TF2- Small Cell Lung Cancer Radio Immunotherapy

NCT01221675 | Completed Phase 1

• 1 other identifier: BRD 08/9-O
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

Brief 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. 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)

Conditions

Small Cell Lung Cancer; CEA-expressing Non Small Cell Lung Carcinoma (NSCLC)

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

Outcome Measures

Primary Outcomes (2)

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

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

Interventions

Antibody TF2 DRUG

preciblage with an antibody

IMP-288-Lutetium RADIATION

Internal Radiation

IMP-288-Indium RADIATION

Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre René Gauducheau: lead

Study Sites (6)

CHU d'Angers

Angers, 49100, France

Location

CHU

Brest, 29000, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Hôpital La tronche

Grenoble, 38000, France

Location

Hotel Dieu

Nantes, 44093, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Related Publications (1)

• 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.

  PMID: 26640780 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 15, 2010
• Study Start: June 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-04

Locations

FR (6)