CBDCA, PTX and BV for NSCLC (non-sq) with IP

Phase 2

• Conditions: on-squamous, non-small cell lung cancer; Lung cancer

• Registration Number: JPRN-jRCTs061180046
• Lead Sponsor: Katakami Nobuyuki

Brief Summary

Combination of carboplatin, paclitaxel and bevacizumab is a promising treatment for non-squamous, non-small cell lung cancer with idiopathic interstitial pneumonitis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Study Completion: 2020-10-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1)Non-squamous, non-small cell lung cancer
2)No prior radiotherapy to primary tumor
3)Age over twenty
4)Idiopathic interstitial pneumonia
5)Measurable lesion
6)The following procedures or operations should be completed before protocol treatment
1.major surgery (including exploratory thoracotomy): more than 4 weeks
2.chest tube drainage: more than 2 weeks
3.incisional biopsy or treatment of injury: more than 2 weeks
4.bronchoscopic tumor biopsy, bronchoscopic needle aspiration biopsy, or implantation of central venous port: more than 1 week.
7) ECOG performance status 0 or 1
8) Adequate organ function
WBC>=3000/mm3 and neutrophil count >=2000/mm3
Hgb>=10.0g/dL, Plt>=100,000/mm3, T-bil=<1.5mg/dL, AST=<100 IU/L, ALT=<100 IU/L, CRN=<1.5mg/dL, proteinuria=<1+, or =< 2g/day
9) PaO2>=60.0 torr or SpO2>=92.0 % (room air)
10) Life expectancy >= 3 months
11) Written informed consent

Exclusion Criteria

1) Secondly interstitial pneumonia.
2) History of acute exacerbation of interstitial pneumonia within 3 months.
3) Subacute progression of interstitial pneumonia within 3 months.
4) Using prednisolone or immune-suppressive agent.
5) Need to home oxygen therapy.
6) Past history of severe drug allergy.
7) Active infectious disease.
8) Severe complications.
9) Symptomatic brain metastasis.
10) Uncontrollable effusion.
11) Hemoptysis.
12) Apparent invasion into great vessels, apparent pulmonary cavitary lesion.
13) Active peptic ulcer.
14) Bleeding tendency.
15) Unhealed major operation wounds.
16) Thrombosis.
17) Multiple primary cancers with disease-free period less than 2 years, except carcinoma in situ or intra mucosal disease cured by local therapy.
18) Any ineligible case judged by physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
overall survival, progression free survival,<br>time to treatment failure, adverse event