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

This randomized, open label, multicenter Phase 2 study is to evaluate safety and efficacy of BIO-11006 in Stage IIIB Non Small Cell Lung cancer (NSCLC) patients who are not candidates for curative surgery, radiation, or immunotherapy and who are also receiving Pemetrexed and Carboplatin as standard of care (SOC). This study will be conducted at ten clinical centers in India under an IND from US-FDA and an IND from Indian FDA.

This is a parallel 2- Arm study in which a total of 60 patients will be randomized. One Arm of 30 subjects will receive aerosolized 125mg BIO-11006 BID using Pari eFlow nebulizer in conjunction with SOC chemotherapy (Pemetrexed plus Carboplatin). A second Arm of 30 subjects will receive only SOC chemotherapy (Pemetrexed plus Carboplatin). The treatment period will be three months and nine months survival follow up period (every three months).

Primary efficacy endpoint will be Progression-free survival (PFS) in patients who receive BIO-11006 plus SOC compared to those who receive SOC alone. The secondary efficacy endpoints will include: a. Response rate at three months (4 cycles) per RECIST V1.1; (b) overall survival; and (c) patient body weight maintenance.

Inclusion criteria

• Patients who are physically able to self administer drug by nebulizer;
• Measurable disease per RECIST Version 1.1;
• Female patients of child bearing age must have a negative pregnancy test;
• ECOG 0-2;
• Written informed consent;

Exclusion criteria

• Candidates for curative surgery and/or radiation therapy;
• Baseline ANC<2000 cells/mm cube; platelet count <100,000 cells/mm cube
• Creatinine clearance <45 mL/min;
• Billirubin >2 x the upper limit of normal
• Known history of HIV, hepatitis B, hepatitis C or tuberculosis;
• Current pneumonia or idiopathic pulmonary fibrosis;
• Hypersensitivity to test drug, pemetrexed, or carboplatin.