Non Small Cell Lung Cancer Stage IIIBPhase 2NCT03472053
A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
A Phase 2 study of Non Small Cell Lung Cancer Stage IIIB, run by BioMarck Pharmaceuticals, Ltd. at 11 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer Stage IIIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesIndia
- Study dates
- 1 Feb 2018to 30 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are physically able to self administer drug by nebulizer;
- Measurable disease per RECIST Version 1.1;
- Female patients of child bearing age must have a negative pregnancy test;
- ECOG 0-2;
- Written informed consent;
Who cannot join
- Candidates for curative surgery and/or radiation therapy;
- Baseline ANC<2000 cells/mm cube; platelet count <100,000 cells/mm cube
- Creatinine clearance <45 mL/min;
- Billirubin >2 x the upper limit of normal
- Known history of HIV, hepatitis B, hepatitis C or tuberculosis;
- Current pneumonia or idiopathic pulmonary fibrosis;
- Hypersensitivity to test drug, pemetrexed, or carboplatin.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Chirayu Cancer Hospital
Bhopal, Madhya Pradesh, 462030
Sparsh Hospitals and Critical Care
Bhubaneswar, Odisha, 751007
Nehru Hospital & Post Graduate Institute of Medical Education
Chandigarh, 160012
Aadhar Health Institute
Hisar, Haryana, 125005
SMS Medical College & Hospital
Jaipur, Rajasthan, 302016
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Navsanjeevani Hospital
Nashik, Maharashtra, 422002
HCG Manavata Cancer Center
Nashik, Maharashtra, 422004
Vardhman Mahavir Medical College & Hospital
New Delhi, National Capital Territory of Delhi, 110029
Deenanath Mangeshkar Hospital & Research Center
Pune, Maharashtra, 411004
Unique Hospital and Research Institute
Surat, Gujarat, 395002
About this study
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.
Read the detailed description
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
- Non Small Cell Lung Cancer Stage IIIB
- Being tested
- BIO-11006 plus standard of care, Standard of Care
- Keywords
- Lung cancer, non small cell, metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-11006 plus standard of careDrug
Also called Active drug plus standard of care
BIO-11006 is administered 125mg BID plus standard of care.
Standard of CareDrug
Also called Active comparator
Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
| Study group | Role | What they receive |
|---|---|---|
| BIO-11006 plus standard of care | Experimental | Aerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months. Receives: Drug: BIO-11006 plus standard of care |
| Standard of Care | Experimental | Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Survival period of patients in both arms of the study is measured in absence of tumor progression.
Measured: 12 months
Secondary outcomes (2)
Maintenance of body weight
Patient's body weight in kilograms measured at three month and at 12 month to assess possible disease related cachexia.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Feb 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Devesh Verma, PhD, Study director, Cliantha Research India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472053
- Sponsor's protocol ID
- BIO-NSCLC-001
- Status last verified
- May 2020
- First submitted
- 1 Mar 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03472053
- Acronym / sponsor ID
- BIO-NSCLC-001
- Conditions
- Non Small Cell Lung Cancer Stage IIIB
- Keywords
- Lung cancer, non small cell, metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| BIO-11006 plus standard of care | Experimental | Drug: BIO-11006 plus standard of careAerosolized BIO-11006 (125mg BID) plus standard of care (Pemetrexed plus Carboplatin) is administered for three months. |
| Standard of Care | Experimental | Drug: Standard of CarePemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's Formula) is administered every three weeks for three months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are physically able to self administer drug by nebulizer;
- Measurable disease per RECIST Version 1.1;
- Female patients of child bearing age must have a negative pregnancy test;
- ECOG 0-2;
- Written informed consent;
Key exclusion criteria (7 listed)
- Candidates for curative surgery and/or radiation therapy;
- Baseline ANC<2000 cells/mm cube; platelet count <100,000 cells/mm cube
- Creatinine clearance <45 mL/min;
- Billirubin >2 x the upper limit of normal
- Known history of HIV, hepatitis B, hepatitis C or tuberculosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIO-11006 plus standard of careAlso: Active drug plus standard of careBIO-11006 is administered 125mg BID plus standard of care. | Drug | BIO-11006 plus standard of care |
| Standard of CareAlso: Active comparatorPemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months. | Drug | Standard of Care |
Primary outcome
Progression-free survival
Time frame: 12 months
Survival period of patients in both arms of the study is measured in absence of tumor progression.
2 secondary outcomes
Maintenance of body weight
Time frame: 3 and12 months
Treatment emergent adverse effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devesh Verma, PhD study director
Cliantha Research India
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Non Small Cell Lung Cancer Stage IIIB, run by BioMarck Pharmaceuticals, Ltd. at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.