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
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.
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