Clinical trial NCT03472053: A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer Stage IIIB
Keywords: Lung cancer
non small cell
metastasis
Lead sponsor: BioMarck Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Maintenance of body weight
timeFrame: 3 and12 months
measure: Treatment emergent adverse effects
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Vardhman Mahavir Medical College & Hospital
state: Delhi
city: Surat
country: India
facility: Unique Hospital and Research Institute
state: Gujarat
city: Hisar
country: India
facility: Aadhar Health Institute
state: Hariyana
city: Nashik
country: India
facility: HCG Manavata Cancer Center
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Center
state: Maharashtra
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharastra
city: Nashik
country: India
facility: Navsanjeevani Hospital
state: Maharastra
city: Bhopal
country: India
facility: Chirayu Cancer Hospital
state: MP
city: Bhubaneswar
country: India
facility: Sparsh Hospitals and Critical Care
state: Odisa
city: Jaipur
country: India
facility: SMS Medical College & Hospital
state: Rajasthan
city: Chandigarh
country: India
facility: Nehru Hospital & Post Graduate Institute of Medical Education
Study officials:
affiliation: Cliantha Research India
name: Devesh Verma, PhD
role: STUDY_DIRECTOR
References: