Phase I/II study of a novel peptide vaccination therapy, CDCA1 and KOC1, for previously treated advanced non-small-cell lung cancer

Phase 1

• Conditions: previously treated advanced non-small-cell lung cancer

• Registration Number: JPRN-UMIN000005087
• Lead Sponsor: Showa University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Patients were excluded if they have already received vaccination therapy, they had severe heart disease, active infection, severe drug allergy, other serious underlying medical conditions, symptomatic brain metastasis, or an active second malignancy, and they received steroids or immunosuppressing agent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety, maximum tolerated dose, and recommended dose in phase I. To assess the progression-free survival in phase II.

Secondary Outcome Measures

Name	Time	Method
To assess the response rates, QOL, and the immunological responses in phase I. To assess the response rates, the safety, overall survival, QOL, and the immunological responses in phase II.