EUCTR2019-002660-27-NL进行中（未招募）1 期
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1= 50%
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
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
- •Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
- •- Treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy (other than immunotherapies) is allowed as long as therapy was completed at least 6 months prior to the diagnosis of advanced or metastatic disease.
- •Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement status:
- •- Patients with NSCLC of pure squamous cell histology can enter screening without EGFR mutation or ALK rearrangement testing or result; however, patients with pure squamous cell histology who are known to have EGFR mutations in exons 19 or 21 or ALK rearrangements will be excluded.
- •Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS= 50%) determined by IHC using FDA approved PD-L1 IHC 22C3 PharmDx assay at a local laboratory or at a Novartis designated central laboratory.
- •- The archival samples must be most recently available FFPE block or cut tissue sections from the block. Tissue sections must NOT be older than 5 months from the time of sectioning. Archival samples obtained prior to any systemic anti-neoplastic therapy (such as adjuvant therapy) will NOT be acceptable.
- •- If local laboratory testing of PD-L1 as described above is not available, a newly obtained tumor biopsy or an archival tumor sample is required to confirm the eligibility.
- •ECOG performance status = 1
- •Have at least 1 measurable lesion by RECIST 1.1; a previously irradiated lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1. Prior treatment with a MET inhibitor or HGF-targeting therapy
- •2. Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
- •3. Have known hypersensitivity to any of the excipients of capmatinib (crospovidone, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, magnesium stearate, colloidal silicon dioxide, and various coating premixes).
- •4. History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
- •5. Have untreated symptomatic central nervous system (CNS) metastases. Subjects are eligible if CNS metastases have been adequately treated with radiotherapy or surgery and remained stable for >2 weeks after treatment. The subjects must have been off steroids 7 days prior to study treatment
- •6. Presence or history of a malignant disease, other than NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
- •7. Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e. affecting activities of daily living or requiring therapeutic intervention).
- •8. Clinically significant, uncontrolled heart diseases.
- •9. Prior palliative radiotherapy for bone lesions = 2 weeks prior to starting study treatment.
- •10. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior (2 weeks for resection of brain metastases) to starting study treatment or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are not counted as major surgery and subjects can be enrolled in the study = 1 week after the procedure.
- •11. Impairment of GI function or GI disease that may significantly alter the absorption of capmatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- •12. Concomitant medication(s) with a Known Risk of Torsades de Point” per www.qtdrugs.org that cannot be discontinued or replaced by safe alternative medication.
- •13. Receiving treatment with strong inducers of CYP3A4 that cannot be discontinued at least 1 week prior to the start of treatment with capmatinib and for the duration of the study.
- •14. Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- •15. Participation in a prior investigational study (drug or device) within 30 days prior to first dose of study treatment or within 5-half lives of the investigational product, whichever is longer, or those who are expected to receive any other investigational drug or device during the conduct of the study.
- •16. Other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase subject's risk associated with study participation, or
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