At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed NSCLC without prior chemotherapy or biological therapy
- ✓Stage IIIB (N3 and/or pleural/pericardial effusion) or Stage IV disease not amenable to surgery or curative radiation
- ✓Life expectancy of at least 12 weeks
- ✓At least one unidimensionally measurable lesion (≥10 mm by spiral CT or ≥20 mm by standard techniques) per RECIST
- ✕Any prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neoadjuvant therapy
- ✕CNS metastases, unless successfully treated locally and off corticosteroids for ≥21 days; leptomeningeal disease is excluded
- ✕Second primary malignancy (with certain exceptions: in situ cervical carcinoma, non-melanomatous skin cancers, localized prostate cancer, superficial bladder cancer, or malignancy treated ≥3 years prior with no recurrence)
- ✕Eligible for combined-modality therapy with curative intent (chemotherapy, radiation, and/or surgery), particularly N3 IIIB disease with potential cure rates up to 10%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1-2 Study of Weekly OGX-011 Plus a Gemcitabine/Platinum-Based Regimen in Patients With Stage IIIB or IV Non Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating custirsen sodium for Non-small Cell Lung Cancer. Completed, enrolled 85 participants across 15 sites in 2 countries.
Detailed Summary
This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.
Study Details
Timeline
Interventions
Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days)