Non Small Cell Lung Cancer Stage IIIB
Conditions
Keywords
Lung cancer, non small cell, metastasis
Brief 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.
Detailed description
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.
Interventions
DRUGBIO-11006 plus standard of care
BIO-11006 is administered 125mg BID plus standard of care.
DRUGStandard of Care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
Sponsors
BioMarck Pharmaceuticals, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 12 months | Survival period of patients in both arms of the study is measured in absence of tumor progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of body weight | 3 and12 months | Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia. |
| Treatment emergent adverse effects | 3 months | Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated. |
Countries
India
Outcome results
None listed