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

NCT03472053 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BIO-NSCLC-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

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.

Conditions

Non Small Cell Lung Cancer Stage IIIB

Keywords

Lung cancer; non small cell; metastasis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

  12 months

Secondary Outcomes (2)

• Maintenance of body weight

  3 and12 months

• Treatment emergent adverse effects

  3 months

Study Arms (2)

BIO-11006 plus standard of care

EXPERIMENTAL

Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.

Drug: BIO-11006 plus standard of care

Standard of Care

EXPERIMENTAL

Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months.

Drug: Standard of Care

Interventions

BIO-11006 plus standard of care DRUG

BIO-11006 is administered 125mg BID plus standard of care.

Also known as: Active drug plus standard of care

BIO-11006 plus standard of care

Standard of Care DRUG

Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.

Also known as: Active comparator

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioMarck Pharmaceuticals, Ltd.: lead

Study Sites (11)

Unique Hospital and Research Institute

Surat, Gujarat, 395002, India

Location

Aadhar Health Institute

Hisar, Haryana, 125005, India

Location

Chirayu Cancer Hospital

Bhopal, Madhya Pradesh, 462030, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Navsanjeevani Hospital

Nashik, Maharashtra, 422002, India

Location

HCG Manavata Cancer Center

Nashik, Maharashtra, 422004, India

Location

Deenanath Mangeshkar Hospital & Research Center

Pune, Maharashtra, 411004, India

Location

Vardhman Mahavir Medical College & Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Sparsh Hospitals and Critical Care

Bhubaneswar, Odisa, 751007, India

Location

SMS Medical College & Hospital

Jaipur, Rajasthan, 302016, India

Location

Nehru Hospital & Post Graduate Institute of Medical Education

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Devesh Verma, PhD

  Cliantha Research India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 21, 2018
• Study Start: February 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

IN (11)