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

NCT03472053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-19

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer Stage IIIB

Interventions

DRUG

BIO-11006 plus standard of care

BIO-11006 is administered 125mg BID plus standard of care.

DRUG

Standard of Care

Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.

Sponsors & Collaborators

  • BioMarck Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Devesh Verma, PhD · Cliantha Research India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03472053 on ClinicalTrials.gov