First line treatment in PD-L1 positive advanced non-small cell lung cancer patients
Conditions
Interventions
Product Name: Pembrolizumab
Product Code: MK-3475
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: PEMBROLIZUMAB
CAS Number: 1374853-91-4
Current Sponsor code
Sponsors
Spanish Lung Cancer Group (SLCG/GECP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically or cytological documented stage IIIB or IV squamous and non-squamous non-small-cell lung cancer previously untreated. - EGFR and ALK have to be wild-type. - The subject must be willing and able to provide written informed consent/assent for the trial. - Patients must be aged >70 years, on day of signing informed consent. - PD-L1 expression = 1% - ECOG 0 - 1 - Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 82
Exclusion criteria
Exclusion criteria: - Is currently participating and receiving study therapy or has participated in a study within 4 weeks of the first dose of treatment. - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose over 10 mg of prednisone or equivalent, or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. - Hypersensitivity to Pembrolizumab or any of its excipients. - Has a known history of active TB (Bacillus Tuberculosis) - Has had any prior anti-cancer therapy for his or her metastatic NSCLC. In the case of patients who have progressed to a metastatic stage after having been treated for early stage NSCLC, chemotherapy or radiation therapy as part of this previous treatment is allowed, provided they have been completed more than three months ago. Patients who received adjuvant or neoadjuvant treatment or both for early stages will be eligible for this trial. - Has had any previous malignancy (except non melanoma skin cancer, and cancer in situ of: bladder, gastric, colon, cervical/dysplasia, melanoma, breast), unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate if they are stable and have no evidence of new or enlarging brain metastases, and are not using steroids at a dose over 10 mg of prednisone or equivalent, for at least 7 days prior to trial treatment - Patient has active autoimmune disease that has required systemic treatment in the past 2 years - Has any geriatric exclusion criteria: advanced dementia (GDS ranking >6), - moderate or severe functional dependence (Barthel Index < 35) or Life expectancy less than one year, due to co-morbidities other than lung cancer. - Evidence of interstitial lung disease. - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. - Has a known history of Human Immunodeficiency Virus, active Hepatitis B or Hepatitis C. - Has an active infection requiring systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy, in terms of overall survival at one year, of first-line treatment with Pembrolizumab (MK-3475) in elderly patients with advanced NSCLC expressing PD-L1.;Primary end point(s): To determine the efficacy, in terms of overall survival at one year, of first-line treatment with Pembrolizumab (MK-3475) in elderly patients with advanced NSCLC expressing PD-L1.;Timepoint(s) of evaluation of this end point: 1 year recruiting patients 2 years of treatment with Pembrolizumab (MK-3475) At least 1 year of follow up;Secondary Objective: To evaluate changes in health-related quality of life in responder and non-responder patients according to the QLQ-C30, the LCSS and the QLQ-ELD14 questionnaires. To evaluate the impact on functional, cognitive and nutritional geriatric assessments of subjects. To describe the Objective Response Rate (ORR), and the Progression-free Survival (PFS), according to RECIST criteria. To assess the median disease-specific survival (DSS) and the Overall Survival rate at 2 years. To describe the safety and tolerability profile of first-line pembrolizumab (MK-3475) in previously untreated elderly patients with advanced NSCLC expressing PD-L1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate changes in health-related quality of life in responder and non-responder patients according to the QLQ-C30, the LCSS and the QLQ-ELD14 questionnaires. To evaluate the impact on functional, cognitive and nutritional geriatric assessments of subjects. To describe the Objective Response Rate (ORR), and the Progression-free Survival (PFS), according to RECIST criteria. To assess the median disease-specific survival (DSS) and the Overall Survival rate at 2 years. To describe the safety and tolerability profile of first-line pembrolizumab (MK-3475) in previously untreated elderly patients with advanced NSCLC expressing PD-L1.;Timepoint(s) of evaluation of this end point: 1 year recruiting patients 2 years of treatment with Pembrolizumab (MK-3475) At least 1 year of follow up | — |
Countries
Spain
Contacts
Public ContactEva Pereira
Spanish Lung Cancer Group (SLCG/GECP)
Outcome results
None listed