TheranosticTrials.org

Clinical Trial · NCT01221675

TF2- Small Cell Lung Cancer Radio Immunotherapy

Overview

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)

Sponsor

Unknown Organization

Phase

Phase 1/2

ClinicalTrials.gov

NCT01221675

Drug / Compound

IMP-288

Isotope(s):
Target(s):
  • CEA
Ligand Class: Peptides
Chelator: DOTA

IMP-288

Isotope(s):
Target(s):
  • CEA
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Minimum life expectancy of 3 months
  • At least one abnormal focus by FDG-PET
  • • 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
  • Positive CEA on immunohistology or plasma CEA ≥ 10 ng/mL
  • Women of child-bearing potential must have a negative pregnancy test.
  • At least 4-weeks after the previous treatment and have recovered from previous radio- or chemotherapy
  • At least one measurable lesion by CT
  • 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)
  • Karnofsky performance status ≥ 60 or ECOG performance status 0-2Karnofsky
  • Imaging studies must be performed within 1-4 weeks before PRAIT study to document extent of disease

Exclusion

  • Poor renal function (creatinine level \> 2.5 maximum normal level)
  • Presence of anti-antibody reactivity
  • Severe disorders of hemostasis or anticoagulant treatment cure
  • Extensive irradiation to more than 25% of their red marrow
  • Treatment with any investigational drug within 30 days before planned PRAIT and during the study
  • Poor hepatic function (total bilirubin level \> 30 mmol/l, transaminases \> 2.5 maximum normal level)
  • Uncontrolled diabetes
  • Any serious active disease or comorbid medical condition (according to the investigator's decision and information provided in the IDB)
  • External radiation to specific organs or areas at the maximum tolerated level
  • Known HIV or hepatitis
  • Platelets \< 100 G/l
  • EGFR gene mutation in tumor (only for NSCLC)
  • Bone marrow involvement to more than 25%
  • Febrile aplasia during a previous chemotherapy
  • Neutrophils \< 1.5 G/l
  • 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.
  • Known hypersensitivity to murine antibodies or proteins
  • 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.
  • Male patient refusing effective contraception for a minimum of 12 months after treatment.