A Phase 2 interventional study of BIO-11006 plus standard of care and Standard of Care in Non Small Cell Lung Cancer Stage IIIB, sponsored by BioMarck Pharmaceuticals, Ltd.. Completed at 11 sites in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by BioMarck Pharmaceuticals, Ltd. · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.
Drug: BIO-11006 plus 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
BIO-11006 is administered 125mg BID plus standard of care.
Also known as: Active drug plus standard of care
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
Also known as: Active comparator
Progression-free survival
Survival period of patients in both arms of the study is measured in absence of tumor progression.
Time frame: 12 months
Maintenance of body weight
Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.
Time frame: 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.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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BioMarck Pharmaceuticals, Ltd.