Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT04533451 |
Recruitment Status :
Recruiting
First Posted : August 31, 2020
Last Update Posted : January 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Lung Adenocarcinoma Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Adenocarcinoma Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 | Drug: Pembrolizumab Drug: Pemetrexed Drug: Carboplatin Other: Comprehensive Geriatric Assessment Other: Questionnaire Administration Other: Quality-of-Life Assessment | Phase 2 |
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To estimate the adverse event profile of MK-3475 (pembrolizumab) in non-small cell lung cancer patients who are age 70 years of age or older and who are treated with MK-3475 (pembrolizumab) +/- chemotherapy in a first-line setting.
SECONDARY OBJECTIVES:
I. To estimate overall survival. II. To describe patient quality of life during the treatment using the Linear Analogue Self-Assessment (LASA) questionnaire.
III. To explore whether Comprehensive Geriatric Assessment (CGA) -derived risk score is able to predict rates of severe adverse events in older cancer patients who receive MK-3475 (pembrolizumab) or MK-3475 (pembrolizumab) + chemotherapy.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up annually for up to 5 years after registration.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Older Non-Small Cell Lung Cancer Patients (>/= 70 Years of Age) Treated With First-Line MK-3475 (Pembrolizumab)+/- Chemotherapy (Oncologist's/Patient's Choice) |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | August 2023 |
Estimated Study Completion Date : | May 2027 |

Arm | Intervention/treatment |
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Experimental: Group A (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: Pembrolizumab
Given IV Other: Comprehensive Geriatric Assessment Ancillary studies Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies |
Experimental: Group B (pembrolizumab, pemetrexed, carboplatin)
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: Pembrolizumab
Given IV Drug: Pemetrexed Given IV Drug: Carboplatin Given IV Other: Comprehensive Geriatric Assessment Ancillary studies Other: Questionnaire Administration Ancillary studies Other: Quality-of-Life Assessment Ancillary studies |
- Incidence of grade 3 or worse adverse events post registration [ Time Frame: Up to 7 days of last day of treatment ]Assessed by National Cancer Institute Common Terminology Criteria in Adverse Events version 5.0. The proportion of patients experience grade 3 or worse adverse events (AEs) will be summarized by frequency and percentage along with a 95% confidence interval (CI) separately by type of therapy (monotherapy or combination therapy) as well as combining the two cohorts. All other individual AEs will be analyzed in an exploratory and hypothesis generating manner; including and not limited to multi-variate logistic regression models considering the baseline demographics and the presence/absence of the AE.
- Overall survival (OS) [ Time Frame: From study registration to death or the last follow-up whichever occurs first, assessed up to 5 years ]Will be summarized using the Kaplan-Meier estimator, separately by monotherapy or combination therapy as well as by the combined cohort.
- Quality of life (QOL): Linear Analogue Self-Assessment [LASA] questionnaire [ Time Frame: Up to 5 years ]The overall quality of life score (the first question of the Linear Analogue Self-Assessment [LASA] questionnaire) at each time point as well as change from baseline will be summarized by mean (standard deviation), median (range) along with a longitudinal plot. The median quality of life (QOL) change from baseline along with a 95% confidence interval (CI) will be estimated using the Hodges-Lehmann method. The overall quality of life score will be measured on a scale from 0-10, with higher being better.
- Comprehensive geriatric assessment risk score [ Time Frame: At baseline ]The geriatric risk score, measured as low, medium, or high, will be summarized in a 3X2 frequency table with adverse events.

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
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Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:
- MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days or 400 mg IV every 42 days.
- MK-3475 (pembrolizumab) 200 mg IV or 400 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician)
- Patients will be ineligible if they have an autoimmune disorder, are post-organ transplantation, or are receiving ongoing immunosuppression treatment
- Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration
- No planned radiation or other cancer treatment in the 3 months following registration
- No untreated brain metastases. Patients must be off corticosteroids and asymptomatic at registration
- Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)
- Platelet count: >= 100,000/mm^3 (100 x 10^9/L)
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Creatinine >= 30 mL/min* for patients enrolled to pembrolizumab alone and > 45 mL/min for patients enrolled to chemotherapy + pembrolizumab
* Calculated using the Cockcroft-Gault formula
- Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)
- Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04533451
Contact: Aminah Jatoi, MD | 507-266-9160 | jatoi.aminah@mayo.edu |

Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT04533451 |
Other Study ID Numbers: |
A171901 NCI-2020-00544 ( Registry Identifier: NCI Clinical Trial Reporting Program ) UG1CA189823 ( U.S. NIH Grant/Contract ) |
First Posted: | August 31, 2020 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma Adenocarcinoma of Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carboplatin Pembrolizumab Pemetrexed Antineoplastic Agents Antineoplastic Agents, Immunological Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |