Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients

Randomized phase III trial of adjuvant chemo-immunotherapy with dendritic cells and activated killer cells in patients with resected primary lung cancer patients - Immunotherapy for post-surgical lung cancer patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007525

Enrollment

160

Registered

2012-04-01

Start date

2007-04-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Primary lung cancer

Interventions

group A: immunotherapy and chemotherapy chemotherapy: CBDCA+GEM orCBDCA+PTX or CBDCA+PEM 4 courses every month 2 courses of Induction chemotherapy are applied for advanced cases Immunotherapy: ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)surgically resected primary non-small cell lung cancer patients 2) stage IIA -IV with no residual cancer after surgery 3) PS=0 or 1 4)more than 3X109(3 billion) activated killer cells are available from regional lymoh nodes for one course of immunotherapy 5) postsurgial treatment can be started within 2 months after surgery 6)chief organ functions are preserved 12000mm3 > WBC> 3000/mm3 Plt >100,000/mm3 Hb> 8.0g/dl TBil<2mg/dl AST,ALT <100IU/L Creatinin <1.2mg/dl 9)written informed consent are obtained

Exclusion criteria

Exclusion criteria: 1 with other active cancer 2 with viral infection (HIV,HBS,HCV) 3 small cell lung cancer( combied SCLC are included for the study)

Design outcomes

Primary

Measure	Time frame
2 year survival,5 year survival	—

Secondary

Measure	Time frame
recurrence free survival, safety, seide effect	—

Countries

Japan

Contacts

Public ContactHideki Kimura M.D.

Chiba Cancer Center DIvision of Thoracic Diseases

hkimura@chiba-cc.jp043-264-5431

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026