Non Small Cell Lung CancerPhase 2NVALT12NCT01171170

Paclitaxel-Carboplatin-Bevacizumab +/- Nitroglycerin in Metastatic Non-Squamous-Non-Small Cell Lung Cancer

A Phase 2 study testing carboplatin paclitaxel bevacizumab and Standard treatment plus nitroglycerin in people with Non Small Cell Lung Cancer, run by Dutch Society of Physicians for Pulmonology and Tuberculosis at 8 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: carboplatin paclitaxel bevacizumab and Standard treatment plus nitroglycerin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 223 participants
Where: 8 sitesNetherlands
Study dates: Jan 2011to Aug 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically/cytologically proven stage IV non-squamous NSCLC (according to IASLC staging 7.0)
No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI), Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy > 1 year ago and prior treatment with an EGFR-TKI for patients with an activating EGFR mutation is allowed.
Age ≥ 18 years.
ECOG Performance Status of 0 - 2.
Life expectancy of at least 12 weeks.
Subjects with at least one uni-dimensional(for RECIST) measurable lesion.

Show all 9Show fewer

Adequate bone marrow, liver and renal function.
Adequate non-hormonal contraception for females of childbearing potential during the study and in the 6 months thereafter.
Adequate contraception for male participants (or their partners) during the study and in the 6 months thereafter.

Who cannot join

Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg).
Symptomatic hypotension.
History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery).
History of HIV infection or chronic hepatitis B or C.
Active clinically serious infection

Show all 17Show fewer

Symptomatic metastatic brain or meningeal tumors. Patients with brain metastasis may be included the patient is treated with brain radiotherapy and asymptomatic.
History of organ allograft.
Patients with evidence or history of bleeding diathesis.
Non-healing wound or ulcer.
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry
Radiotherapy within 4 weeks of start of study drug. Palliative radiotherapy for bone lesions is allowed > 14 days of start of chemotherapy. Major surgery within 4 weeks of start of study.
Use of vasodilators (including 5-phosphodiesterase inhibitors, calcium antagonists or nitrates)
Autologous bone marrow transplant or stem cell rescue within 4 months of study
Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Pregnancy or lactation.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Netherlands8 sites

Jeroen Bosch Ziekenhuis
's-Hertogenbosch
VU medisch centrum
Amsterdam
Amphia Ziekenhuis
Breda
Catharina-Ziekenhuis
Eindhoven
Martini Ziekenhuis
Groningen
Maastricht UMC
Maastricht, 6202 AZ
HagaZiekenhuis
The Hague
Isala Klinieken
Zwolle

Other trials in Netherlands

About this study

Official title: A Randomized Phase II Study of Paclitaxel-carboplatin-bevacizumab With or Without Nitroglycerin Patches in Patients With Stage IV Non-squamous-non-small Cell Lung Cancer: NVALT12

This study is designed to assess the effects of adding nitroglycerin (NTG) patches, delivery 25 mg NTG per 24 h, to the standard first line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC), i.e. 4 cycles of carboplatin-paclitaxel-bevacizumab, followed by bevacizumab alone until disease progression. Tumor hypoxia is a common phenomenon in lung cancer; it is a known poor prognostic marker, related to treatment resistance. Pre-clinical studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug resistance. NTG is a NO donating drug. NTG increases tumor blood flow and thereby augments antitumor drug delivery to the tumor.

A randomized phase II has shown an increase in the response rate from 42% to 72%, when NTG patches (25 mg/day, day -2 to +3) were added to vinorelbine/cisplatin in patients with advanced NSCLC. In addition, the time to progression increased from 185 to 327 days.

The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab containing chemotherapy improves progression free survival, response rate and overall survival in patients with metastatic non-squamous NSCLC.

Read the detailed description

Standard treatment for non-small cell lung cancer (NSCLC) consists of platinum-containing chemotherapy. It has been shown that the addition of bevacizumab to standard chemotherapy improves progression-free survival (PFS) and overall survival (OS) in patients with non-squamous NSCLC. There is a need for improved PFS and OS and response rates to chemotherapy are only 25-35%.

Tumor hypoxia is a common phenomenon in lung cancer; it is a known poor prognostic marker, related to treatment resistance. Hypoxia Inducible Factor (HIF) -1α is the major factor regulating the response to hypoxia.

HIF directly activates vascular endothelial growth factor (VEGF) and VEGF-receptor. Bevacizumab interacts with this pathway by blocking VEGF.

Pre-clinical studies have shown that nitric oxide (NO) donating drugs may decrease hypoxia related drug resistance. Nitroglycerin (NTG) is a NO donating drug. NTG increases tumor blood flow and thereby augments antitumor drug delivery to the tumor and inhibits HIF-1α.

Interestingly, it has recently been shown in mouse models that the addition of HIF-1α inhibitors to bevacizumab significantly inhibits tumor growth by inducing apoptosis.

The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab containing chemotherapy improves PFS, response rate and OS in patients with metastatic non-squamous NSCLC.

Conditions: Non Small Cell Lung Cancer
Being tested: carboplatin paclitaxel bevacizumab, Standard treatment plus nitroglycerin
Keywords: non small cell lung cancer, stage IV, nitroglycerin, carboplatin, paclitaxel, bevacizumab
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carboplatin paclitaxel bevacizumabDrug
Also called Taxol, Avastin
paclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression
Standard treatment plus nitroglycerinDrug
Also called Taxol, Avastin
paclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression. Plus nitroglycerin transdermal patches 25 mg per day from day -3 till +2 of First combination cycle till the last bevacizumab monotherapy cycle

Study groups in NCT01171170
Study group	Role	What they receive
carboplatin-paclitaxel-bevacizumab	Active comparator	paclitaxel 200 mg/m2 d1 - carboplatin area under the curve (AUC) 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression Receives: Drug: carboplatin paclitaxel bevacizumab
standard treatment plus nitroglycerin	Experimental	paclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression. Plus nitroglycerin transdermal patches 25 mg per day from day -3 till +2 of First combination cycle till the last bevacizumab monotherapy cycle Receives: Drug: Standard treatment plus nitroglycerin

What is being measured

The primary outcome is the main question the study is designed to answer.

progression free survival
Imaging
Measured: every 6 weeks during chemotherapy

Secondary outcomes (6)

objective response rate
Imaging
Measured: every 6 weeks during chemotherapy
disease control rate
Imaging
Measured: every 6 weeks during chemotherapy
duration of response
Imaging
Measured: every 6 weeks during chemotherapy
safety of the treatment
adverse events, hematology, chemistry, physial examination
Measured: every 3 weeks during chemotherapy
prediction of early response
FDG PET scan (exploratory objective)
Measured: after 3 weeks
decreased hypoxia
FAZA scan (exploratory objective)
Measured: after 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Aug 2020

First posted28 Jul 2010 (estimated)
Study startJan 2011
Primary completionJun 2014
Study completionAug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CancerStudies 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
Masking: None (open label)
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01171170
Sponsor's protocol ID: NVALT12
Acronym: NVALT12
Status last verified: Sep 2020
First submitted: 23 Jul 2010
Last updated: 28 Sep 2020
Results posted: No
Data monitoring committee: No

Publications

Dingemans AM, Groen HJ, Herder GJ, Stigt JA, Smit EF, Bahce I, Burgers JA, van den Borne BE, Biesma B, Vincent A, van der Noort V, Aerts JG; NVALT study group. A randomized phase II study comparing paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV nonsquamous nonsmall-cell lung cancer: NVALT12 (NCT01171170)dagger. Ann Oncol. 2015 Nov;26(11):2286-93. doi: 10.1093/annonc/mdv370. Epub 2015 Sep 7.
PubMed 26347109
de Jong EE, van Elmpt W, Leijenaar RT, Hoekstra OS, Groen HJ, Smit EF, Boellaard R, van der Noort V, Troost EG, Lambin P, Dingemans AC. [18F]FDG PET/CT-based response assessment of stage IV non-small cell lung cancer treated with paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):8-16. doi: 10.1007/s00259-016-3498-y. Epub 2016 Sep 6.
PubMed 27600280
Degens JHRJ, Sanders KJC, de Jong EEC, Groen HJM, Smit EF, Aerts JG, Schols AMWJ, Dingemans AC. The prognostic value of early onset, CT derived loss of muscle and adipose tissue during chemotherapy in metastatic non-small cell lung cancer. Lung Cancer. 2019 Jul;133:130-135. doi: 10.1016/j.lungcan.2019.05.021. Epub 2019 May 20.
PubMed 31200819
de Goeje PL, Poncin M, Bezemer K, Kaijen-Lambers MEH, Groen HJM, Smit EF, Dingemans AC, Kunert A, Hendriks RW, Aerts JGJV. Induction of Peripheral Effector CD8 T-cell Proliferation by Combination of Paclitaxel, Carboplatin, and Bevacizumab in Non-small Cell Lung Cancer Patients. Clin Cancer Res. 2019 Apr 1;25(7):2219-2227. doi: 10.1158/1078-0432.CCR-18-2243. Epub 2019 Jan 14.
PubMed 30642911
de Jong EEC, Hendriks LEL, van Elmpt W, Gietema HA, Hofman PAM, De Ruysscher DKM, Dingemans AC. What you see is (not) what you get: tools for a non-radiologist to evaluate image quality in lung cancer. Lung Cancer. 2018 Sep;123:112-115. doi: 10.1016/j.lungcan.2018.07.014. Epub 2018 Jul 18.
PubMed 30089580

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase II Study of Paclitaxel-carboplatin-bevacizumab With or Without Nitroglycerin Patches in Patients With Stage IV Non-squamous-non-small Cell Lung Cancer: NVALT12
ClinicalTrials.gov ID: NCT01171170
Acronym / sponsor ID: NVALT12 / NVALT12
Conditions: Non Small Cell Lung Cancer
Keywords: non small cell lung cancer, stage IV, nitroglycerin, carboplatin, paclitaxel, bevacizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Dutch Society of Physicians for Pulmonology and TuberculosisUniversity, hospital or other
Study start: Jan 2011 (actual)
Primary completion: Jun 2014 (actual)
Study completion: Aug 2020 (actual)
First posted: 28 Jul 2010 (estimated)
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.

Detailed description

HIF directly activates vascular endothelial growth factor (VEGF) and VEGF-receptor. Bevacizumab interacts with this pathway by blocking VEGF.

Interestingly, it has recently been shown in mouse models that the addition of HIF-1α inhibitors to bevacizumab significantly inhibits tumor growth by inducing apoptosis.

The hypothesis of the present study is that adding NTG transdermal patches to bevacizumab containing chemotherapy improves PFS, response rate and OS in patients with metastatic non-squamous NSCLC.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
carboplatin-paclitaxel-bevacizumab	Active comparator	Drug: carboplatin paclitaxel bevacizumabpaclitaxel 200 mg/m2 d1 - carboplatin area under the curve (AUC) 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression
standard treatment plus nitroglycerin	Experimental	Drug: Standard treatment plus nitroglycerinpaclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression. Plus nitroglycerin transdermal patches 25 mg per day from day -3 till +2 of First combination cycle till the last bevacizumab monotherapy cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Histologically/cytologically proven stage IV non-squamous NSCLC (according to IASLC staging 7.0)
No prior chemotherapy or therapy with systemic anti-tumor therapy (e.g., monoclonal antibody therapy) or prior exposure to agents directed at the HER axis (e.g. epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI), Herceptin). Prior surgery and/or localized palliative irradiation is permitted provided that the irradiated lesion is not the only measurable lesion. Prior adjuvant chemotherapy > 1 year ago and prior treatment with an EGFR-TKI for patients with an activating EGFR mutation is allowed.
Age ≥ 18 years.
ECOG Performance Status of 0 - 2.
Life expectancy of at least 12 weeks.

Key exclusion criteria (17 listed)

Clinically significant (i.e. active) cardiovascular disease: congestive heart failure >NYHA class 2; CVA or myocardial infarction < 6 months prior to study entry; uncontrolled hypertension (blood pressure systolic > 150 mmHg and/or diastolic > 100 mmHg).
Symptomatic hypotension.
History of hemoptysis at least grade 2 (bright red blood of at least 2,5 ml in the last 3 months)
Evidence of tumor invading major blood vessels on imaging (i.e. superior vena cava or pulmonary artery).
History of HIV infection or chronic hepatitis B or C.

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
carboplatin paclitaxel bevacizumabAlso: Taxol, Avastinpaclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression	Drug	carboplatin-paclitaxel-bevacizumab
Standard treatment plus nitroglycerinAlso: Taxol, Avastinpaclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression. Plus nitroglycerin transdermal patches 25 mg per day from day -3 till +2 of First combination cycle till the last bevacizumab monotherapy cycle	Drug	standard treatment plus nitroglycerin

Primary outcome

progression free survival
Time frame: every 6 weeks during chemotherapy
Imaging

6 secondary outcomes

objective response rate
Time frame: every 6 weeks during chemotherapy
disease control rate
Time frame: every 6 weeks during chemotherapy
duration of response
Time frame: every 6 weeks during chemotherapy
safety of the treatment
Time frame: every 3 weeks during chemotherapy
prediction of early response
Time frame: after 3 weeks
decreased hypoxia
Time frame: after 6 weeks

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 28 Sep 2020.
Results publication: PubMed 26347109Dingemans AM, Groen HJ, Herder GJ, Stigt JA, Smit EF, Bahce I, Burgers JA, van den Borne BE, Biesma B, Vincent A, van der Noort V, Aerts JG; NVALT study group. A randomized phase II study comparing paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches in patients with stage IV nonsquamous nonsmall-cell lung cancer: NVALT12 (NCT01171170)dagger. Ann Oncol. 2015 Nov;26(11):2286-93. doi: 10.1093/annonc/mdv370. Epub 2015 Sep 7.
Results publication: PubMed 27600280de Jong EE, van Elmpt W, Leijenaar RT, Hoekstra OS, Groen HJ, Smit EF, Boellaard R, van der Noort V, Troost EG, Lambin P, Dingemans AC. [18F]FDG PET/CT-based response assessment of stage IV non-small cell lung cancer treated with paclitaxel-carboplatin-bevacizumab with or without nitroglycerin patches. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):8-16. doi: 10.1007/s00259-016-3498-y. Epub 2016 Sep 6.
Results publication: PubMed 31200819Degens JHRJ, Sanders KJC, de Jong EEC, Groen HJM, Smit EF, Aerts JG, Schols AMWJ, Dingemans AC. The prognostic value of early onset, CT derived loss of muscle and adipose tissue during chemotherapy in metastatic non-small cell lung cancer. Lung Cancer. 2019 Jul;133:130-135. doi: 10.1016/j.lungcan.2019.05.021. Epub 2019 May 20.
Results publication: PubMed 30642911de Goeje PL, Poncin M, Bezemer K, Kaijen-Lambers MEH, Groen HJM, Smit EF, Dingemans AC, Kunert A, Hendriks RW, Aerts JGJV. Induction of Peripheral Effector CD8 T-cell Proliferation by Combination of Paclitaxel, Carboplatin, and Bevacizumab in Non-small Cell Lung Cancer Patients. Clin Cancer Res. 2019 Apr 1;25(7):2219-2227. doi: 10.1158/1078-0432.CCR-18-2243. Epub 2019 Jan 14.
Derived from this study: PubMed 30089580de Jong EEC, Hendriks LEL, van Elmpt W, Gietema HA, Hofman PAM, De Ruysscher DKM, Dingemans AC. What you see is (not) what you get: tools for a non-radiologist to evaluate image quality in lung cancer. Lung Cancer. 2018 Sep;123:112-115. doi: 10.1016/j.lungcan.2018.07.014. Epub 2018 Jul 18.
Related InfoLink provided by the sponsor.

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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.

Anne-Marie C. Dingemans, MD PhD principal investigator

Maastricht UMC

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 17 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 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Netherlands. 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: every 6 weeks during chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01171170, which also lists 5 linked publications.

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 28 Sep 2020.