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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer Stage IIIB
• Intervention / Treatment: Drug: BIO-11006 plus standard of care; Drug: Standard of Care

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
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Nehru Hospital & Post Graduate Institute of Medical Education
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Vardhman Mahavir Medical College & Hospital
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Unique Hospital and Research Institute
  • Hariyana
    • Hisar, Hariyana, India, 125005
      • Aadhar Health Institute
  • MP
    • Bhopal, MP, India, 462030
      • Chirayu Cancer Hospital
  • Maharashtra
    • Nashik, Maharashtra, India, 422004
      • HCG Manavata Cancer Center
    • Pune, Maharashtra, India, 411004
      • Deenanath Mangeshkar Hospital & Research Center
  • Maharastra
    • Mumbai, Maharastra, India, 400012
      • Tata Memorial Hospital
    • Nashik, Maharastra, India, 422002
      • Navsanjeevani Hospital
  • Odisa
    • Bhubaneswar, Odisa, India, 751007
      • Sparsh Hospitals and Critical Care
  • Rajasthan
    • Jaipur, Rajasthan, India, 302016
      • SMS Medical College & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Survival period of patients in both arms of the study is measured in absence of tumor progression.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of body weight	Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.	3 and12 months
Treatment emergent adverse effects	Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.	3 months

Collaborators and Investigators

• Sponsor: BioMarck Pharmaceuticals, Ltd.
• Investigators: Study Director: Devesh Verma, PhD, Cliantha Research, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): December 30, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (ACTUAL): March 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Lung cancer; metastasis; non small cell
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BIO-NSCLC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No