Pembrolizumab for Carcinoma, Non-Small-Cell Lung

2
Effectiveness
3
Safety
Chris OBrien Lifehouse ( Site 0006), Sydney, Australia
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 chemotherapy, immunotherapy, and a targeted therapy can improve survival in people with lung cancer.

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Eligible Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Lung Cancer
  • Nonsquamous 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 5 primary outcomes and 7 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
Part 2: Change from Baseline in Global Health Status/Quality of Life (QoL); Cough; Chest Pain; Dyspnea; and Physical Functioning
Part 2: Time to True Deterioration as Assessed by Change from Baseline in Global Health Status/Quality of Life; Cough; Chest Pain; Dyspnea; and Physical Functioning
Time to True Deterioration in the Composite Endpoint (Combination of Cough, Chest Pain, or Dyspnea)
Day 21
Part 1: Number of Participants with a Dose-limiting Toxicity
Month 27
Part 1: Number of Participants with One or More Adverse Events
Month 19
Part 2: Objective Response Rate (ORR) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Part 2; Duration of Response (DOR) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Month 24
Number of Participants With Study Intervention Discontinuations Due to Adverse Events
Part 2: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Month 27
Part 2: Number of Participants with One or More Adverse Events
Month 36
Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ
Month 47
Part 2: Overall Survival (OS)

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
Placebo group

This trial requires 726 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.

Pemetrexed+Platinum Chemotherapy+Pembrolizumab+LenvatinibParticipants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily for up to 2 years.
Pemetrexed+Platinum Chemotherapy+Pembrolizumab+PlaceboIn Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Carboplatin
FDA approved
Lenvatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 47 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 47 months for reporting.

Closest Location

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0412) - Montreal, Canada

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion (not previously irradiated).
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study intervention but before randomization.
Be abstinence from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
Note: 7 days after lenvatinib/matching placebo is stopped, if the participant is on pembrolizumab only and is greater than 180 days post chemotherapy, no male contraception measures are needed.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC], nonsquamous NSCLC.
Confirmation that Epidermal Growth Factor Receptor (EGFR), ALK Receptor Tyrosine Kinase (ALK), or ROS1 Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated as primary treatment (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements OR presence of a Kirsten Rat Sarcoma (KRAS) gene mutation).
Have measurable disease based on RECIST 1.1. Note: Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.

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 causes carcinoma, non-small-cell lung?

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Exposure to tobacco smoke, asbestos, and radon gases are all risk factors that need to be considered when interpreting trends in lung cancer incidence to detect a changing pattern, particularly within different geographic regions.

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

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Symptoms of cancer include chest pain, dyspnea, and fatigue related to weight loss and weight loss without cachexia. Dyspnea occurs in 25 to 40% of people with lung cancer, while fatigue occurs in 30 to 80%. The symptoms are often less painful than those of COPD. Weight loss occurs in 40 to 70% of people with lung cancer, with the most common cause being cancer cachexia and in some cases metastasis. In addition, one- to three-quarters of people with lung cancer have anemia and fatigue, due to cancer-related anemia and fatigue. Cough, which occurs in 80% of people with lung cancer, is frequently the most common symptom, but may be painful.

Unverified Answer

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

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This article discusses the most common treatments for carcinoma NSCL, and offers a list of treatment options for each type of cancer, in general as well as for advanced stage disease.\n

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What is carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung, is a type of cancer that develops in the lung tissues when cells become abnormally large or change in shape. If left untreated, this disease will cause the cancer cells to spread to other parts of the body, including the brain and the liver. As of December 2016, there are limited treatment options. This article talks with the help of the disease and discusses the signs, symptoms, and treatment of the disease.

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

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Carcinoma, non-small-cell lung is a fatal disease that has a five-year survival of less than 8%. There is currently no known curative therapy for this disease. In the absence of novel therapies, patients with advanced or metastatic disease should not be offered curative treatment.

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

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Based on the current estimates of deaths attributable to [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer)s, cancer of the lung was the most common cause of death in the United States from 1990 through 1995. About 14 percent of the adult lung cancers were attributable to lung cancer in the United States from 1990 through 1995. On a population level, more recent time periods (1990 and 2000) and geographic regions (West North Central, Far West, and West South) were associated with significantly greater rate of lung cancers. Lung of the lung cancer accounted for 40 percent of lung cancer incidence in the United States in 1996. The incidence and mortality of other types of lung cancer are significantly higher in whites than in African Americans or Hispanics.

Unverified Answer

Has pembrolizumab proven to be more effective than a placebo?

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Adding pembrolizumab to paclitaxel was well tolerated and resulted in an improved response rate compared to paclitaxel when used as monotherapy for first- or second-line metastatic NSCLC.

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Is pembrolizumab typically used in combination with any other treatments?

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Pembrolizumab was most frequently combined with other drugs used in cancer care when patients were enrolled in clinical trials, underscoring the importance of evaluating all potential drugs in trials to inform clinical practice.

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How does pembrolizumab work?

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The authors present what is known on the target, mechanism of action, and mechanism of resistance of pembrolizumab. This will allow clinicians to better understand pembrolizumab treatment failures. The authors also discuss the new indications of the FDA approval and the possible strategies used to prolong the efficacy of pembrolizumab, based on the mechanism of a novel target and mechanisms of resistance to therapies.

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Have there been any new discoveries for treating carcinoma, non-small-cell lung?

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The study found that the most frequent adverse events experienced by the lung carcinoma patients were: fatigue, dyspepsia, vomiting, dizziness, dyspnoea. One hundred eleven percent patients experience fatigue and dyspnoea after chemotherapy; 59.3% patients experience dizziness and dyspepsia. Two percent of the patients are not able to do their schedule because of side effects. About two thirds of lung cancer patients develop some sort of hypersensitivity reactions. No serious side effect has been reported yet; hypersensitivity reaction is related to drugs and side effects have no relationship with clinical parameters of lung cancer patients.

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

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Lung carcinoma remains an [incurable disease for many patients, but many patients with advanced lung carcinoma can expect a longer survival time if they are treated with clinical trials for lung cancer.

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

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Carceroma, non-small-cell lung is an aggressive cancer associated with good survival compared to other lung tumors. However, treatment options and survival rates are different depending on the stage. This report provides information on the current treatment options and survival rates to help patients make critical decisions in treatment.

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