EUCTR2016-001252-22-ITActive, not recruitingPhase 1
Pembrolizumab (MK-3475) as maintainance unresectable stage III NSCLC after chemo-radiotherapy (MP-LALC- Maintainance Pembrolizumab in Locally Advanced Lung Cancer). - Pembrolizumab as mantainance therapy in patients with unresectable stage III non small cell lung can
DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO0 sites126 target enrollmentStarted: November 4, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Histologically or cytologically-confirmed diagnosis of non-small cell lung cancer (NSCLC) – any histology
- •-Age 18-75
- •-PS 0-1 ECOG
- •-Stage IIIA-B disease (with staging including mandatory CT-PET scan) according to TNM classification judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists
- •-Adequate pulmonary function tests (compatible with thoracic irradiation at full doses)
- •-Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
Exclusion Criteria
- •1.Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •2.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •3.Has a known history of active Bacillus Tuberculosis (TB)
- •4.Hypersensitivity to pembrolizumab or any of its excipients.
- •5.Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •6.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •7.Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •8.Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or has evidence of interstitial lung disease.
- •9.Has an active infection requiring systemic therapy.
- •10.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •11.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •12.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •13.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •14.Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •15.Has known active Hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or Hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative is detected).
- •16.Has received a live vaccine within 30 days of planned start of study therapy.
Investigators
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