Phase 2
Completed N=165
A Study of Paclitaxel/Carboplatin With or Without CDP791 in Patients With Lung Cancer
Carcinoma · non-squamous non-small cell lung cancer
Source: ClinicalTrials.gov NCT00152477 ↗
Enrolled (actual)
165
Serious AEs
32.1%
Results posted
Apr 2022
Primary outcomePrimary: Tumor Response Rate (RR) — 0; 0; 0; 0 percentage of participants — p==0.384
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate (RR) |
0; 0; 0; 0; 20; 26.4 | =0.384 |
| SECONDARY Progression Free Survival (PFS) |
24.14; 26.86; 26.86; 25.43 | — |
| SECONDARY Time to Treatment Failure |
13.21; 21.71; 18.43; 24.29 | — |
| SECONDARY Overall Survival |
36.14; 47.14; 46.57; 47.57 | — |
| SECONDARY Duration of Overall Response |
21.14; 21.14; 21.14; 18.00 | — |
| SECONDARY Time to Response |
8.57; 9.14; 11.86; 9.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00152477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.