NL-OMON53740尚未招募不适用
A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCER - not available
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18 years Body weight >=30 kg Whole-body positron emission
- •tomography/computed tomography scan (PET/CT) performed prior and within 42 days
- •of the first dose of cCRT or sCRT Histologically or cytologically documented
- •locally advanced, unresectable Stage III NSCLC of either squamous or
- •non-squamous histology (Version 8, American Joint Committee on Cancer/Union for
- •International Cancer Control NSCLC staging system (Amin et al. 2017). Prior
- •receipt of at least two prior cycles of platinum-based chemotherapy given
- •concurrently with radiotherapy (cCRT); or at least two prior cycles of
- •platinum-based chemotherapy given prior to radiotherapy (sCRT) The RT component
- •in the cCRT or sCRT must have been at a total dose of radiation of 60 (± 10%)
- •Gy (54 Gy to 66 Gy) administered by intensity-modulated radiotherapy
- •(preferred) or three dimension (3D)-conforming technique No disease progression
- •during or following platinum-based cCRT or sCRT Life expectancy >= 12 weeks
- •Documented tumor PD-L1 status Eastern Cooperative Oncology Group Performance
- •Status of 0, 1, or 2 • Adequate hematologic and end-organ function • For women
- •of childbearing potential: agreement to remain abstinent (refrain from
- •heterosexual intercourse) or use contraception, and agreement to refrain from
- •donating eggs, during the treatment period and for at least 90 days after the
- •final dose of alectinib or durvalumab (Cohort A1 only) Confirmed availability
- •of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen
- •Documented ALK fusion positivity (Cohort A1 only)
排除标准
- •Any history of previous NSCLC and/or any history of prior treatment for NSCLC
- •Any evidence of Stage IV disease If pleural effusion is present the following
- •criteria must be met to exclude malignant involvement (T4 disease): When
- •pleural fluid is visible on both the computed tomography scan and chest X-ray,
- •a pleuracentesis is required to confirm that the pleural fluid is cytologically
- •negative. Patients with exudative pleural effusions are excluded regardless of
- •cytology. Patients with effusions that are minimal (i.e., not visible on chest
- •X-ray) that are too small to safely tap are eligible NSCLC known to have one or
- •more of the following ALK point mutations, as identified by site local testing
- •or Sponsor central testing: I1171X (where X is any other amino acid), V1180L,
- •G1202R (Cohort A1). NSCLC known to have a known or likely oncogenic-driver
- •mutation in the EGFR gene, as identified by site local testing or Sponsor
- •central testing Liver disease Positive hepatitis B surface antigen test at
- •screening Patients known to be positive for hepatitis C virus antibody HIV
- •infection, patients are excluded if HIV is not adequately controlled (specific
- •criteria apply). Known active tuberculosis Presence of clinically symptomatic
- •interstitial lung disease or interstitial pneumonitis, including radiation
- •pneumonitis Grade >= 2 pneumonitis from prior cCRT or sCRT Symptomatic
- •bradycardia (Cohort A1) Any gastrointestinal (GI) disorder that may affect
- •absorption of oral medications Any other disease, metabolic dysfunction,
- •physical examination finding, or clinical laboratory finding that
- •contraindicates the use of an investigational drug, may affect the
- •interpretation of the results, or may render the patient at high risk from
- •treatment complications Active or history of autoimmune disease or immune
- •deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia,
- •drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active
- •pneumonitis on the screening chest CT scan History of malignancy other than
- •NSCLC within 5 years prior to screening Any concurrent chemotherapy,
- •immunotherapy, biologic, or hormonal therapy for cancer Major surgical
- •procedure, within 4 weeks prior to initiation of study treatment, or
- •anticipation of need for a major surgical procedure during the study Severe
- •infection within 4 weeks prior to initiation of study treatment, including, but
- •not limited to, hospitalization for complications of infection, bacteremia, or
- •severe pneumonia Treatment with systemic immunostimulatory agents Treatment
- •with live, attenuated vaccine Treatment with investigational therapy within 28
- •days prior to initiation of study treatment Treatment with therapeutic oral or
- •IV antibiotics within 2 weeks prior to initiation of study treatment Treatment
- •with systemic immunosuppressive medication Prior treatment with ALK inhibitors.
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- •Prior allogeneic stem cell or solid organ transplantation History of
- •hypersensitivity to alectinib, durvalumab, or any of their excipients.
- •Concurrent enrollment in another clinical study, unless it is an observational
- •(non-interventional) clinical study or the follow-up period of an
- •interventional study Any condition that, in the opinion of the investigator,
研究者
相似试验
招募中
1 期
A Study to Find Out How Effective and Safe Different Treatments are in Patients Who Have a Type of Lung Cancer (Known as Non-Small Cell Lung Cancer [Stage III])on-Small Cell Lung Cancer (NSCLC)MedDRA version: 23.1Level: LLTClassification code 10084713Term: TumorSystem Organ Class: 100000004864EUCTR2021-004149-19-ITF. HOFFMANN - LA ROCHE LTD.320
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: blood-first assay screening trial)Advanced or metastatic Non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000076-28-ITF. HOFFMANN - LA ROCHE LTD.660
招募中
2 期
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST)CancerPACTR202211687583152Hoffmann La Roche682
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: blood-first assay screening trial)Advanced or metastatic Non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000076-28-BEF. Hoffmann-La Roche Ltd987
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: blood-first assay screening trial)EUCTR2017-000076-28-ESRoche Farma S.A (Soc.Unipersonal) que realiza el ensayo568