Clinical trial · Interventional
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
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
NCT00152477CI-TRIAL-00057725completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Squamous Non-Small-Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| CDP791 10mg/kg | Drug | — | UNRESOLVED |
| CDP791 20mg/kg | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Carboplatin/Paclitaxel
- description
- Carboplatin and paclitaxel alone.
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Carboplatin/Paclitaxel/CDP791 10mg
- description
- Carboplatin and paclitaxel plus CDP791 10mg/kg
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: CDP791 10mg/kg
- Drug: CDP791 20mg/kg
- type
- EXPERIMENTAL
- label
- Carboplatin/Paclitaxel/CDP791 20mg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion Criteria: * Male and female subjects with Stage IIIb (with malignant pleural effusion or if no pleural effusion is present subjects who are not candidates for combined modality therapy), Stage IV, or recurrent non-squamous, non-small-cell lung carcinoma. * The subject must be aged 18 years or above. * The subject must have ECOG performance status of 0 or 1 and a life expectancy of at least three months. * Subjects will have measurable disease. * The subject must be able to understand the information provided to them and to give written informed consent. * Female subjects must be either postmenopausal, surgically sterilized, or using a method of contraception judged reliable by the Investigator. * Male subjects must be using a method of contraception judged reliable by the Investigator. Exclusion Criteria: * Subjects with squamous cell lung carcinoma. * Subjects with lung lesions located centrally in the chest that involve major blood vessels. * Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for five years or more. * Presence of additional major chronic disease such as hepatic or renal dysfunction, cardiac dysfunction, peripheral vascular disease, evidence of a myocardial infarction within six months of Screening visit, tuberculosis or epilepsy. * Subjects known to be infected with hepatitis B or C virus or HIV 1 or 2. * Any evidence of serious active infection (ie requiring an iv antibiotic or antiviral agent). Exclusion Criteria:
References
Publications (0)
Data not yet available
No reference posted for this study.