A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer

A randomized phase II trial of induction CDDP +PEM +BEV versus CDDP + PEM with concurrent radiotherapy followed by surgical resection in patients with pathologically confirmed stage IIIA-N2 non-squamous- cell non-small cell lung cancer - Personalized Induction Therapy Clinical Trial-1:PIT-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011941

Enrollment

Registered

2013-10-02

Start date

2013-10-01

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

Stage IIIA-N2 Non-squamous, Non-small cell lung cancer

Interventions

&quot

Group A : Induction chemotherapy (CDDP + PEM + BEV) The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM, and bevacizumab. &quot

Group B :Induction concurrent chemoradiotherapy (CDDP + PEM + RT45Gy) The surgical resection is performed after 3 cycles of chemotherapy with CDDP, PEM and RT45Gy. &quot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "1. Histologically or cytologically proven non-squamous non-small cell lung cancer, diagnosed using specimen material obtained from primary tumor or metastastatic lymph node 2. Stage IIIA- pathologically proven N2 disease 3. Without previously treatment for lung cancer 4. Age 20-75 y 5. ECOG PS 0-1 6. Expected FEV 1.0 ,over800ml after lung resection, SpO2 Room air over95% 7. Adequate organ function 8. Written informed consent "

Exclusion criteria

Exclusion criteria: "1.Uncontrollable systemic disease.hyper tension, diabetes mellitus etc. 2. Current history of hemosputum or hemoptysis 3. Evidence of bleeding diathesis or coagulopathy 4. Cavity in lung tumor or great vessel involvement 5. Current or previous within the last 1 year history of cerebrovascular disease 6. Traumatic fracture of un recovery 7. History of active infection 8. hepatitis B surface antigen positive 9. Therapeutic anticoagulation; regular use of aspirin ,over 325 mg/day. 10. Severe GI disease 11. Current or previous within the last 1 year history of GI perforation or diverticultis 12. History of severe heart disease 13. Severe diarrhea 14. Severe drug allergy 15. Investigational new drug or the unapproved drug is administered 16. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 17. History of active double cancer 18. History of pregnancy or lactation 19. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator "

Design outcomes

Primary

Measure	Time frame
2-year progression-free survival	—

Secondary

Measure	Time frame
5-year progression-free survival 2-year and 5-year overall survival Completion rate of the protocol treatment Complete resection rate Radiological response rate Down staging rate Safety Pathological response (Ef) Tumor markers (CEA/CYFRA) SUVmax on FDG-PET scan	—

Countries

Japan

Contacts

Public ContactKazuya Takamochi

Juntendo University Thoracic Surgery

ktakamo@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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