A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers - M14-359

AbbVie B.V.0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: AbbVie B.V.
入组人数: 22

研究概览入排标准研究者记录与标识符相似试验

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

•1. Subject must be >= 18 years of age.
•2. Life expectancy > 12 weeks (as per Investigator's clinical assessment).
•3. Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC. Subjects with mixed histology tumors will be eligible if the tumor is predominant non-squamous histology and does not include tumor with small cell histology. Subjects must have a pathologist's report confirming non-squamous NSCLC available for collection by the sponsor. Subjects with EGFR mutation (exon 19 deletion or L858R mutation in exon 21) and/or ALK gene rearrangement must have progressed after first line monotherapy treatment with targeted therapy.
•4. Subject must have NSCLC that is not amenable to surgical resection or radiation with curative
•intent at time of study Screening.
•5. Subjects must be current smokers (defined as having > 100 smoking events lifetime and having
•smoked within the past year) or former smokers (defined as having > 100 smoking events lifetime
•and having not smoked within the past year).
•6. Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined
•by RECIST (version 1.1).
•7. Subject must consent to provide archived tissue or cytology sample of NSCLC lesion (primary or
•metastatic) for analysis if available.
•8. Subject must have no history of brain metastases or evidence of CNS tumors at screening
•assessment. Subjects with signs or symptoms of CNS involvement will undergo MRI (or CT scan
•if MRI is contraindicated) to confirm absence of CNS metastases.
•9. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 - 1.
•10. Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the
•discretion of the Investigator.
•11. Subject must have adequate bone marrow, renal and hepatic function as follows:
•Bone Marrow: Absolute neutrophil count (ANC) >= 1,500/mm3 (1.5 × 109/L);
•Platelets >= 100,000/mm3 (100 × 109/L); Hemoglobin >= 9.0 g/dL;
•Renal function: serum calculated creatinine clearance > 50 mL/min according to the
•Cockroft-Gault formula; confirmation of creatinine clearance/GFR may be done by a local direct measurement method (e.g., 24 hour urine collection or radioisotope) at the investigator's discretion;
•Hepatic function: AST and ALT <= 2.5 × ULN unless liver metastases are present, then AST
•and ALT < 5.0 × ULN; bilirubin <= 1.5 × ULN unless Gilbert's Syndrome is present, then
•bilirubin >= 1.5 × ULN.
•12. Female subjects of childbearing potential (i.e., those who are not postmenopausal for at least
•1 year or surgically sterile by bilateral tubal ligation, bilateral oophorectomy or hysterectomy) and
•their male partners should practice at least one of the methods of birth control listed below during
•study and for at least 6 months after treatment with paclitaxel chemotherapy. Male subjects and
•their female partners of childbearing potential should practice at least one of the methods of birth
•control listed below during study and for at least 6 months after treatment with chemotherapy:
•• total abstinence from sexual intercourse (if it is the subject's preferred and usual lifestyle; for
•beginning a minimum one complete menstrual cycle prior to study drug administration and
•to extend 6 months after treatment):
•• vasectomized subject or partner(s); vasec

排除标准

•1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
•polyethoxylated castor oil (Cremophor).
•2. Subject has a known hypersensitivity to platinum compounds.
•3. Subjects with peripheral neuropathy >= grade 2.
•4. Subjects with squamous NSCLC, or those with an untreated EGFR mutation (exon 19 deletion or L858R mutation in exon 21) and/or ALK gene rearrangement. Subjects' EGFR mutation and ALK gene rearrangement status must be known prior to study entry.
•5. A history of seizure within 12 months prior to study entry.
•6. Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC, except adjuvant or neoadjuvant therapy > 12 months prior to C1D-2 or subject has received targeted small molecule monotherapy for EGFR and/or ALK-positive disease <= 14 days prior to C1D-2 or biologic therapy <= 21 days prior to C1D-2.
•7. Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to C1D-2.
•8. Subject has undergone focal External Beam Radiation Therapy (EBRT) to bone <= 2 weeks prior
•to C1D-2; or subject has undergone EBRT to larger fields (i.e., 100 cm2 to thorax) <= 4 weeks
•prior to C1D-2.
•9. Any medical condition, which in the opinion of the Investigator, places the subject at an
•unacceptably high risk for toxicities, or any subject circumstance which prohibits trial
•participation according to local law.
•10. Subject is pregnant or lactating.
•11. Subject has previously been treated with a PARP inhibitor.
•12. The subject has a history of another cancer within the past 3 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell carcinoma of the skin or another in situ cancer that is considered cured by the Investigator (e.g., in situ prostate cancer).

研究者

发起方

AbbVie B.V.

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Randomized, Open-Label, Multicenter Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer Who Are Current or Former Smokers.Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864

EUCTR2014-002565-30-DEAbbVie Deutschland GmbH & Co. KG595