A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03472053|
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : May 19, 2020
|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|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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)|
|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|
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
- Progression-free survival [ Time Frame: 12 months ]Survival period of patients in both arms of the study is measured in absence of tumor progression.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472053
|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|
|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|
|Study Director:||Devesh Verma, PhD||Cliantha Research, India|