Trial Outcomes & Findings for Pembrolizumab in Elderly Patients With Advanced Lung Cancer (NCT NCT03293680)
NCT ID: NCT03293680
Last Updated: 2024-10-23
Results Overview
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.
COMPLETED
PHASE2
83 participants
From the date of inclusion of the first patient to until end of follow up, up to 36 months.
2024-10-23
Participant Flow
A total of 83 patients were recruited between January 2017 and November 2019 and 82 patients received treatment. Of these, 74 patients were finally analysed since eight were inclusion errors.
Participant milestones
| Measure |
Pembrolizumab Arm
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Pembrolizumab Arm
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Did not meet inclusion criteria
|
8
|
Baseline Characteristics
Pembrolizumab in Elderly Patients With Advanced Lung Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Age, Continuous
|
78.1 years
STANDARD_DEVIATION 5.50 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
74 participants
n=93 Participants
|
|
Histology
Adenocarcinoma
|
32 Participants
n=93 Participants
|
|
Histology
Squamous
|
33 Participants
n=93 Participants
|
|
Histology
Large cell carcinoma
|
2 Participants
n=93 Participants
|
|
Histology
Aden squamous
|
1 Participants
n=93 Participants
|
|
Histology
Not otherwise specified / Undifferentiated
|
6 Participants
n=93 Participants
|
|
Current cancer stage
IIIB
|
6 Participants
n=93 Participants
|
|
Current cancer stage
IV
|
68 Participants
n=93 Participants
|
|
Previous antineoplastic treatments
Radiotherapy
|
24 participants
n=93 Participants
|
|
Previous antineoplastic treatments
Surgery
|
9 participants
n=93 Participants
|
|
Previous antineoplastic treatments
Adjuvant chemotherapy
|
6 participants
n=93 Participants
|
|
Previous antineoplastic treatments
Concurrent chemoradiotherapy
|
5 participants
n=93 Participants
|
|
Previous antineoplastic treatments
Neo-adjuvant chemotherapy
|
2 participants
n=93 Participants
|
|
Previous antineoplastic treatments
No therapy
|
28 participants
n=93 Participants
|
|
PD-L1
1-19%
|
16 Participants
n=93 Participants
|
|
PD-L1
20-49%
|
23 Participants
n=93 Participants
|
|
PD-L1
≥50%
|
35 Participants
n=93 Participants
|
|
ECOG performance Status at diagnosis
ECOG 0
|
18 Participants
n=93 Participants
|
|
ECOG performance Status at diagnosis
ECOG 1
|
56 Participants
n=93 Participants
|
|
Smoking history
Never (≤100 cigarettes/lifetime)
|
11 Participants
n=93 Participants
|
|
Smoking history
Former smoker (≥1 year)
|
51 Participants
n=93 Participants
|
|
Smoking history
Current smoker
|
12 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the date of inclusion of the first patient to until end of follow up, up to 36 months.Population: We performed the analyses on the intention-to-treat (ITT) population.
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.
Outcome measures
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Overall Survival
|
19.2 Months
Interval 11.3 to 25.5
|
SECONDARY outcome
Timeframe: Beginning of cycle 1 (week 1) and beginning of cycle 18 (week 54) (each cycle is 3 weeks)Population: Intention to treat population
To evaluate changes in health-related quality of life in responder and non-responder patients older than 70 years with advanced non-small cell lung cancer. QLQ-C30 Quality of Life Questionnaire. The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of multi-item scales and single items. All EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom- atology
Outcome measures
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Changes in Health-related Quality of Life With Lung Cancer Symptom Scale
At the beginning of the first cycle
|
66.7 units on a scale
Interval 16.7 to 100.0
|
|
Changes in Health-related Quality of Life With Lung Cancer Symptom Scale
At the beginning of the eighteenth cycle
|
92.3 units on a scale
Interval 72.3 to 100.0
|
SECONDARY outcome
Timeframe: 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)Population: Intention to treat population
To evaluate the impact on functional geriatric assessments of patients older than 70 years with advanced non-small cell lung cancer. The Barthel Index assesses activities in two major categories: Personal care and mobility. The personal care items include tasks such as drinking from a cup, dressing, grooming, bathing, and bowel and bladder continence. The scoring is as follows: scores of 0-20 indicate "total" dependency. scores of 21-60 indicate "severe" dependency. scores of 61-90 indicate "moderate" dependency. scores of 91-99 indicate "slight" dependency, score of 100 indicate independent.
Outcome measures
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 18
|
97 units on a scale
Interval 90.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 10
|
100 units on a scale
Interval 75.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 1
|
100 units on a scale
Interval 50.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 4
|
100 units on a scale
Interval 76.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 7
|
100 units on a scale
Interval 65.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 13
|
100 units on a scale
Interval 70.0 to 100.0
|
|
Impact on Functional Assessments Measured With Barthel Scale
At the beginning of Cycle 16
|
100 units on a scale
Interval 58.0 to 100.0
|
SECONDARY outcome
Timeframe: From the inclusion date in the study until first progression or end of follow up, up to 36 monthsPopulation: It is performed the analyses on the intention-to-treat (ITT) population.
To describe Progression-free Survival (PFS), according to RECIST criteria v. 1.1 of the first-line treatment with pembrolizumab (MK-3475) in elderly patients with advanced NSCLC. PFS defined as the length of time from the date of randomization to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Progression-free Survival (PFS)
|
6.1 Months
Interval 4.6 to 8.6
|
SECONDARY outcome
Timeframe: From the date of inclusion of the first patient until two years follow up visit, up to 24 monthsPopulation: Intention to treat population
To evaluate the overall survival percentage of the patients included at two years
Outcome measures
| Measure |
Pembrolizumab Arm
n=74 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Overall Survival Rate at 2 Years.
|
40.2 percentage of participants
Interval 28.6 to 51.5
|
SECONDARY outcome
Timeframe: From the initiation of treatment until end of follow up, up to 36 monthsPopulation: It is performed the analyses on the intention-to-treat (ITT) population.
Defined as the length of time from the date of the start of the treatment that patients diagnosed with the disease and PD¨-L1 under 50% are still alive.
Outcome measures
| Measure |
Pembrolizumab Arm
n=39 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
OS for Patients With a PD-L1 Under 50%
|
16.5 Months
Interval 6.8 to 24.6
|
SECONDARY outcome
Timeframe: From the initiation of treatment until end of follow up, up to 36 monthsPopulation: It is performed the analyses on the intention-to-treat (ITT) population.
Defined as the length of time from the start of the treatment that patients diagnosed with the disease and PD-L1 greater than or equal to 50% are still alive.
Outcome measures
| Measure |
Pembrolizumab Arm
n=35 Participants
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
OS for Patients With a PD-L1 Greater Than or Equal to 50%
|
23.3 Months
Interval 14.8 to 36.0
|
Adverse Events
Pembrolizumab Arm
Serious adverse events
| Measure |
Pembrolizumab Arm
n=74 participants at risk
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression disease
|
48.6%
36/74 • Number of events 36 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
General disorders
Other causes of death
|
13.5%
10/74 • Number of events 10 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
Other adverse events
| Measure |
Pembrolizumab Arm
n=74 participants at risk
1 group, Pembrolizumab (MK-3475) 200 mg, every 3 weeks
Pembrolizumab: Pembrolizumab (MK-3475) 200 mg, every 3 weeks
|
|---|---|
|
Investigations
Platelet count decreased
|
8.1%
6/74 • Number of events 6 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Investigations
Increased creatinine level
|
6.8%
5/74 • Number of events 5 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
4/74 • Number of events 4 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
General disorders
Fatigue
|
31.1%
23/74 • Number of events 23 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Gastrointestinal disorders
Diarrhoea
|
18.9%
14/74 • Number of events 14 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.1%
6/74 • Number of events 6 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.2%
12/74 • Number of events 12 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.7%
19/74 • Number of events 19 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.9%
11/74 • Number of events 11 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Endocrine disorders
Hyperthyroidism
|
12.2%
9/74 • Number of events 9 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Hypothyroidism
|
9.5%
7/74 • Number of events 7 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Anorexia
|
16.2%
12/74 • Number of events 12 • 36 months
The severity of AE will be determined using CTCAE version 4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place