Non Small Cell Lung CancerPhase 2NCT05577702
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
A Phase 2 study testing Tislelizumab, Ociperlimab and Alcestobart in people with Non Small Cell Lung Cancer, run by BeiGene at 14 sites in China.
Trial summary
This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery. 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, Ociperlimab and Alcestobart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 14 sitesChina
- Study dates
- 8 Mar 2023to 23 Jan 2025
- Phase
- Phase 2
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
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
- Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening
Who cannot join
- Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Has mixed small cell lung cancer
- Participants with large cell neuroendocrine carcinoma (LCNEC)
- The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease
- Known epidermal growth factor receptor (EGFR) sensitizing mutations and/or anaplastic lymphoma kinase (ALK) rearrangement
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Anyang Cancer Hospital
Anyang, Henan, 455001
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hunan Cancer Hospital
Changsha, Hunan, 410013
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
Guangzhou, Guangdong, 510140
Shandong Cancer Hospital
Jinan, Shandong, 250117
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
Ningbo, Zhejiang, 315000
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
About this study
Official title: A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer
This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery.
Read the detailed description
This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA NSCLC. The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.
The study consisted of a neoadjuvant treatment phase (2 - 4 cycles of treatment), a surgery phase and a follow-up phase.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Tislelizumab, Ociperlimab, Alcestobart, Cisplatin, Carboplatin
- 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, Tevimbra
Administered as an intravenous infusion once every 3 weeks
OciperlimabDrug
Also called BGB-A1217
Administered as an intravenous infusion once every 3 weeks
AlcestobartDrug
Also called LBL-007
Administered as an intravenous infusion once every 3 weeks
CisplatinDrug
75 mg/m^2 administered as an intravenous infusion once every 3 weeks
CarboplatinDrug
Administered as an intravenous infusion once every 3 weeks at an area under the curve (AUC) of 5 mg/mL/min
PemetrexedDrug
500 mg/m^2 administered as an intravenous infusion once every 3 weeks in participants with non-squamous NSCLC
PaclitaxelDrug
175 mg/m^2 administered as an intravenous infusion once every 3 weeks in participants with squamous NSCLC
| Study group | Role | What they receive |
|---|---|---|
| Arm 1A: Tislelizumab Monotherapy | Experimental | Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. Receives: Drug: Tislelizumab |
| Arm 1B: Tislelizumab + Ociperlimab | Experimental | Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. Receives: Drug: Tislelizumab; Drug: Ociperlimab |
| Arm 1C: Alcestobart + Tislelizumab | Experimental | Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. Receives: Drug: Tislelizumab; Drug: Alcestobart |
| Arm 2A: Tislelizumab and Chemotherapy | Experimental | Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. Receives: Drug: Tislelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
| Arm 2C: Alcestobart + Tislelizumab + Chemotherapy | Experimental | Participants with tumor PD-L1 expression < 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. Receives: Drug: Tislelizumab; Drug: Alcestobart; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.
Measured: At the time of surgery, approximately Week 16
Secondary outcomes (10)
Pathological Complete Response (pCR)
Pathological complete response is defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR. Participants without surgery or pathological results were considered as non-responders.
Measured: At the time of surgery, approximately Week 16
Event-free Survival (EFS)
EFS is defined as the time from randomization until any of the following events, whichever occurred first: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. Median EFS was estimated using Kaplan-Meier methodology.
Measured: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Event-free Survival Rate
Event-free survival rate is defined as the percentage of participants with none of the following events: radiographic disease progression that precludes definitive surgery, local or distant recurrence as assessed by investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. EFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Measured: 12 months and 24 months after randomization
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Measured: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who were still alive at the analysis time points. OS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Measured: 12 months and 24 months after randomization
Disease-free Survival (DFS)
DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurred first. Median DFS was estimated using Kaplan-Meier methodology.
Measured: From randomization until the end of study, maximum time on study was 22 months in Substudy 1 and 13 months in Substudy 2.
Disease-free Survival Rate
Disease-free survival rate is defined as the percentage of participants with none of the following events: Local or distant recurrence as assessed by the investigator per RECIST v1.1, or death due to any cause. Local recurrence is defined as recurrence in the ipsilateral thorax (lymph node or lung on the same side as Baseline location) including lung parenchyma, bronchial stump, main trachea, hilum or mediastinal lymph nodes (including subcarinal lymph nodes), pleura and chest wall diagnosed by radiological examination and/or histopathological confirmation. Distant recurrence (metastasis) is defined as spread of disease beyond the area of the ipsilateral thorax (including contralateral area and other organs) diagnosed by radiological examination and/or histopathological confirmation. DFS rates were estimated using the Kaplan-Meier method with the corresponding 95% confidence interval constructed using Greenwood's formula.
Measured: 12 months and 24 months after randomization
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:
- Resulted in death
- Was life-threatening
- Required hospitalization or prolongation of existing hospitalization
- Resulted in disability/incapacity
- Was a congenital anomaly/birth defect
- Was considered a significant medical AE by the investigator or sponsor based on medical judgement (eg, may have jeopardized the participant or may require medical/surgical intervention to prevent one of the outcomes listed above).
Immune-mediated adverse events (imAEs) are autoimmune-mediated complications that may develop in response to immunotherapeutic agents. Immune-mediated AEs were collected from the date of first dose of study drug to 90 days after the last dose of study drug, regardless of whether the participant started a new anticancer therapy or prespecified adjuvant treatment. imAEs were identified by the investigator based on a standard process defined in the Protocol.
Measured: From first dose of study drug until 30 days after last dose or new anticancer treatment, whichever occurred first, or up to 90 days after the last dose for imAEs; maximum duration of treatment was 14 weeks.
Feasibility of Surgery
Feasibility of surgery was assessed by the number of participants who underwent surgical resection (surgery) within 6 weeks of last dose of study drug, had delayed or canceled surgery, the approach of surgery, duration of surgery (see next outcome measure) ,and the number of participants who underwent an exploratory thoracotomy, a surgical procedure in which a cut is made between the ribs to see and reach the lungs or other organs in the chest or thorax. Exploratory thoracotomy was not counted as surgery.
Measured: At the time of surgery, approximately Week 16
Duration of Surgery
The duration of surgery is defined as the time interval from the start of the surgical procedure to its completion.
Measured: Approximately Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start8 Mar 2023
- Primary completion13 Dec 2024
- Study completion23 Jan 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577702
- Sponsor's protocol ID
- BGB-LC-202
- Other IDs
- CTR20222760
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2022
- Last updated
- 9 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Begene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. Beigene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for Beigene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.