- AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-09-04
- First posted
- 2021-08-20
- Registry last updated
- 2025-09-16
- Primary completion date
- 2024-09-04
- Start date
- 2021-11-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- BeiGene
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05014815
- ClinicalTrials.gov ID
- NCT05014815
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Progression-free Survival (PFS)
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Objective Response Rate (ORR)
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
Objective response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Duration of Response (DOR)
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.
Overall Survival (OS)
Timeframe: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months
OS was defined as the time from randomization to the documented date of death for participants who died on or before the clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 months)
The number of participants who experienced TEAEs and SAEs was reported. An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- Participants had histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had metastatic non-squamous or squamous NSCLC.
- Participants had not received any prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapies. Those who had previously received neoadjuvant or adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease, were required to have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
- Archival tumor tissue or a fresh biopsy (if archival tissue was unavailable) was required for programmed death-ligand 1 (PD-L1) level assessment and retrospective biomarker analyses. Only participants with evaluable PD-L1 results were considered eligible.
- Participants were required to have had at least one measurable lesion as assessed by the investigator in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key Exclusion Criteria:
-
Participants were excluded if they had known mutations in any of the following genes:
- Epidermal Growth Factor Receptor (EGFR): For participants with non-squamous NSCLC and unknown EGFR mutation status, tissue-based EGFR testing (performed either locally or at a central laboratory) or an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test was required prior to enrollment. Those found to harbor EGFR-sensitizing mutations were excluded.
- Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
- B-Raf Proto-Oncogene (BRAF) V600E mutation.
- ROS Proto-Oncogene 1 (ROS1) rearrangement.
-
Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
-
Participants who had received any prior therapies targeting T-cell costimulatory or checkpoint pathways (e.g., programmed cell death protein 1 [PD-1], programmed death-ligand 1 [PD-L1], or cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]) for metastatic NSCLC were excluded.
-
Participants who had any condition requiring systemic treatment with corticosteroids at a dose greater than 10 mg of prednisone (or equivalent) daily, or other immunosuppressive medications within 14 days prior to randomization.
-
Participants who had an active infection, including but not limited to tuberculosis, requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to randomization were excluded.
Note: Additional protocol-defined inclusion and exclusion criteria may have applied.
- Valkyrie Clinical TrialsLos Angeles, United States
- University of Iowa Hospitals and ClinicsIowa City, United States
- Comprehensive Cancer Center of NevadaLas Vegas, United States
- Rj Zuckerberg Cancer CenterNew Hyde Park, United States
- North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)New York, United States
- North Shore Hematology Oncology Associates Dba New York Cancer and Blood SpecialistsPort Jefferson Station, United States
- Ny Cancer and Blood SpecialistsThe Bronx, United States
- Xcancerdayton Physician NetworkDayton, United States
- Tennessee Cancer SpecialistKnoxville, United States
- Texas Oncology Tyler LongviewAustin, United States
- Cancer Care NorthwestSpokane Valley, United States
- Border Medical OncologyEast Albury, Australia
- Northern Beaches HospitalFrenchs Forest, Australia
- Port Macquarie Base HospitalPort Macquarie, Australia
- Townsville University HospitalDouglas, Australia
- Toowoomba HospitalToowoomba, Australia
- Launceston General HospitalLaunceston, Australia
- Peninsula and South Eastern Haematology and Oncology GroupFrankston, Australia
- Olivia Newton John Cancer Wellness and Research CentreHeidelberg, Australia
- Klinik Penzing Wien, Abteilung Fur AtemwegsVienna, Austria
- Beijing Cancer HospitalBeijing, China
- Xinqiao Hospital Affiliated to the Army Medical UniversityChongqing, China
- Daping Hospital, Third Military Medical UniversityChongqing, China
- Fujian Cancer HospitalFuzhou, China
- The First Hospital of Lanzhou UniversityLanzhou, China
And 39 more, listed on the interactive page.
- 2021-001075-17
- CTR20212782