Pembrolizumab in Elderly Patients With Advanced Lung Cancer

NCT03293680 | Completed Phase 2 Results

• 1 other identifier: GECP 16/06_PEBEL
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 12

Brief Summary

This is a multi-center phase II trial of intravenous (IV) Pembrolizumab MK-3475 in subjects older than 70 years with advanced Non-small cell Lung Cancer (NSCLC) expressing Programmed death-ligand 1 (PD-L1). 82 patients will be enrolled in this trial to examine the efficacy, the impact on geriatric assessments, the quality of life and the self-reported outcomes.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

  From the date of inclusion of the first patient to until end of follow up, up to 36 months.

Secondary Outcomes (6)

• Changes in Health-related Quality of Life With Lung Cancer Symptom Scale

  Beginning of cycle 1 (week 1) and beginning of cycle 18 (week 54) (each cycle is 3 weeks)

• Impact on Functional Assessments Measured With Barthel Scale

  Beginning of cycle 1 (week 1), beginning of cycle 4 (week 12), beginning of cycle 7 (week 21), beginning of cycle 10 (week 30), beginning of cycle 13 (week 39), beginning of cycle 16 (week 48) and beginning of cycle 18 (week 54) (each cycle is 3 weeks)

• Progression-free Survival (PFS)

  From the inclusion date in the study until first progression or end of follow up, up to 36 months

• Overall Survival Rate at 2 Years.

  From the date of inclusion of the first patient until two years follow up visit, up to 24 months

• OS for Patients With a PD-L1 Under 50%

  From the initiation of treatment until end of follow up, up to 36 months

Study Arms (1)

Pembrolizumab Arm

EXPERIMENTAL

1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab (MK-3475) 200 mg, every 3 weeks

Also known as: KEYTRUDA

Pembrolizumab Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with histological or cytological documented stage III B or IV squamous and non-squamous non-small-cell lung cancer previously untreated.
• Epidermal Growth Factor receptor (EGFR) and Anaplastic lymphoma kinase (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 more than 70 years, on day of signing informed consent.
• Be willing to provide tissue from a newly obtained core or excision biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
• PD-L1 expression ≥ 1%
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
• Screening laboratory values must meet the following criteria (Table 1, see protocol), all screening laboratory tests should be performed within 8 days of treatment initiation.
• 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.

You may not qualify if:

• 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.
• 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.
• Has a known history of active Tuberculosis Bacillus
• Hypersensitivity to Pembrolizumab or any of its excipients.
• 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. All adverse events related to these previous treatments must have recovered (i.e., ≤ Grade 1 or at baseline).
• 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 (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), 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. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• 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 (eg., thyroxin, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Has an active infection requiring systemic therapy.
• 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.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• advanced dementia (GDS ranking \>6)
• moderate or severe functional dependence (Barthel Index \< 35)
• Life expectancy less than one year, due to co-morbidities other than lung cancer.

Sponsors & Collaborators

• Spanish Lung Cancer Group: lead

Study Sites (12)

ICO-Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital Universitario Sta Lucia

Cartagena, Murcia, 30202, Spain

Location

Hospital Lluís Alcanyís

Xàtiva, Valencia, 46800, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Virgen de la Luz

Cuenca, 16002, Spain

Location

Hospital Lucus Agustí

Lugo, 27003, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Dr. Peset

Valencia, 46017, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies
• Lung Cancer Publication

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Age-specific issues for complete the study relative to older cancer patients.

Results Point of Contact

• Title: Eva Pereira
• Organization: Fundación GECP

gecp@gecp.org

+34934302006

Study Officials

• Remei Blanco, PhD

  Hospital de Terrassa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 26, 2017
• Study Start: January 15, 2017
• Primary Completion: April 28, 2023
• Study Completion: July 15, 2023
• Last Updated: October 23, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)