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

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer Stage IIIB
Interventions
Registration Number
NCT03472053
Lead Sponsor
BioMarck Pharmaceuticals, Ltd.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard of CareStandard of CarePemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.
BIO-11006 plus standard of careBIO-11006 plus standard of careAerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.
Primary Outcome Measures
NameTimeMethod
Progression-free survival12 months

Survival period of patients in both arms of the study is measured in absence of tumor progression.

Secondary Outcome Measures
NameTimeMethod
Maintenance of body weight3 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 effects3 months

Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.

Trial Locations

Locations (11)

Vardhman Mahavir Medical College & Hospital

🇮🇳

New Delhi, Delhi, India

Unique Hospital and Research Institute

🇮🇳

Surat, Gujarat, India

Aadhar Health Institute

🇮🇳

Hisar, Hariyana, India

HCG Manavata Cancer Center

🇮🇳

Nashik, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Center

🇮🇳

Pune, Maharashtra, India

Tata Memorial Hospital

🇮🇳

Mumbai, Maharastra, India

Navsanjeevani Hospital

🇮🇳

Nashik, Maharastra, India

Chirayu Cancer Hospital

🇮🇳

Bhopal, MP, India

Sparsh Hospitals and Critical Care

🇮🇳

Bhubaneswar, Odisa, India

SMS Medical College & Hospital

🇮🇳

Jaipur, Rajasthan, India

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Vardhman Mahavir Medical College & Hospital
🇮🇳New Delhi, Delhi, India

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