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

• ClinicalTrials.gov Identifier: NCT03472053
• Recruitment Status: Completed
• First Posted: March 21, 2018
• Last Update Posted: May 19, 2020
• Sponsor: BioMarck Pharmaceuticals, Ltd.
• Information provided by (Responsible Party): BioMarck Pharmaceuticals, Ltd.

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: December 30, 2019
• Actual Study Completion Date: December 30, 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

India

Vardhman Mahavir Medical College & Hospital

New Delhi, Delhi, India, 110029

Unique Hospital and Research Institute

Surat, Gujarat, India, 395002

Aadhar Health Institute

Hisar, Hariyana, India, 125005

HCG Manavata Cancer Center

Nashik, Maharashtra, India, 422004

Deenanath Mangeshkar Hospital & Research Center

Pune, Maharashtra, India, 411004

Tata Memorial Hospital

Mumbai, Maharastra, India, 400012

Navsanjeevani Hospital

Nashik, Maharastra, India, 422002

Chirayu Cancer Hospital

Bhopal, MP, India, 462030

Sparsh Hospitals and Critical Care

Bhubaneswar, Odisa, India, 751007

SMS Medical College & Hospital

Jaipur, Rajasthan, India, 302016

Nehru Hospital & Post Graduate Institute of Medical Education

Chandigarh, India, 160012

Sponsors and Collaborators

BioMarck Pharmaceuticals, Ltd.

Investigators

• Study Director: Devesh Verma, PhD; Cliantha Research, India

More Information

• Responsible Party: BioMarck Pharmaceuticals, Ltd.
• ClinicalTrials.gov Identifier: NCT03472053
• Other Study ID Numbers: BIO-NSCLC-001
• First Posted: March 21, 2018
• Last Update Posted: May 19, 2020
• Last Verified: May 2020

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; metastasis

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms