A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMarck Pharmaceuticals, Ltd.
• Treatments: Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

1. Patients who are physically able to self administer drug by nebulizer;

2. Measurable disease per RECIST Version 1.1;

3. Female patients of child bearing age must have a negative pregnancy test;

4. ECOG 0-2;

5. Written informed consent;

Exclusion Criteria:

1. Candidates for curative surgery and/or radiation therapy;

2. Baseline ANC<2000 cells/mm cube; platelet count <100,000 cells/mm cube

3. Creatinine clearance <45 mL/min;

4. Billirubin >2 x the upper limit of normal

5. Known history of HIV, hepatitis B, hepatitis C or tuberculosis;

6. Current pneumonia or idiopathic pulmonary fibrosis;

7. Hypersensitivity to test drug, pemetrexed, or carboplatin.