An open-label, phase Ib, dose-escalation trial on the safety, tolerability, pharmacokinetics, immunogenicity, biological effects and antitumor activity of EMD 521873 in combination with local irradiation (20 Gy) of primary tumors or metastases in subjects with non-small cell lung cancer stage IIIb with malignant pleural effusion or stage IV with disease control (partial response or stable disease) after application of 4 cycles of platinum-based, first-line chemotherapy.

An open-label, phase Ib, dose-escalation trial on the safety, tolerability, pharmacokinetics, immunogenicity, biological effects and antitumor activity of EMD 521873 in combination with local irradiation (20 Gy) of primary tumors or metastases in subjects with non-small cell lung cancer stage IIIb with malignant pleural effusion or stage IV with disease control (partial response or stable disease) after application of 4 cycles of platinum-based, first-line chemotherapy. - EMD 521873 plus Radiotherapy in NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34011

Enrollment

Registered

2009-03-03

Start date

2009-03-15

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Lung cancer non-small cell lung carcinoma

Interventions

This is a trial with increasing doses of Selectikine in combination with radiation. Groups of 3-6 patients (cohorts) will enter the study. The first cohort will be treated at the dose level of 0.15

and on days 1-3 and 8 of all subsequent cycles.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Male or female, aged >=18 years of age • Signed written informed consent • Effective contraception for male and female subjects of childbearing potential • ECOG performance status 0 or 1 • Adequate hematological function defined by WBC >=3 x 109/L, neutrophils >=1.5 x 109/L, lymphocyte count >=0.5 x 109/L, platelet count >=100 x 109/L; hemoglobin >=9 g/L • Estimated creatinine clearance >=50 mL/min according to the Cockcroft - Gault formula or 24-h urine sampling • Adequate hepatic function defined by a total bilirubin level

Exclusion criteria

Exclusion criteria: • Requirement for immunosuppressive treatment with the exception of inhalative corticosteroids or low-dose systemic corticosteroids (prednisone equivalent dose = NYHA II, LVEF

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence of DLTs occurring during the first cycle of administration of any dose of EMD 521873 following radiotherapy. This endpoint will be used to determine the MTD of EMD 521873.	—

Secondary

Measure	Time frame
Additional safety variables (AEs, laboratory parameters, vital signs); serum levels of anti-EMD 521873 antibodies to characterize the immunogenicity of EMD 521873; objective tumor response, change in circulating tumor cell numbers; progression-free survival and overall survival; changes in leukocyte subsets and molecular markers of immune activation	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)