EUCTR2020-004656-14-DE进行中（未招募）1 期
A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGBA1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD L1 Selected Non- Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years on the day of signing the ICF (or the legal age of
- •consent in the jurisdiction in which the study is taking place).
- •2. Ability to provide written informed consent and to understand and
- •agree to comply with the requirements of the study and the schedule of
- •assessments.
- •3. Patient has histologically or cytologically confirmed, locally advanced,
- •unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017,
- •derived from IASLC) prior to initiation of cCRT.
- •4. Patients must have completed at least 2 cycles of platinum-based
- •chemotherapy concurrent with radiotherapy. For patients who are
- •recovering from toxicities associated with prior treatment, the first dose
- •of study treatment may be delayed by up to 42 days from the end of the
- •cCRT. It is recommended to screen the patients within 14 days after the
- •completion of cCRT.
- •a. The platinum-based chemotherapy regimen must contain cisplatin or
- •carboplatin, and may contain one of the following agents: etoposide,
- •vinblastine, vinorelbine, taxane (paclitaxel or docetaxel), or pemetrexed,
- •according to the local standard of care regimens. If a patient was
- •receiving a weekly chemotherapy regimen, platinum-based
- •chemotherapy of at least 4 weeks should be completed.
- •b. The last dose of chemotherapy must be administered no later than the
- •last dose of radiotherapy. Consolidation chemotherapy is not allowed
- •after radiotherapy; but induction chemotherapy no more than 2 cycles
- •before cCRT is allowed.
- •c. Where possible, chemotherapy regimens should be given according to
- •National Comprehensive Cancer Network (NCCN) Guidelines, European
- •Society for Medical Oncology (ESMO) Guidelines, Chinese Society of
- •Clinical Oncology (CSCO) Guidelines, Japan Lung Cancer Society (JLCS)
- •Guidelines, or other local guidelines if applicable.
- •d. Patients must have received a total dose of radiation of 60 ± 10% Gy
- •(54 to 66 Gy), as part of the CRT.
- •e. The minimum technical standard for radiotherapy is 3D conformal
- •radiotherapy (3D CRT) with CT planning. Intensity modulated
- •radiotherapy (IMRT) is recommended.
- •f. RT dose received by organs is recommended to be (the medical
- •monitor needs to be consulted to confirm eligibility for the patients who
- •received higher RT dose for the organs below):
- •Spinal cord: max dose = 48 Gy
- •Lung: V20 = 35%, mean dose = 20 Gy
- •Esophagus: mean dose = 34Gy
- •Heart: V50 = 25%, mean dose = 20 Gy
- •5. Patients must have not experienced PD following definitive, platinum
- •based cCRT.
- •6. Agree to provide archival tissue (formalin-fixed paraffin-embedded
- •block containing tumor [preferred] or approximately 6 to 15 freshly cut
- •unstained slides) or fresh biopsy obtained prior to cCRT (if archival
- •tissue is not available) for prospective central evaluation of PD-L1 levels
- •and retrospective analysis of other biomarkers. PD-L1 status will be
- •assessed centrally in either a previously obtained archival tumor tissue
- •or fresh tissue obtained from a biopsy collected prior to the first dose of
- 另有 10 项未显示
排除标准
- •1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any
- •other antibody or drugs specifically targeting T-cell co-stimulation or
- •checkpoint pathways.
- •2. Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation, ALK
- •gene translocation, ROS1 gene translocation or RET gene
- •rearrangement.
- •a. For nonsquamous and squamous NSCLC, patients with known EGFR
- •mutation status, ALK translocation, ROS1 translocation, or RET
- •rearrangement who are sensitive to available targeted inhibitor therapy
- •are excluded.
- •b. For nonsquamous NSCLC, patients with unknown EGFR mutation
- •status will be required to undergo a tissue-based EGFR test locally or at
- •a central laboratory before randomization. An additional = 6 slides are
- •required if EGFR mutation status needs to be tested in a central
- •laboratory. Patients with sensitive EGFR mutation status will be
- •excluded. Patients with unknown ALK, ROS1, or RET status may be
- •c. Patients with squamous NSCLC and unknown EGFR, ALK, ROS1, or RET
- •status will not be required to be tested before randomization.
- •3. Distant metastasis identified by imaging assessment and/or other
- •examinations after definitive, platinum-based cCRT.
- •4. Patients who received chemotherapy and radiotherapy with = 1 cycle
- •overlap for LA NSCLC.
- •5. Patients who received systemic anticancer treatment besides the
- •specified cCRT.
- •6. Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT. Patients
- •with irreversible toxicity that is not reasonably expected to be
- •exacerbated by study treatment may be included (eg, hearing loss).
- •7. Patients with any grade pneumonitis from prior cCRT.
- •8. Active autoimmune diseases or history of autoimmune diseases that
- •may relapse. Note: Patients with the following diseases are not excluded
- •and may proceed to further screening:
- •a. Controlled Type I diabetes.
- •b. Hypothyroidism (provided it is managed with hormone replacement therapy only).
- •c. Controlled celiac disease.
- •d. Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis,
- •e. Any other disease that is not expected to recur in the absence of
- •external triggering factors.
- •9. Any active malignancy = 2 years before the first dose of study
- •treatment except for the specific cancer under investigation in this study
- •and any locally recurring cancer that has been treated curatively (eg,
- •resected basal or squamous cell skin cancer, superficial bladder cancer,
- •carcinoma in situ of the cervix or breast).
- •10. Any condition that required systemic treatment with either
- •corticosteroids (> 10 mg daily of prednisone [in Japan, prednisolone] or
- •equivalent) or other immunosuppressive medication = 14 days before
- •the first dose of study treatment.
- •Note: Patients who are currently or have previously been on any of the
- •following steroid regimens are not excluded:
- •a. Adrenal replacement steroid (dose = 10 mg daily of prednisone [in
- •Japan, prednisolone] or equivalent).
- 另有 10 项未显示
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