A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Chandigarh, India, 160012
- Nehru Hospital & Post Graduate Institute of Medical Education
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Delhi
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New Delhi, Delhi, India, 110029
- Vardhman Mahavir Medical College & Hospital
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Gujarat
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Surat, Gujarat, India, 395002
- Unique Hospital and Research Institute
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Hariyana
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Hisar, Hariyana, India, 125005
- Aadhar Health Institute
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MP
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Bhopal, MP, India, 462030
- Chirayu Cancer Hospital
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Maharashtra
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Nashik, Maharashtra, India, 422004
- HCG Manavata Cancer Center
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital & Research Center
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Maharastra
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Mumbai, Maharastra, India, 400012
- Tata Memorial Hospital
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Nashik, Maharastra, India, 422002
- Navsanjeevani Hospital
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Odisa
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Bhubaneswar, Odisa, India, 751007
- Sparsh Hospitals and Critical Care
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Rajasthan
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Jaipur, Rajasthan, India, 302016
- SMS Medical College & Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: BIO-11006 plus standard of care
Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.
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BIO-11006 is administered 125mg BID plus standard of care.
Other Names:
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EXPERIMENTAL: Standard of Care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.
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Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression-free survival
Time Frame: 12 months
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Survival period of patients in both arms of the study is measured in absence of tumor progression.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintenance of body weight
Time Frame: 3 and12 months
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Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.
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3 and12 months
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Treatment emergent adverse effects
Time Frame: 3 months
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Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Devesh Verma, PhD, Cliantha Research, India
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-NSCLC-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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