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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study of BT02 in Treating Patients With Advanced Lung Cancer

NCT07110363

Advanced Malignant Solid Tumor Advanced Lung Cancer Non-Small Cell Lung Cancer +1 more

NOT_YET_RECRUITING PHASE1

Efficacy and Safety of BI 2536 in Advanced or Metastatic Non Small Cell Lung Cancer

NCT00376623

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE2

BI 2536 Second Line Monotherapy in SCLC

NCT00412880

Carcinoma, Small Cell

COMPLETED PHASE2

Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer

NCT03520686

Non Small Cell Lung Cancer

ACTIVE_NOT_RECRUITING PHASE3

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT07111520

Non-small Cell Lung Cancer

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer Stage IIIB

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIO-11006 plus standard of care

Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months.

Group Type EXPERIMENTAL

BIO-11006 plus standard of care

Intervention Type DRUG

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

Standard of Care

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

Group Type EXPERIMENTAL

Standard of Care

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIO-11006 plus standard of care

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

Intervention Type DRUG

Standard of Care

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active drug plus standard of care Active comparator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No