A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin&reg;) in patients with non-squamous non small cell lung cancer (NAVAL study)

A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin&reg;) in patients with non-squamous non small cell lung cancer (NAVAL study) - A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin&reg;) in patients with non-squamous non small cell lung cancer (NAVAL study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004278

Enrollment

Registered

2010-10-01

Start date

2010-06-01

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

Non-squamous non-small cell lung cancer

Interventions

After Cisplatin (75mg/m2) + Pemetrexed (500mg/m2) + Bevacizumab (15mg/kg) day 1 q3w 3 cycles, lung resection with lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or pathologically proven non-squamous non-small cell lung cancer 2. Resectable clinical stage II/IIIA (UICC-7) 3. Without previously treatment for lung cancer 4. Age >=20, <75 y 5. ECOG PS 0-1 6. Expected FEV 1.0 > 1.0L after lung resection 7. Adequate organ function 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Uncontrollable systemic disease (hyper tension or diabetes mellitus) 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. Therapeutic anticoagulation; regular use of aspirin (>325 mg/day) 9. Severe GI disease 10. Current or previous (within the last 1 year) history of GI perforation or diverticultis 11. History of severe heart disease 12. Severe diarrhea 13. Severe drug allergy 14. Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp 15. History of active double cancer 16. History of pregnancy or lactation 17. 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
Pathological complete resection rate	—

Secondary

Measure	Time frame
Relapse free survival, 2Y,5Y survival, Response rate, Adverse event	—

Countries

Japan

Contacts

Public ContactYasuhiro Tsutani

Hiroshima University Hospital Thoracic Surgery

tsutani@hiroshima-u.ac.jp0822575869

Outcome results

None listed

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

A feasibility study of neoadjuvant therapy with cisplatin, pemetrexed, and bevacizumab (Avastin&amp;reg;) in patients with non-squamous non small cell lung cancer (NAVAL study)