Pembrolizumab for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
2
Effectiveness
3
Safety
Jiangsu Cancer Hospital ( Site 0101), Nanjing, China
Carcinoma, Non-Small-Cell Lung+2 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a combination of two drugs can improve the survival of people with lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Non-small Cell Lung Cancer
  • Lung Neoplasms

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 23 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Through 90 days post last dose of study treatment (Up to approximately 27 months).

Month 25
Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Change from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
Change from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
Change from Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Change from Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score
Change from Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
Change from Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
Time to True Deterioration (TTD) Based on Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Time to True Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
Time to True Deterioration (TTD) Based on Change from Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
Time to True Deterioration (TTD) Based on Change from Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
Month 27
Number of Participants Who Experience an Adverse Event (AE)
Month 24
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Month 25
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Overall Survival (OS)
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Pembrolizumab + Placebo
Pembrolizumab + Lenvatinib
Placebo group

This trial requires 623 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Pembrolizumab + LenvatinibParticipants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Pembrolizumab + PlaceboParticipants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 25 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 25 months for reporting.

Closest Location

Parkview Cancer Center ( Site 0542) - Fort Wayne, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Non-Small-Cell Lung or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer. show original
You have a systolic BP of ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization. show original
Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition]).
Has measurable disease based on RECIST 1.1.
Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory.
Has a life expectancy of ≥3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization.
Male participants must agree to the following during the treatment period and for ≥7 days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
Female participants are eligible to participate if not pregnant or breastfeeding, and ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR 2) Is a WOCBP and is using a highly effective contraceptive method that has a low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days post lenvatinib/matching placebo, whichever occurs last.
Has adequate organ function.

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

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When you go to the doctor's office to get an X-ray, you could also see a CT scan because they're very similar. The main difference between the CT and the X-ray is the CT has better anatomical resolution and CT should get done first. The CT is the only scan that can show the lungs better than the X-ray. When you see a CT scan it will show the extent and size of all your lungs, as well as any calcifications in your lungs which will be good stuff to know to find any suspicious nodules.

Unverified Answer

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

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The long-term survival of carcinoma, non-small-cell lung after surgical resection is extremely low (30%). For carcinoma, non-small-cell lung with one or more malignant lesions metastatic at the time of the initial surgery, the long-term survival after resection is significantly improved to 80%.

Unverified Answer

What is carcinoma, non-small-cell lung?

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Carcinoma, NSCLC is defined as a group of malignant tumors that may be carcinoma, SCC, or AC (histopathology type I) of the lung. In clinical trials (whether clinical or in vitro studies) the histopathology type I is usually used in experiments because of the possibility of misinterpretation of results. In recent years, there have been many advances in the pathological diagnosis of carcinoma, NSCLC. In the clinical trials, NSCLC subtypes and the histopathology type are usually recorded in report as a reference for the patients (the patients are not blinded).

Unverified Answer

What causes carcinoma, non-small-cell lung?

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Although the epidemiology of this disease is complicated, several risk factors have been associated with an increased likelihood of developing it. In addition, carcinoma of the lung remains a medical mystery, with the precise cause of the majority of cases not known.

Unverified Answer

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

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The most commonly used treatments for lung cancer are surgery, radiation therapy, and chemotherapy, with surgery most commonly used and surgery most often used for non-small-cell lung cancer. In the United States, most people survive <2 years after diagnosis. Survival after initial diagnosis varies greatly for different subgroups based on gender, race, and age. Women and Blacks have a better survival than men and Whites.

Unverified Answer

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

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In 2013, 431,534 people in the United States had the diagnosis of carcinoma, non-small-cell lung. Of the total number of cases, there were 246,483 cases of adenocarcinoma, 251,542 cases of squamous cell carcinoma, and 34,926 cases of small cell carcinoma. About 28,000 more cases of carcinoma, non-small cell lung were diagnosed in males than in females. People diagnosed with this type of cancer were more commonly than not middle aged.

Unverified Answer

Is pembrolizumab typically used in combination with any other treatments?

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Pembrolizumab is occasionally used in combination with several agents, particularly chemotherapy. However, the overall number of patients who would be eligible for pembrolizumab was small. Further prospective trials in larger numbers are needed to confirm and optimize the use of pembrolizumab among patients with solid tumors.

Unverified Answer

Does carcinoma, non-small-cell lung run in families?

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Findings from a recent study shows a strong association between lung cancer and a hereditary basis. A multilocus genetic model is proposed and family linkage in an appropriate case-control design and high-resolution scanning is needed to demonstrate an association.

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Who should consider clinical trials for carcinoma, non-small-cell lung?

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Surgical therapy is the standard of care for NSCLC. Patients with Stage III malignancy, or Stage III tumors of limited size (<30mmx3 mm), should be considered for active surveillance or clinical trials. Patient age, number of comorbidities, and disease stage can guide patient selection into one of the aforementioned trials.

Unverified Answer

How does pembrolizumab work?

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A significant ( P < 0.0001) proportion of patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab experienced an objective response and survival benefit compared with patients who received chemotherapy alone with or without pembrolizumab. Furthermore, a minority of patients (14 %) experienced treatment-related side effects. In all, patients receiving pembrolizumab had a lower rate ( P < 0.0001) and severity of drug-related skin toxicity and treatment-related fatigue compared with chemotherapy without pembrolizumab. A higher rate ( P = 0.0402) of serious liver toxicity was observed at 3.4 per 10,000 vs.

Unverified Answer

What are the latest developments in pembrolizumab for therapeutic use?

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Pembrolizumab is a novel therapeutical tool in advanced NSCLC. The study confirms the high response rate in treatment-refractory disease. Furthermore, there seems to be an increased incidence of peripheral nervous system events (PNIS); the frequency of this new signal is around 4%, which seems to be higher than the previously described (1%), and may be related to a larger duration of pembrolizumab therapy.

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

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Survival rates for most subtypes of carcinoma, non-small-cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s do not appear to be improving since their initial publication in 1971. Because of the rarity of specific histology as a risk factor for mortality, the data do not preclude the possibility of a substantial improvement in survival for certain histology groups, such as adenocarcinoma. Cancer 2006;122:974-80.

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