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Clinical Trials List

Protocol NumberM14-359
Completed

2014-09-30 - 2020-02-21

Phase III

Terminated5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 夏和雄 Division of Hematology & Oncology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

non-squamous Non-Small Cell Lung Cancer.

Objectives

The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in current smokers with metastatic or advanced NSCLC.

Test Drug

Veliparib (ABT-888)

Active Ingredient

Veliparib (ABT-888)

Dosage Form

capsule

Dosage

40

Endpoints

1. Overall survival (OS): will be reported by the Investigator until radiographic progression or death. After the final visit, survival information will be collected at 2-month intervals (or as requested by sponsor to support data analysis).

Objective response rate (ORR): will be derived per RECIST version 1.1. Radiographic tumor
assessments for response will be conducted by CT scanning prior to C3D1, prior to C5D1, every 9 weeks until 1 year after beginning treatment, and then every 12 weeks.

Progression-free survival (PFS): will be derived according to radiographic progression per RECIST version 1.1 or death. Radiographic tumor assessments for response will be conducted by CT scanning prior to C3D1, prior to C5D1, every 9 weeks until 1 year after beginning treatment, and then every 12 weeks.

Quality of Life (QoL): will be assessed at baseline, C3D1, C5D1, every 9 weeks until 1 year after beginning treatment, and then every 12 weeks until radiographic progression and at the 30-day follow-up visits via the NCCN-Functional Assessment of Cancer Therapy (FACT) Lung Symptom Index-17 (NFLSI-17) questionnaire and the European Quality of Life-5 Dimensions (EQ-5D-5L) questionnaires.

Duration of overall response (DOR): will be derived according to radiographic progression per RECIST version 1.1. Radiographic tumor assessments for response will be conducted by CT scanning prior to C3D1, prior to C5D1, every 9 weeks until 1 year after beginning treatment, and then every 12 weeks.

ECOG performance status: will be determined by the Investigator at each assessment

Inclution Criteria

1. Subject must be ≥ 18 years of age. Life expectancy > 12 weeks (as per Investigator's clinical assessment)
2. Subject must have cytologically or histologically confirmed non-squamous NSCLC.
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).
3. Subject must have NSCLC that is not amenable to surgical resection or radiation
with curative intent at time of study Screening.
4. Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1).

Exclusion Criteria

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 known EGFR mutation (exon 19 deletion or L858R mutation in exon 21) or ALK gene rearrangement.
5. Subject has received prior cytotoxic chemotherapy for metastatic NSCLC.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    525 participants

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