CLINICAL TRIAL

Pembrolizumab for Carcinoma, Non-Small-Cell Lung

Waitlist Available · 18+ · All Sexes · Indianapolis, IN

This study is evaluating whether a drug called pembrolizumab can be used to treat people with cancer who have already had a response to a drug called a PD-1 or PD-L1 inhibitor.

See full description

About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Carcinoma, Non-Small-Cell Lung · Non-Small Cell Lung Carcinoma (NSCLC) · Lung Neoplasms

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pembrolizumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Side Effect Profile for Pembrolizumab + Etoposide

Pembrolizumab + Etoposide
Show all side effects
Neutropenia
54%
Anaemia
45%
Nausea
38%
Alopecia
34%
Decreased appetite
31%
Constipation
29%
Fatigue
27%
Thrombocytopenia
26%
Leukopenia
22%
Diarrhoea
20%
Cough
20%
Asthenia
17%
Dyspnoea
17%
Vomiting
16%
Pyrexia
14%
Dizziness
14%
Headache
13%
Rash
13%
Pruritus
11%
Insomnia
11%
Back pain
11%
Hypothyroidism
10%
Weight decreased
10%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Arthralgia
9%
Oedema peripheral
8%
Alanine aminotransferase increased
8%
Pneumonia
8%
Abdominal pain
7%
Febrile neutropenia
7%
Blood creatinine increased
7%
Upper respiratory tract infection
7%
Hypokalaemia
7%
Hyperthyroidism
6%
Stomatitis
6%
Dysgeusia
6%
Dry skin
6%
Abdominal pain upper
6%
Chest pain
5%
Dyspepsia
5%
Blood alkaline phosphatase increased
5%
Musculoskeletal pain
5%
Erythema
5%
Hypertension
5%
Dysphagia
5%
Nasopharyngitis
5%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Hypotension
4%
Atrial fibrillation
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
2%
Death
2%
Diabetes mellitus
1%
Transient ischaemic attack
1%
Hemiparesis
1%
Pneumothorax
1%
Superior vena cava syndrome
1%
Inappropriate antidiuretic hormone secretion
1%
Neutropenic sepsis
1%
Gastritis
1%
Aortic aneurysm
1%
Sepsis
1%
Pleural infection
1%
Infusion related reaction
1%
Clostridium difficile colitis
1%
Urinary tract infection
1%
Epistaxis
0%
Oropharyngeal pain
0%
Autoimmune nephritis
0%
Appendicitis
0%
Embolism
0%
Bacteraemia
0%
Escherichia sepsis
0%
Type 1 diabetes mellitus
0%
Loss of consciousness
0%
Peripheral motor neuropathy
0%
Tremor
0%
Chronic obstructive pulmonary disease
0%
Aphasia
0%
Gastrointestinal viral infection
0%
Cholecystitis infective
0%
Acute coronary syndrome
0%
Myocarditis
0%
Cardiac arrest
0%
Cardiopulmonary failure
0%
Vitreous haemorrhage
0%
Secondary adrenocortical insufficiency
0%
Hypopituitarism
0%
Food poisoning
0%
Haematemesis
0%
Myocardial infarction
0%
Diverticulum
0%
Serratia sepsis
0%
Cholecystitis
0%
Hepatotoxicity
0%
Infective exacerbation of chronic obstructive airways disease
0%
Lower respiratory tract infection
0%
Diverticulitis
0%
Urosepsis
0%
Fall
0%
Pneumonia haemophilus
0%
Femur fracture
0%
Dehydration
0%
Skin laceration
0%
Spinal fracture
0%
Cerebrovascular accident
0%
Spinal osteoarthritis
0%
Paraneoplastic syndrome
0%
Cognitive disorder
0%
Benign prostatic hyperplasia
0%
Confusional state
0%
Prostatitis
0%
Bronchospasm
0%
Laryngeal haemorrhage
0%
Hypoxia
0%
Haemoptysis
0%
Deep vein thrombosis
0%
Hypertensive crisis
0%
Subacute cutaneous lupus erythematosus
0%
Empyema
0%
Pericardial effusion
0%
Joint injury
0%
Haematuria
0%
Pseudomonas infection
0%
Peripheral embolism
0%
Cancer pain
0%
Proctitis
0%
Limbic encephalitis
0%
Decubitus ulcer
0%
Gouty arthritis
0%
Colitis
0%
Keratitis
0%
Neurogenic bladder
0%
Toxic encephalopathy
0%
Gastroenteritis
0%
Cardiac failure
0%
Tooth infection
0%
Pain
0%
Pneumonia aspiration
0%
Vertigo
0%
Bronchitis
0%
Pleural effusion
0%
Peripheral artery occlusion
0%
Atypical pneumonia
0%
Myositis
0%
Paracancerous pneumonia
0%
Autoimmune uveitis
0%
Respiratory failure
0%
Herpes zoster
0%
Oesophagitis
0%
Vena cava thrombosis
0%
Influenza
0%
Presyncope
0%
Hyperglycaemia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab + Etoposide ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including pembrolizumab) as their most recent therapy and must have had at least a 3-month PFS on this therapy.
Subjects must be enrolled on the trial within 6 weeks of their last infusion of PD-1 or PD-L1 inhibitor therapy.
Subjects whose tumors harbor a mutation in EGFR exon 19 or 21 or have gene rearrangements in ALK or ROS1 must have already been treated with standard targeted therapies. NOTE: Subjects must also have progressed on or after platinum-containing combination chemotherapy.
ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy.
Age ≥ 18 years at the time of consent.
Must be fit enough to receive next-line chemotherapy (either gemcitabine, docetaxel, or pemetrexed [non-squamous only]) according to the discretion of the treating physician.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 4 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of 3 months.

Progression Free Survival (PFS)
3 MONTHS
A measurement from the date of treatment start until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs
Clinical Benefit Rate (CBR)
3 MONTHS
any subject with stable disease for ≥ 3 months, partial response, or complete response assessed via RECISIT 1.1 and irRECIST
Objective Response Rate (ORR)
1 YEAR
The ORR is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence
Overall Survival (OS)
2 YEARS
Overall survival is defined by the date of treatment start to date of death from any cause
Assess Toxicity
2 YEARS
Toxicity will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is carcinoma, non-small-cell lung?

The exact cause of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) remains elusive, however it is believed to be a complex biological disease associated with exposure to environmental and occupational agents, and genetic predisposition. The disease is thought to begin with changes in the normal cells that line the lung tissues. These changes eventually result in the development of cancerous cells. A number of predisposing and risk factors have been identified for lung cancer. Although there is a general acceptance amongst lung physicians of the relationship between smoking and lung cancer, there is still a long way to go before a cure for lung cancer is found. Understanding the role of environmental and occupational factors that may affect the development of lung cancer is an important avenue for further research.

Anonymous Patient Answer

What are the signs of carcinoma, non-small-cell lung?

Signs of carcinoma lung occur on the basis of appearances with the naked eye. They include a mass (tumor), a solitary, irregular opacity (distant metastasis), or an enlarged lymph node. Signs of non-small-cell lung cancer include, most often, coughing up blood (hemoptysis), and shortness of breath (dyspnea) due to enlargement of the lungs or tumor compressing the lung.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Most lung cancers are due to lung smoking and tobacco-related causes. People who have a family history of lung cancer, particularly those with a smoking related gene, are at an increased risk of developing lung cancer. Although most lung cancers have a specific cause, smoking remains an important risk factor in a subset of people; some of these patients will be diagnosed as having 'idiopathic/unknown' lung cancer.

Anonymous Patient Answer

Can carcinoma, non-small-cell lung be cured?

Patients with carcinoma, non-small-cell lung (NSCLC), especially those with adenocarcinoma, have high one-year cure rates, even if they are treated in the postoperative and adjuvant settings. However, the prognosis may deteriorate if they receive chemotherapy postoperatively.

Anonymous Patient Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

About 18 million Americans have at least one major depressive episode each year. Overall, the frequency of major, but not minor, depressive episodes doubled over a 5-year period in men aged 25-44 and women aged 18-44. The frequency doubled in men aged 55-74 and women aged 55-74 and younger in the same 5-year period. The incidence and prevalence of all major depressive episodes in women aged 18-44 increased sharply over 5 years, while there was an increase in incidence in men aged 25-44 and women of similar age, but with no change over 5 years. The prevalence of major depressive episodes increased in men aged 55-74 and women aged 55-74 over 5 years.

Anonymous Patient Answer

What are common treatments for carcinoma, non-small-cell lung?

Cancer patients have many treatment options and most of the treatments should be discussed with their physicians. Survival and progression-free survival show improvements depending on the treatment approach.

Anonymous Patient Answer

What is the survival rate for carcinoma, non-small-cell lung?

Carcinoma is one of the two leading causes of death for lung cancer patients. For non-small-cell lung cancer (NSCLC) surgery is an essential intervention for disease-free and overall survival.

Anonymous Patient Answer

What is pembrolizumab?

The monoclonal antibody pembrolizumab is a new therapeutic agent in the treatment of a variety of cancers. Specifically, pembrolizumab is approved for patients with advanced NSCLC with PD-L1 expression on tumors (tumors with higher expression of PD-L1 have a better treatment outcome).

Anonymous Patient Answer

What are the chances of developing carcinoma, non-small-cell lung?

Based upon our findings the odds of developing the carcinoma, non-small-cell lung were 4.05 to 4.06 times greater than those of developing colon, and 4.18 to 6.33 times greater than those of developing lung. The risk of developing carcinoma, non-small-cell lung was significantly elevated among smokers. [Evaluations Of Clinical Trials(online)](https://www.clinicaltrials.

Anonymous Patient Answer

How quickly does carcinoma, non-small-cell lung spread?

Lung carcinoma can be detected in 9 to 17% of routine clinical settings. Findings from a recent study further supports that the detection of metastatic disease has many limitations and it is better to detect it at the precise stage when applicable. There was a statistically significant difference in the percentage of the patients that are diagnosed with the stage of the primary disease when compared to the group of lung carcinoma patients diagnosed by the stage of the distant organ metastases.

Anonymous Patient Answer

How does pembrolizumab work?

In patients with NSCLC whose disease progresses after first-line platinum-based chemotherapy in the first-line setting, pembrolizumab showed superiority over second-line chemotherapy when compared with chemotherapy alone (hazard ratio [HR]: 0.74) or chemotherapy plus first-line bevacizumab. The benefit was obtained with a modest increase in progression-free survival (HR 0.87). Clinical trials investigating pembrolizumab as a monotherapy in this disease are ongoing.

Anonymous Patient Answer

Is pembrolizumab safe for people?

No new side effects were detected in this study that had not occurred previously. No treatment-related adverse effects were expected because of the lack of immunosuppressive effects.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Non-Small-Cell Lung by sharing your contact details with the study coordinator.