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

Non Small Cell Lung Cancer Stage IIIB Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472053
• Other study ID #: BIO-NSCLC-001
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: BioMarck Pharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Stage IIIB

Intervention

Drug:
• BIO-11006 plus standard of care
BIO-11006 is administered 125mg BID plus standard of care.
• Standard of Care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.

Locations

Country	Name	City	State
India	Chirayu Cancer Hospital	Bhopal	MP
India	Sparsh Hospitals and Critical Care	Bhubaneswar	Odisa
India	Nehru Hospital & Post Graduate Institute of Medical Education	Chandigarh
India	Aadhar Health Institute	Hisar	Hariyana
India	SMS Medical College & Hospital	Jaipur	Rajasthan
India	Tata Memorial Hospital	Mumbai	Maharastra
India	HCG Manavata Cancer Center	Nashik	Maharashtra
India	Navsanjeevani Hospital	Nashik	Maharastra
India	Vardhman Mahavir Medical College & Hospital	New Delhi	Delhi
India	Deenanath Mangeshkar Hospital & Research Center	Pune	Maharashtra
India	Unique Hospital and Research Institute	Surat	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
BioMarck Pharmaceuticals, Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Survival period of patients in both arms of the study is measured in absence of tumor progression.	12 months
Secondary	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
Secondary	Treatment emergent adverse effects	Treatment-emergent adverse events including headache, bronchitis, dyspnea, cough, pyrexia, chest discomfort and liver function will be evaluated.	3 months