Locally Advanced Non Small Cell Lung Cancer (NSCLC)Phase 1NCT01118676
Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
A Phase 1 study testing cilengitide, radiochemotherapy in people with Locally Advanced Non Small Cell Lung Cancer (NSCLC), run by Institut Claudius Regaud at 2 sites in France.
Trial summary
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up. Eligible patients are included according to a standard 3+3 design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- cilengitide, radiochemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2010to Apr 2015
- Phase
- Phase 1
- 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 proven non small cell lung cancer
- Inoperable tage IIIA or IIIB non small cell lung cancer
- Age ≥ 18 years
- PerfLife expectancy ≥6 months
- Hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
- Hepatic function: Bilirubin within normal limits et AST and ALT ≤ 2 times the upper limit of normal (ULN).
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- Renal function: Creatinine ≤ 1.5 times ULN.
- Absence of cardiac insufficiency, absence of unstable angina, absence of arrythmia
- Patient has health insurance coverage.
- Signed informed consent.
Who cannot join
- Patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
- Uncontrolled hypertension
- Uncontrolled bleeding within the last 3 months.
- Patients under anti-coagulation with anti-vitamin K or therapeutic dose heparin ; low-molecular heparins for prophylaxis are permitted and are not considered an exclusion criterion.
- Presence of cerebral metastases.
- Participation in a clinical trial within the last 8 weeks.
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- Any other specific concomitant anti-tumor treatment (such as chemotherapy, radiotherapy …).
- Patients with a history of myocardial infarction or a cerebral vascular accident within the last 12 months.
- Continued use of aspirin (>325mg/day)
- Major surgery whiting the last 28 days or planned.
- Major non-healing wound, ulcer
- Pregnant or breastfeeding women cannot participate in this trial. Women of reproductive potential must have a negative pregnancy test (blood) within 72 hours before the start of treatment.
- Men and women of reproductive potential must use an efficient contraceptive method when entering the trial and until one months after the end of treatment.
- History of a thrombo-embolic or hemorrhagic event.
- Patients put under tutelage.
- Patients not able to follow the procedures visits, exams foreseen by the trial.
- Any other severe medical or psychiatric condition or biological anomaly - acute or chronic - that, in the investigator's opinion - may render the inclusion of the patient inappropriate.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Toulouse Larrey
Toulouse, 31000
Institut Claudius Regaud
Toulouse, 31000
About this study
Official title: Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.
Eligible patients are included according to a standard 3+3 design.
Read more
Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).
Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.
The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).
After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.
The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.
- Being tested
- cilengitide, radiochemotherapy
- Keywords
- locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy
- 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.
cilengitide, radiochemotherapyDrug
Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy)as continuous infusion.
The dose levels investigated will be applied to the continuous administration of cilengitide(a maximum of 4 dose levels : 12, 18, 27 et 40 mg /hour).
After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cilengitide with standard radiochemotherapy | Experimental | Cilengitide (4 dose levels are defined :12, 18, 27 et 40 mg /hour) concomitant with radiotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction) and cisplatin and vinorelbine based chemotherapy. Receives: Drug: cilengitide, radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy
Measured: at the end of the trial
Secondary outcomes (5)
To determine the rate of objective response according to RECIST and pathological response.
Measured: at the end of the trial
To determine the survival free of metastases and the survival without local relapse at one year.
Measured: at the end of the trial
To determine the overall survival
Measured: at the end of the trial
To determine the toxicity of the combination of radiochemotherapy and continuous infusion cilengitide as well as the toxicity of the combination of chemotherapy and twice weekly cilengitide.
Measured: at the end of the trial
Ancillary studies will be undertaken to determine factors predictive of response to treatment and to characterize the anti-angiogenic effect of Cilengitide.
Measured: at the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Elizabeth COHEN-JONATHAN MOYAL, Pr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118676
- Sponsor's protocol ID
- 07 POUM 01
- Status last verified
- Apr 2026
- First submitted
- 5 May 2010
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Massabeau C, Khalifa J, Filleron T, Modesto A, Bigay-Game L, Plat G, Dierickx L, Aziza R, Rouquette I, Gomez-Roca C, Mounier M, Delord JP, Toulas C, Olivier P, Chatelut E, Mazieres J, Cohen-Jonathan Moyal E. Continuous Infusion of Cilengitide Plus Chemoradiotherapy for Patients With Stage III Non-Small-cell Lung Cancer: A Phase I Study. Clin Lung Cancer. 2018 May;19(3):e277-e285. doi: 10.1016/j.cllc.2017.11.002. Epub 2017 Nov 21.
PubMed 29221762
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01118676
- Acronym / sponsor ID
- 07 POUM 01
- Keywords
- locally advanced non small cell lung cancer (NSCLC), locally advanced, Phase I, Cilengitide, concomitant radiochemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Mar 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 May 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.
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.
Eligible patients are included according to a standard 3+3 design.
Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).
Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.
The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).
After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.
The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilengitide with standard radiochemotherapy | Experimental | Drug: cilengitide, radiochemotherapyCilengitide (4 dose levels are defined :12, 18, 27 et 40 mg /hour) concomitant with radiotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction) and cisplatin and vinorelbine based chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven non small cell lung cancer
- Inoperable tage IIIA or IIIB non small cell lung cancer
- Age ≥ 18 years
- PerfLife expectancy ≥6 months
- Hematological function : neutrophils ≥1500/mm3 and platelets ≥ 100000/mm3
Key exclusion criteria (17 listed)
- Patients previously treated for a malignancy by means of chemotherapy, radiotherapy or surgery.
- Uncontrolled hypertension
- Uncontrolled bleeding within the last 3 months.
- Patients under anti-coagulation with anti-vitamin K or therapeutic dose heparin ; low-molecular heparins for prophylaxis are permitted and are not considered an exclusion criterion.
- Presence of cerebral metastases.
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 |
|---|---|---|
| cilengitide, radiochemotherapyCilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy)as continuous infusion. The dose levels investigated will be applied to the continuous administration of cilengitide(a maximum of 4 dose levels : 12, 18, 27 et 40 mg /hour). After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy. | Drug | Cilengitide with standard radiochemotherapy |
Primary outcome
To determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy
Time frame: at the end of the trial
5 secondary outcomes
To determine the rate of objective response according to RECIST and pathological response.
Time frame: at the end of the trial
To determine the survival free of metastases and the survival without local relapse at one year.
Time frame: at the end of the trial
To determine the overall survival
Time frame: at the end of the trial
To determine the toxicity of the combination of radiochemotherapy and continuous infusion cilengitide as well as the toxicity of the combination of chemotherapy and twice weekly cilengitide.
Time frame: at the end of the trial
Ancillary studies will be undertaken to determine factors predictive of response to treatment and to characterize the anti-angiogenic effect of Cilengitide.
Time frame: at the end of the trial
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 14 Apr 2026.
- Results publication: PubMed 29221762Massabeau C, Khalifa J, Filleron T, Modesto A, Bigay-Game L, Plat G, Dierickx L, Aziza R, Rouquette I, Gomez-Roca C, Mounier M, Delord JP, Toulas C, Olivier P, Chatelut E, Mazieres J, Cohen-Jonathan Moyal E. Continuous Infusion of Cilengitide Plus Chemoradiotherapy for Patients With Stage III Non-Small-cell Lung Cancer: A Phase I Study. Clin Lung Cancer. 2018 May;19(3):e277-e285. doi: 10.1016/j.cllc.2017.11.002. Epub 2017 Nov 21.
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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.
Elizabeth COHEN-JONATHAN MOYAL, Pr principal investigator
Institut Claudius Regaud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cilengitide, radiochemotherapy in people with Locally Advanced Non Small Cell Lung Cancer (NSCLC), run by Institut Claudius Regaud at 2 sites in France.
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 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 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 determine the Maximum Tolerated dose (MTD) of Cilengitide administered as continuous infusion during standard radiochemotherapy (time frame: at the end of the trial). 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 NCT01118676, which also lists 1 linked publication.
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 14 Apr 2026.