Non-Small Cell Lung Cancer (NSCLC)Phase 4NCT02316327
Open-label Study in Patients With Metastatic NSLC Treated With Cisplatin, Gemcitabine and Bevacizumab
A Phase 4 study testing gemcitabine, cisplatin and bevacizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- gemcitabine, cisplatin and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Oct 2016
- Phase
- Phase 4
- 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
- Give the written informed consent to participate in the trial before carrying out any specific study procedure.
- Histological or cytological non microcytic lung cancer (NMLC) and non squamous advanced locally or metastatic (IIIB/IV) lung cancer confirmation
- Capability to take on the obligations with study protocol requirements.
- Patients 18 years old.
- ECOG functional status 0 or 1.
- At least a measurable lung lesion with conventional TAC (i.e. ≥ 1cm) in at least one dimension its RECIST criteria (v.1.1) which has not been irradiated.
Show all 10Show fewer
- Appropriate bone marrow function.
- Appropriate hepatic function.
- 10. International normalized ratio (INR) ≤ 1.5 and activate partial thromboplastin time (aPTT) ≤ 1.5 x UNL 7 days previous to the first study drug administration, unless patients have been used prophylactic anticoagulant treatment 11. Patients with brain metastasis which had been treated and also asymptomatic , they are eligible to participate in the study.
- 12. Female patients cannot be pregnant nor lactating. 13. Male fertile patients have to use a high effective method of contraception.
Who cannot join
- Previous treatment with systemic chemotherapy for advance NMLC
- Non microcytic- microcytic mix histology or adeno-squamous mix carcinomas with a predominant squamous component
- Hemoptysis history ≥ grade 2 (defined as at least 2.5 ml of bright red blood) in a period of 3 months prior to receive the study drugs
- Surgery (including open biopsy) or significant traumatic injury in a period of 28 day prior to receive the study drugs.
- Minor surgery including a catheter insertion in a period of 24h prior to the first infusion of bevacizumab
- Proof that the tumor can compress or invade a main vessel in image tests
Show all 18Show fewer
- Radiotherapy in any site for any reason in a period of 28 days prior to receive the study drugs. It is permitted palliative radiotherapy to bone lesions .
- Aspirin based medication (> 325 mg/day or clopidogrel > 75mg/day) present or recent (in a period of 10 days from the first bevacizumab infusion). Medication with oral anticoagulants agents or parenteral medication on full doses (e.g. in a therapeutic range) or the use of thrombolytic agents with present and recent therapeutic intentions (in a period of 10 days prior to the first bevacizumab infusion). The prophylactic medication with anticoagulants is permitted
- History or evidence of inheritance bleeding diathesis or coagulopathy with bleeding risk
- Active gastrointestinal bleeding
- Inadequate controlled hypertension .
- Cardiovascular disease .
- Wounds that do not heal, active peptide ulcer or non treated bone fractures.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 6 months prior to receive the study drugs
- Known hypersensitivity to bevacizumab, cisplatin or gemcitabine or any of its excipients
- Important known hypersensitivity to iodated contrast agents
- Another neoplastic disease other than NMLC in a period of 5 years prior to receive the study drugs with exemption of in situ cervix carcinoma, basal or squamous skin cancer, prostate cancer treated with curative intention and in situ breast ductal carcinoma treated with curative intention
- Proof of any other disease, neurologic or metabolic dysfunction, lab abnormality or physical test that can reasonably make suspect circumstances that would contraindicate the use of a certain investigational or the standard treatment used in this study or that puts the patient into a greater risk to suffer complications related to the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV/II Open-label Study to Evaluate Prompt Response to Treatment With Cisplatin, Gemcitabine and Bevacizumab in Patients With Non-small Lung Cancer.
RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Functional imaging techniques are able to study in vivo physiological processes of angiogenesis. Therefore, dynamic techniques may be more appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is focused on tumor's vasculature normalization. Preliminary studies have demonstrated significant and very early changes in indirect vasculature parameters such as flow, blood volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for selecting patients who are going to benefit from antiangiogenic therapy by an early evaluation of response by means of functional imaging method.
PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive value and early radiologic response or perfusion computed tomography (CT) in patients diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with bevacizumab in combination with chemotherapy.
Read the detailed description
OBJECTIVES
Primary objective:
- To assess early tumour response (at day +7) in terms of blood flow as compared to Objective Response Rate (ORR) in terms of RECIST criteria (CR + PR) at day 42.
Secondary objectives:
- To assess early tumour response (at day +7) in terms of blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42.
- To assess tumour response (at day +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42.
- To assess tumour response (at day +7 and +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to PFS and OS
- Safety profile using NCI-CTC AE (version 4.0).
- To assess the efficacy in the subgroup of adenocarcinoma pts.
Outline:
Patients receive bevacizumab 7.5mg/kg IV, cisplatin 80mg/m2 and gemcitabine 1250 mg/m2 on days 1 and 8 up to 6 cycles of 21 days. Patients without progression may continue maintenance treatment with single-agent bevacizumab 7.5 mg/Kg on day 1 every 21 days.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- gemcitabine, cisplatin and 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.
gemcitabine, cisplatin and bevacizumabDrug
Also called Avastin
Therapeutic
| Study group | Role | What they receive |
|---|---|---|
| gemcitabine, cisplatin and bevacizumab | Experimental | Bevacizumab will be given by I.V infusion at the dose of 7.5 mg/kg on days 1 every 21 days
Cisplatin 80 mg/m2 I.V on day 1
Gemcitabine 1250 mg/m2 I.V on day 1 \& 8
Treatment cycles will be repeated every three weeks up to 6 cycles
Bevacizumab monotherapy as maintenance allowed in non-progressive tumors Receives: Drug: gemcitabine, cisplatin and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate blood supply, blood volume, time to peak flow increase and permeability and relation with the objective response to treatment (RC+RP)
Measured: The results on baseline and day 7 to treatment in terms of blood suply, blood volume, time of peak flow increase and permeability and relation with the objective (RC+RP) at day 42.
Secondary outcomes (4)
To evaluate the response to treatment in terms of blood supply, blood volume and time to peak flow increase and permeability.
Measured: To evaluate at day +42 the response to treatment in terms of blood supply, blood volume and time to peak flow increase and permeability.
To evaluate the blood supply, blood volume, time to peak flow increase, permeability related with PFS and OS.
Measured: To evaluate the blood fluid, blood volume, time to peak flow increase, permeability at baseline visita related with PFS and OS.
To evaluate the response to treatment at day +7 and +42 in terms of blood fluid, blood volume, time to peak flow increase, permeability at baseline visit related with PFS and OS.
Measured: To evaluate the response to treatment at day +7 and +42 in terms the blood fluid, blood volume, time to peak flow increase, permeability at baseline visita related with PFS and OS.
The safety of the treatment following NCI-CTC AE (version 4.0)
Measured: The safety of the treatment following NCI-CTC AE (version 4.0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Noemi Reguart, MD, PhD, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Noemi Reguart, MD, PhD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316327
- Sponsor's protocol ID
- IMPACT
- Other IDs
- 2012-000459-15
- Status last verified
- Oct 2016
- First submitted
- 5 Dec 2014
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
PubMed 17167137Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009 Mar 10;27(8):1227-34. doi: 10.1200/JCO.2007.14.5466. Epub 2009 Feb 2.
PubMed 19188680Tacelli N, Remy-Jardin M, Copin MC, Scherpereel A, Mensier E, Jaillard S, Lafitte JJ, Klotz E, Duhamel A, Remy J. Assessment of non-small cell lung cancer perfusion: pathologic-CT correlation in 15 patients. Radiology. 2010 Dec;257(3):863-71. doi: 10.1148/radiol.10100181. Epub 2010 Sep 15.
PubMed 20843993Fraioli F, Vetere S, Anile M, Venuta F. Computed tomography perfusion: a new method to evaluate response to therapy in lung cancer. J Thorac Oncol. 2011 Sep;6(9):1599-600. doi: 10.1097/JTO.0b013e3182259207. No abstract available.
PubMed 21849856Tacelli N, Santangelo T, Scherpereel A, Duhamel A, Deken V, Klotz E, Cortot A, Lafitte JJ, Wallyn F, Remy J, Remy-Jardin M. Perfusion CT allows prediction of therapy response in non-small cell lung cancer treated with conventional and anti-angiogenic chemotherapy. Eur Radiol. 2013 Aug;23(8):2127-36. doi: 10.1007/s00330-013-2821-2. Epub 2013 Apr 4.
PubMed 23553586Yuan X, Zhang J, Quan C, Cao J, Ao G, Tian Y, Li H. Differentiation of malignant and benign pulmonary nodules with first-pass dual-input perfusion CT. Eur Radiol. 2013 Sep;23(9):2469-74. doi: 10.1007/s00330-013-2842-x. Epub 2013 Jun 22.
PubMed 23793548
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV/II Open-label Study to Evaluate Prompt Response to Treatment With Cisplatin, Gemcitabine and Bevacizumab in Patients With Non-small Lung Cancer.
- ClinicalTrials.gov ID
- NCT02316327
- Acronym / sponsor ID
- IMPACT
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Dec 2014 (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.
RATIONALE: Classically the evaluation of response in lung cancer has been based in comparing pre \& post treatment tumour volume by means of studying changes in the diameter of the selected target lesions by RECIST. The introduction of new targeted drugs creates the need of a different response assessment. Functional imaging techniques are able to study in vivo physiological processes of angiogenesis. Therefore, dynamic techniques may be more appropriate for assessing response to antiangiogenic drugs, whose mechanism of action is focused on tumor's vasculature normalization. Preliminary studies have demonstrated significant and very early changes in indirect vasculature parameters such as flow, blood volume and tumor perfusion with vascular-targeting agents. These techniques may be useful for selecting patients who are going to benefit from antiangiogenic therapy by an early evaluation of response by means of functional imaging method.
PURPOSE: IMPACT is an open-label, single arm phase II/IV study to evaluate the predictive value and early radiologic response or perfusion computed tomography (CT) in patients diagnosed with unresectable advanced, metastatic or recurrent non-squamous NSCLC treated with bevacizumab in combination with chemotherapy.
Detailed description
OBJECTIVES
Primary objective:
- To assess early tumour response (at day +7) in terms of blood flow as compared to Objective Response Rate (ORR) in terms of RECIST criteria (CR + PR) at day 42.
Secondary objectives:
- To assess early tumour response (at day +7) in terms of blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42.
- To assess tumour response (at day +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to ORR (CR + PR) at day 42.
- To assess tumour response (at day +7 and +42) in terms of blood flow, blood volume, mean transit time, enhancement peak, time to the enhancement peak and capillary tumour permeability as compared to PFS and OS
- Safety profile using NCI-CTC AE (version 4.0).
- To assess the efficacy in the subgroup of adenocarcinoma pts.
Outline:
Patients receive bevacizumab 7.5mg/kg IV, cisplatin 80mg/m2 and gemcitabine 1250 mg/m2 on days 1 and 8 up to 6 cycles of 21 days. Patients without progression may continue maintenance treatment with single-agent bevacizumab 7.5 mg/Kg on day 1 every 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gemcitabine, cisplatin and bevacizumab | Experimental | Drug: gemcitabine, cisplatin and bevacizumabBevacizumab will be given by I.V infusion at the dose of 7.5 mg/kg on days 1 every 21 days Cisplatin 80 mg/m2 I.V on day 1 Gemcitabine 1250 mg/m2 I.V on day 1 \& 8 Treatment cycles will be repeated every three weeks up to 6 cycles Bevacizumab monotherapy as maintenance allowed in non-progressive tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Give the written informed consent to participate in the trial before carrying out any specific study procedure.
- Histological or cytological non microcytic lung cancer (NMLC) and non squamous advanced locally or metastatic (IIIB/IV) lung cancer confirmation
- Capability to take on the obligations with study protocol requirements.
- Patients 18 years old.
- ECOG functional status 0 or 1.
Key exclusion criteria (18 listed)
- Previous treatment with systemic chemotherapy for advance NMLC
- Non microcytic- microcytic mix histology or adeno-squamous mix carcinomas with a predominant squamous component
- Hemoptysis history ≥ grade 2 (defined as at least 2.5 ml of bright red blood) in a period of 3 months prior to receive the study drugs
- Surgery (including open biopsy) or significant traumatic injury in a period of 28 day prior to receive the study drugs.
- Minor surgery including a catheter insertion in a period of 24h prior to the first infusion of bevacizumab
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 |
|---|---|---|
| gemcitabine, cisplatin and bevacizumabAlso: AvastinTherapeutic | Drug | gemcitabine, cisplatin and bevacizumab |
Primary outcome
To evaluate blood supply, blood volume, time to peak flow increase and permeability and relation with the objective response to treatment (RC+RP)
Time frame: The results on baseline and day 7 to treatment in terms of blood suply, blood volume, time of peak flow increase and permeability and relation with the objective (RC+RP) at day 42.
4 secondary outcomes
To evaluate the response to treatment in terms of blood supply, blood volume and time to peak flow increase and permeability.
Time frame: To evaluate at day +42 the response to treatment in terms of blood supply, blood volume and time to peak flow increase and permeability.
To evaluate the blood supply, blood volume, time to peak flow increase, permeability related with PFS and OS.
Time frame: To evaluate the blood fluid, blood volume, time to peak flow increase, permeability at baseline visita related with PFS and OS.
To evaluate the response to treatment at day +7 and +42 in terms of blood fluid, blood volume, time to peak flow increase, permeability at baseline visit related with PFS and OS.
Time frame: To evaluate the response to treatment at day +7 and +42 in terms the blood fluid, blood volume, time to peak flow increase, permeability at baseline visita related with PFS and OS.
The safety of the treatment following NCI-CTC AE (version 4.0)
Time frame: The safety of the treatment following NCI-CTC AE (version 4.0)
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 5 Oct 2016.
- Background: PubMed 17167137Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
- Background: PubMed 19188680Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009 Mar 10;27(8):1227-34. doi: 10.1200/JCO.2007.14.5466. Epub 2009 Feb 2.
- Background: PubMed 20843993Tacelli N, Remy-Jardin M, Copin MC, Scherpereel A, Mensier E, Jaillard S, Lafitte JJ, Klotz E, Duhamel A, Remy J. Assessment of non-small cell lung cancer perfusion: pathologic-CT correlation in 15 patients. Radiology. 2010 Dec;257(3):863-71. doi: 10.1148/radiol.10100181. Epub 2010 Sep 15.
- Background: PubMed 21849856Fraioli F, Vetere S, Anile M, Venuta F. Computed tomography perfusion: a new method to evaluate response to therapy in lung cancer. J Thorac Oncol. 2011 Sep;6(9):1599-600. doi: 10.1097/JTO.0b013e3182259207. No abstract available.
- Background: PubMed 23553586Tacelli N, Santangelo T, Scherpereel A, Duhamel A, Deken V, Klotz E, Cortot A, Lafitte JJ, Wallyn F, Remy J, Remy-Jardin M. Perfusion CT allows prediction of therapy response in non-small cell lung cancer treated with conventional and anti-angiogenic chemotherapy. Eur Radiol. 2013 Aug;23(8):2127-36. doi: 10.1007/s00330-013-2821-2. Epub 2013 Apr 4.
- Background: PubMed 23793548Yuan X, Zhang J, Quan C, Cao J, Ao G, Tian Y, Li H. Differentiation of malignant and benign pulmonary nodules with first-pass dual-input perfusion CT. Eur Radiol. 2013 Sep;23(9):2469-74. doi: 10.1007/s00330-013-2842-x. Epub 2013 Jun 22.
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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.
Noemi Reguart, MD, PhD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gemcitabine, cisplatin and bevacizumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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 10 inclusion and 18 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 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate blood supply, blood volume, time to peak flow increase and permeability and relation with the objective response to treatment (RC+RP) (time frame: The results on baseline and day 7 to treatment in terms of blood suply, blood volume, time of peak flow increase and permeability and relation with the objective (RC+RP) at day 42.). 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 NCT02316327, which also lists 6 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 5 Oct 2016.