Pembrolizumab (MK-3475) in elderly patients with non-small cell lung cancer

Phase 1

• Conditions: First line treatment in PD-L1 positive advanced non-small cell lung cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004353-32-ES
• Lead Sponsor: Spanish Lung Cancer Group (SLCG/GECP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-21
• Last Update Posted: 16 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified