A Phase II, Open-Label Trial of Bortezomib (Velcade®) in Combination with Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004963-68-GR

Enrollment

Registered

2007-05-14

Start date

2007-10-16

Completion date

Unknown

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First Line treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer. MedDRA version: 8.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer

Interventions

Trade Name: VELCADE Product Name: VELCADE 3.5 mg powder for solution for injection Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Bortezomib CAS Number: 179324-69-7 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with locally advanced Stage III? (not amenable to curative treatment) or metastatic (Stage IV) NSCLC who have not received prior systemic anti-neoplastic therapy (one additional prior line is allowed if given as neo-adjuvant or adjuvant therapy to tumor resection) will be enrolled in the study. The patient population comprises of men or women, 18 years of age or older. NSCLC must be histologically or cytologically confirmed. Additional inclusion criteria include: measurable disease per RECIST criteria and ECOG performance status score of 0 to 1. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria for this study include: presence of peripheral neuropathy of Grade 2 or greater intensity; significant weight loss (documented =10% body weight in the 6 weeks before randomization); inadequate organ function at the screening visit as defined in the protocol; cardiac disease as defined in the protocol;; active systemic infection requiring treatment; active second malignancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to establish the objective response rate (complete response [CR] + partial response [PR]) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced Stage IIIb not amenable to curative treatment or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease.;Secondary Objective: Secondary objectives for this study include the assessment of the following: Time to tumor progression (TTP) Duration of response (DoR) Progression-free survival (PFS) Overall survival (OS), 6-month, and 12-month survival rates Safety will be evaluated throughout the study by assessment of adverse events, changes in physical examinations, 11-item module Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scores, Eastern Cooperative Oncology Group (ECOG) performance scores, vital signs, and clinical laboratory findings.;Primary end point(s): The primary efficacy endpoint is the objective response rate, which is defined as the proportion of response-evaluable subjects who achieve a confirmed CR or PR per RECIST guidelines.Safety will be evaluated throughout the study by assessment of the incidence, intensity, and type of clinically significant adverse events, and by changes in physical examinations, 11-item module FACT/GOG-Ntx scores, vital signs, clinical laboratory findings and ECOG status. The 11-item module FACT/GOG-Ntx scale will be used as a checklist to assist with the clinical safety evaluation of neuropathic pain and peripheral neuropathy symptoms.	—

Measure

Time frame

Main Objective: The primary objective of this study is to establish the objective response rate (complete response [CR] + partial response [PR]) following treatment with VELCADE in combination with cisplatin plus gemcitabine in patients with locally advanced Stage IIIb not amenable to curative treatment or metastatic (stage IV) non-small cell lung cancer (NSCLC) who have not received prior antineoplastic therapy for advanced disease.;Secondary Objective: Secondary objectives for this study include the assessment of the following: Time to tumor progression (TTP) Duration of response (DoR) Progression-free survival (PFS) Overall survival (OS), 6-month, and 12-month survival rates Safety will be evaluated throughout the study by assessment of adverse events, changes in physical examinations, 11-item module Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scores, Eastern Cooperative Oncology Group (ECOG) performance scores, vital signs, and clinical laboratory findings.;Primary end point(s): The primary efficacy endpoint is the objective response rate, which is defined as the proportion of response-evaluable subjects who achieve a confirmed CR or PR per RECIST guidelines.Safety will be evaluated throughout the study by assessment of the incidence, intensity, and type of clinically significant adverse events, and by changes in physical examinations, 11-item module FACT/GOG-Ntx scores, vital signs, clinical laboratory findings and ECOG status. The 11-item module FACT/GOG-Ntx scale will be used as a checklist to assist with the clinical safety evaluation of neuropathic pain and peripheral neuropathy symptoms.

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Countries

Greece

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026