At a glance
ClinicalIndex Comparison Record- ✓Stage IIIb (with malignant pleural effusion or not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma
- ✓Age ≥18 years
- ✓ECOG performance status 0 or 1
- ✓Life expectancy of at least 3 months
- ✕Squamous cell lung carcinoma
- ✕Lung lesions involving major blood vessels located centrally in the chest
- ✕Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of cervix; prior malignancies allowed if disease-free ≥5 years
- ✕Major chronic diseases including hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, myocardial infarction within 6 months, tuberculosis, or epilepsy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Part, Open Label Phase II Trial: Part One, Dose Escalation Safety; Part Two, Randomized/Comparing CDP791 Plus Carboplatin/Paclitaxel With Carboplatin/Paclitaxel Alone in Subjects With Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Carboplatin, Paclitaxel, and 2 other interventions for Carcinoma and Non-Squamous Non-Small-Cell Lung Cancer. Completed, enrolled 165 participants across 21 sites in 3 countries.
Detailed Summary
A 2-part study to examine safety, tolerability and pharmacokinetics (part 1), and anti-tumour effects (part 2), of CDP791 combined with carboplatin and paclitaxel.
Study Details
Timeline
Interventions
10mg/mL vial AUC6. Dosed intravenously over 15-30 minutes immediately following paclitaxel, Day 0 of each cycle. Each cycle to be repeated every three weeks for a maximum of six cycles.
6mg/mL vial 200 mg/m2 iv over three hours, Day 0. Each cycle to be repeated every 3 weeks for a maximum of 6 cycles.
CDP791 20mg/mL vial CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.
CDP791 20mg/kg CDP791 diluted (10mg/kg or 20mg/kg) in 0.9% saline will be given as a 200mL iv infusion over approximately 60 minutes following administration of standard chemotherapy.