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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Study of the Safety and Efficacy of BIO-11006 in Treatment of Advanced Non-Small Cell Lung Cancer in Patients Who Are Not Candidates for Curative Surgery and/or Radiation and Who Are Receiving Pemetrexed and Carboplatin

Conditions
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Non Small Cell Lung Cancer Stage IIIB

Intervention / Treatment
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* Drug: BIO-11006 plus standard of care
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in 1:1 ratio to either BIO-11006 plus Standard of Care (intervention) or Standard of Care (Pemetrexed plus Carboplatin) (intervention).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIO-11006 plus standard of care<br>Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months. | Drug: BIO-11006 plus standard of care<br>* BIO-11006 is administered 125mg BID plus standard of care.<br>* Other names: Active drug plus standard of care;|
| Experimental: Standard of Care<br>Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months. | Drug: Standard of Care<br>* Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Survival period of patients in both arms of the study is measured in absence of tumor progression. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of body weight | Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia. | 3 and12 months | 
| Treatment emergent adverse effects | Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, non small cell, metastasis