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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03472053
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Stage IIIB Drug: BIO-11006 plus standard of care Drug: Standard of Care Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: BIO-11006 plus standard of care
Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.
Drug: BIO-11006 plus standard of care
BIO-11006 is administered 125mg BID plus standard of care.
Other Name: Active drug plus standard of care

Experimental: Standard of Care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.
Drug: Standard of Care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
Other Name: Active comparator

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]
    Survival period of patients in both arms of the study is measured in absence of tumor progression.

Secondary Outcome Measures :
  1. Maintenance of body weight [ Time Frame: 3 and12 months ]
    Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.

  2. Treatment emergent adverse effects [ Time Frame: 3 months ]
    Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03472053

Contact: Brian Dickson, MD 919-607-8490
Contact: Indu Parikh, PhD 919-593-1274

Vardhman Mahavir Medical College & Hospital Recruiting
New Delhi, Delhi, India, 110029
Contact: Neeraj Singh, MS    +91-880-048-8618   
Principal Investigator: Satya P Kataria, MD         
Sub-Investigator: Kaushal Kalra, MD         
Sub-Investigator: Mukesh Nagar, MD         
Unique Hospital and Research Institute Recruiting
Surat, Gujarat, India, 395002
Contact: Ankit Patel, MD    +91 982 540 4202   
Contact: Tanveer Maksood, MD    +91 990 991 8887   
Aadhar Health Institute Recruiting
Hisar, Hariyana, India, 125005
Contact: Harish Sharma, MD    +91-989-653-9125   
Contact: Coordinator    +91-701-819-6594   
Principal Investigator: Lovenish Goyal, MD         
HCG Manavata Cancer Center Recruiting
Nashik, Maharashtra, India, 422004
Contact: Nishtha Paleja, MBBS    +91-982-325-8862   
Principal Investigator: Rajnish Nagarkar, MSBSS         
Sub-Investigator: Vijay Palwe, MD         
Deenanath Mangeshkar Hospital & Research Center Recruiting
Pune, Maharashtra, India, 411004
Contact: A Asmita, BS    +91-996-008-4830   
Principal Investigator: Chetan Deshmukh, MD         
Sub-Investigator: Padmaj Kulkarni, MD         
Tata Memorial Hospital Recruiting
Mumbai, Maharastra, India, 400012
Contact: Vijay Patil, MD    +91-986-938-2266   
Contact: Coordinator    +91-983-394-4571   
Principal Investigator: Amit Joshi, MD         
Sub-Investigator: Kumar Prabhash, MD         
Navsanjeevani Hospital Recruiting
Nashik, Maharastra, India, 422002
Contact: Bhushan Nemade, MD    +91 976 612 6162   
Contact: Sulabhchandra Barmare, MD    +91 973 324 4670   
Chirayu Cancer Hospital Recruiting
Bhopal, MP, India, 462030
Contact: Hakimudin Malvi, MD    +91-942-567-2336   
Principal Investigator: Tarini P Sahoo, MD         
Sparsh Hospitals and Critical Care Recruiting
Bhubaneswar, Odisa, India, 751007
Contact: Siddharth Mohanty, MS    +91-732-707-8993   
Principal Investigator: Ghanashyam Biswas, MD         
Sub-Investigator: Bharat Das, MD         
SMS Medical College & Hospital Recruiting
Jaipur, Rajasthan, India, 302016
Contact: Shivraj Sharma, MD    +91-141-400-7619   
Contact: Coordinator    +91-756-823-0335   
Principal Investigator: Narendra Khippal, MD         
Sub-Investigator: Shantanu Sharma, MD         
Sub-Investigator: Sandeep Jasuja, MD         
Nehru Hospital & Post Graduate Institute of Medical Education Recruiting
Chandigarh, India, 160012
Contact: M Shashank, MS    +91-988-805-8173   
Principal Investigator: Navneet Singh, MD         
Sub-Investigator: D Behra, MD         
Sub-Investigator: R Kapoor, MD         
Sponsors and Collaborators
BioMarck Pharmaceuticals, Ltd.
Study Director: Devesh Verma, PhD Cliantha Research, India

Responsible Party: BioMarck Pharmaceuticals, Ltd. Identifier: NCT03472053     History of Changes
Other Study ID Numbers: BIO-NSCLC-001
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BioMarck Pharmaceuticals, Ltd.:
Lung cancer
non small cell

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors