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Small Cell Lung CancerPhase 1/2NCT01221675

TF2- Small Cell Lung Cancer Radio Immunotherapy

A Phase 1/2 study testing Antibody TF2, IMP-288-Lutetium and IMP-288-Indium in people with Small Cell Lung Cancer and CEA-expressing Non Small Cell Lung Carcinoma (NSCLC), run by Centre René Gauducheau at 6 sites in France.

Completed

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

Official record
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Trial summary

Lung cancer is currently the leading cause of cancer death in both men and women in Europe, with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients indicates that the current recommended regimens are falling short. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Antibody TF2, IMP-288-Lutetium and IMP-288-Indium
Type of treatment
Surgery or procedure
How many people
18 participants
Where
6 sitesFrance
Study dates
Jun 2011to Apr 2016
Phase
Phase 1/2
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

  • Patients with histologic diagnosis of SCLC who are in partial response or who have failed at least two lines of standard radiation and/or chemotherapy. Outside formal contra-indication, patients must have received at least one prior platinum-based chemotherapy.
  • or
  • Patients with histologic diagnosis of NSCLC (without activating mutation of EGFR gene) who have failed at least one line of chemotherapy (platinum in combination with a third generation drug or combination of 2 third generation drug +/-bevacizumab in case of predominance of non-squamous tumor)
  • Age ≥ 18 years
  • At least 4-weeks after the previous treatment and have recovered from previous radio- or chemotherapy
  • Women of child-bearing potential must have a negative pregnancy test.
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  • Karnofsky performance status ≥ 60 or ECOG performance status 0-2Karnofsky
  • Minimum life expectancy of 3 months
  • Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL
  • At least one measurable lesion by CT
  • At least one abnormal focus by FDG-PET
  • Imaging studies must be performed within 1-4 weeks before PRAIT study to document extent of disease
  • Signed informed consent form.

Who cannot join

  • Pregnant or lactating woman. Women of child-bearing potential will be asked to practice adequate means of birth control for a minimum of 12 months after treatment.
  • Male patient refusing effective contraception for a minimum of 12 months after treatment.
  • Brain metastases but patients with brain metastases controlled after treatment by Surgery or radiotherapy since more than 4 weeks are eligibles for the study. An treatment by associated corticotherapy is authorized for these patients.
  • Known HIV or hepatitis
  • Any serious active disease or comorbid medical condition (according to the investigator's decision and information provided in the IDB)
  • Severe disorders of hemostasis or anticoagulant treatment cure
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  • Extensive irradiation to more than 25% of their red marrow
  • Bone marrow involvement to more than 25%
  • External radiation to specific organs or areas at the maximum tolerated level
  • EGFR gene mutation in tumor (only for NSCLC)
  • Febrile aplasia during a previous chemotherapy
  • Neutrophils < 1.5 G/l
  • Platelets < 100 G/l
  • Uncontrolled diabetes
  • Poor renal function (creatinine level > 2.5 maximum normal level)
  • Poor hepatic function (total bilirubin level > 30 mmol/l, transaminases > 2.5 maximum normal level)
  • Treatment with any investigational drug within 30 days before planned PRAIT and during the study
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma,
  • Presence of anti-antibody reactivity
  • Known hypersensitivity to murine antibodies or proteins
  • Adult patient unable to give informed consent because of intellectual impairment.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHU d'Angers

    Angers, 49100

  • CHU

    Brest, 29000

  • Centre Jean Perrin

    Clermont-Ferrand

  • Hôpital La tronche

    Grenoble, 38000

  • Hotel Dieu

    Nantes, 44093

  • Centre René Gauducheau

    Saint-Herblain, 44805

Other trials in France

About this study

Official title: Prospective Multicentric Optimization and Phase I/II Study of Pretargeted Radioimmunotherapy (PRAIT) Using Anti-CEA x Anti-HSG TF2 Bispecific Antibody (bsMAb) and 177Lu-IMP-288 Peptide in Patients With CEA-expressing Small Cell Lung Carcinoma (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

Lung cancer is currently the leading cause of cancer death in both men and women in Europe, with an estimated 250000 new cases diagnosed in 2005. The continued poor outcome of patients indicates that the current recommended regimens are falling short. In addition, many of the commonly used chemotherapy agents are associated with severe nonhematologic toxicities that are often cumulative and nonreversible and impair quality of life in this essentially palliative setting. Therefore, agents with novel mechanisms of action and superior safety profiles need to be investigated. More than 50% of lung cancer shows carcinoembryonic antigen (CEA) expression and anti-CEA radioimmunotherapy (RAIT) could be used. The investigators group showed that pretargeted RAIT (PRAIT) using bispecific antibody (bsMAb) can deliver a higher radiation dose to a tumor than a directly radiolabeled anti-CEA antibody, and shows improved anti-tumor efficacy. This clinical trial is designed to assess PRAIT using an entirely new recombinant anti-CEA bsMAb and a 177Lu-labeled peptide for the treatment of CEA-expressing small cell lung cancers (SCLC) or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

Read the detailed description

The purpose of this open-label prospective optimization and phase I/II clinical trial is to examine the safety, optimal dose, targeting, dosimetry and efficacy of PRAIT using the humanized anti-CEA x anti-HSG bsMAb TF2 and the 177Lu-IMP-288 peptide pretargeted in patients with CEA-positive SCLC or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

This study has 2 parts: Study plan I (Optimization study) and Study plan II (Escalating activity phase I/II study).

The Study plan I is designed to optimize the pretargeting procedure using blood pharmacokinetics (Pk) and dosimetry in 9 patients receiving escalating doses of TF2 followed 2 to 4 days later by 1.1 GBq/m2 of 177Lu-IMP-288.

The study plan II is designed to determined MTD of 177Lu-IMP-288 using dosimetry and toxicity data in a phase I/II study performed in patients receiving optimal dose of TF2 bsMAb (determined in study plan I) followed 2 to 4 days by escalating activity of 177Lu-IMP-288.

A pre-therapy imaging study (using TF2 followed 2 to 4 days later by 185 MBq of 111In-IMP-288) is performed in the two study plans to qualify a patient for treatment with the subsequent therapy dose.

Being tested
Antibody TF2, IMP-288-Lutetium, IMP-288-Indium
Keywords
Small Cell Lung Cancer or CEA-expressing Non Small Cell Lung Carcinoma (NSCLC), Radio Immunotherapy, Lutetium, patient ≥ 18 years of age with CEA-positive SCLC in partial response, or who failed at least two lines of standard radiation and/or chemotherapy, or Patients with histologic diagnosis of NSCLC
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • Antibody TF2Drug

    preciblage with an antibody

  • IMP-288-LutetiumRadiation

    Internal Radiation

  • IMP-288-IndiumRadiation

    Imaging

What is being measured

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

  1. Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.

  2. Primary endpoint of study plan II • the maximum tolerated dose (MTD) for the TF2-pretargeted 177Lu-IMP-288 under optimal pretargeting conditions.

Timeline

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

  1. First posted15 Oct 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221675
Sponsor's protocol ID
BRD 08/9-O
Status last verified
Apr 2016
First submitted
11 Oct 2010
Last updated
31 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bodet-Milin C, Ferrer L, Rauscher A, Masson D, Rbah-Vidal L, Faivre-Chauvet A, Cerato E, Rousseau C, Hureaux J, Couturier O, Salaun PY, Goldenberg DM, Sharkey RM, Kraeber-Bodere F, Barbet J. Pharmacokinetics and Dosimetry Studies for Optimization of Pretargeted Radioimmunotherapy in CEA-Expressing Advanced Lung Cancer Patients. Front Med (Lausanne). 2015 Nov 27;2:84. doi: 10.3389/fmed.2015.00084. eCollection 2015.

    PubMed 26640780

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Antibody TF2, IMP-288-Lutetium and IMP-288-Indium in people with Small Cell Lung Cancer and CEA-expressing Non Small Cell Lung Carcinoma (NSCLC), run by Centre René Gauducheau at 6 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 13 inclusion and 21 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 combined 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.

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?

Primary endpoint of study plan I: To determine the optimal TF2 protein dose for pretargeting IMP-288.. The study lists 2 primary outcomes in all. 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 NCT01221675, 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 31 Aug 2016.

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