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Phase II study to investigate the efficacy and safety of ZK 219477 as first-line therapy in chemotherapy naive patients with extensive disease (ED) stage small cell lung cancer (SCLC)

Phase II study to investigate the efficacy and safety of ZK 219477 as first-line therapy in chemotherapy naive patients with extensive disease (ED) stage small cell lung cancer (SCLC)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000597-53-DE
Enrollment
Unknown
Registered
2005-10-31
Start date
2005-12-08
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Extensive disease (ED) stage small cell lung cancer (SCLC)

Interventions

Product Code: SH Y03757A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: not available Current Sponsor code: ZK 219477 Concentration unit: mg milligram(s) Concentration type

Sponsors

Schering AG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males or females aged >= 18 years 2. Histologically or cytologically proven SCLC 3. Stage of extensive disease defined by the presence of distant metastases 4. At least 1 unidimensionally measurable lesion (suitable for modRECIST evaluation) 5. WHO performance status 0 to 1 6. No previous SCLC-related chemotherapy 7. No previous SCLC-related surgery 8. No previous radiotherapy (excepting for brain metastases) 9. Adequate function of major organs and systems • Nervous system: - No Grade 2 or greater peripheral neuropathy • Hematopoietic: - Hemoglobin: >= 10 g/dL - WBC: >= 3,000/mm3 - Absolute neutrophil count: >= 1,500/mm3 - Platelet count: >= 100,000/mm3 • Hepatic: - Total bilirubin: normal - AST/ALT: =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Superior vena cava syndrom or obstruction of any vital structure 2. Untreated malignant hypercalcemia 3. Pleural effusion as the only manifestation of disease 4. Extensive disease amenable to radiation therapy 5. Symptomatic brain metastases requiring whole-brain irradiation 6. Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix 7. Pregnant or breast-feeding women 8. Any condition that in the opinion of the investigator could hamper the compliance with the study protocol

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the efficacy of ZK 219477 in chemotherapy naive patients with extensive disease SCLC (proof of concept);Secondary Objective: To investigate the safety and tolerability of the above treatment;Primary end point(s): Proportion of patients with either complete response (CR) or partial response (PR) as best overall response—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026