Clinical trial · Interventional
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Nonsmall Cell Lung Cancer, Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Nonsmall Cell Lung Cancer, Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Ociperlimab | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (O+T+C)
- description
- During the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
- interventionNames
- Drug: Ociperlimab
- Drug: Tislelizumab
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Nab paclitaxel
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- PLACEBO_COMPARATOR
- label
- Arm B (P+T+C)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. 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. 2. 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. 3. 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. 4. 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. 5. Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Key Exclusion Criteria: 1. 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. 2. Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations. 3. 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. 4. 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. 5. 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.
References
Publications (0)
Data not yet available