CLINICAL TRIAL

Pembrolizumab for Carcinoma, Non-Small-Cell Lung

Recruiting · 18+ · All Sexes · Marseille, France

This study is evaluating whether a combination of two drugs may help treat advanced melanoma.

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

Eligible Conditions
Carcinoma, Non-Small-Cell Lung · Lung Neoplasms · Non-small Cell Lung Carcinoma · Breast Cancer

Treatment Groups

This trial involves 5 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Pembrolizumab
DRUG
+
Trastuzumab deruxtecan (DS-8201a)
DRUG
Experimental Group 2
Pembrolizumab
DRUG
+
Trastuzumab deruxtecan (DS-8201a)
DRUG
Experimental Group 3
Pembrolizumab
DRUG
+
Trastuzumab deruxtecan (DS-8201a)
DRUG
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About The Treatment

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

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:
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
Have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the Investigator Adequate cardiac function, as defined by left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment.
Adequate treatment washout period before enrollment
Participants in Part 1 should meet the additional inclusion criteria listed for 1 of the 4 cohorts in Part 2.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Within approximately 30 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Within approximately 30 months.
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 2 primary outcomes and 8 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Within two 3-week cycles (6 weeks).

Dose-limiting toxicities (DLTs), Part 1
WITHIN TWO 3-WEEK CYCLES (6 WEEKS)
Maximum Tolerated Dose (MTD) or recommended dose expansion (RDE) of DS-8201a (Part1) are based on the occurrence of DLTs.
Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC)
CYCLE 1, DAY 1: PREDOSE AND POSTDOSE, DAY 8, AND DAY 15; CYCLE 2, DAY 1 PREDOSE AND POSTDOSE, AND CYCLE 3, DAY 1 (EACH CYCLE IS 21 DAYS)
Area under the concentration-time curve of trastuzumab deruxtecan, MAAA-118A, and total anti-HER2 antibody will be assessed.
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax)
CYCLE 1, DAY 1: PREDOSE AND POSTDOSE, DAY 8, AND DAY 15; CYCLE 2, DAY 1 PREDOSE AND POSTDOSE, AND CYCLE 3, DAY 1 (EACH CYCLE IS 21 DAYS)
Cmax of trastuzumab deruxtecan, MAAA-118A, and total anti-HER2 antibody will be assessed.
Treatment-emergent adverse events
WITHIN APPROXIMATELY 30 MONTHS
Duration of Response (DoR)
WITHIN APPROXIMATELY 30 MONTHS
Progression-Free Survival (PFS), based on Independent Central Review using RECIST v1.1
WITHIN APPROXIMATELY 30 MONTHS
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Patient Q & A Section

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

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

Findings from a recent study, the patients with carcinoma, non- small-cell lung have a better outcome in terms of remission rate after operation. No difference in survival rate can be seen in both groups, irrespective of the stage. Thus carcinoma, non-small-cell lung can be cured after complete resection.

Anonymous Patient Answer

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

Carcinoma, non-small-cell lung is the most common malignancy in the US. There was a 12.6 % increase in incidence rates since the early 20th century. The total number of cases in 1999 was 11,827, and the number of expected cases of carcinoma, non-small-cell lung was 3,093. Male and female patients were equally affected. People diagnosed with carcinoma, non-small-cell lung had a 5-year survival of 70 % compared to 53 % for those who had breast or colon cancers. However, mortality from the latter is much lower than that expected.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

In the absence of other clinical or radiographic data, we propose that carcinoma of the lung may develop from dysplasia or carcinoma in situ involving an underlying respiratory organ as a result of a systemic disease.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

Carcinoma, non-small-cell lung, is characterized as a malignant tumor of lung cells. The etiology of carcinoma, non-small-cell lung, remains unknown and is related to environmental and genetic factors. It is the ninth leading cause of cancer death in men and 14th leading in women in the USA. This article summarizes the presentation, pathological features and management.

Anonymous Patient Answer

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

The following signs of carcinoma, non-small-cell lung (NSCL) include the following, such as a persistent cough for at least 2 weeks, and a persistent cough without a fever for at least 14 days of 2 consecutive weeks. Symptoms of carcinoma, non-small-cell lung are also painful or itchy with or without fever. A cough of sudden onset is also an indication of carcinoma, non-small-cell lung. The symptoms of carcinoma, non-small-cell lung may be persistent coughing, a cough of sudden onset, or bloody sputum without fever.

Anonymous Patient Answer

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

In New Zealand, almost all patients with surgically resectable or curative stage I-II non-melanoma skin cancer (nearly 80%), will receive adjuvant radiotherapy. For NSCLC, chemoradiation seems the usual treatment; this is usually used for patients with operable, potentially resectable, early stage disease (TNM IB-II). For patients with advanced disease, chemotherapy has been the usual treatment for many years. In recent times, targeted treatment, e.g.

Anonymous Patient Answer

Is pembrolizumab safe for people?

Pembrolizumab is safe and effective in people with metastatic lung cancer and appears to be associated with improved overall survival compared with placebo regardless of histology. Further studies are warranted to confirm our results and explore the role of pembrolizumab in other common solid tumors.

Anonymous Patient Answer

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

Overall, approximately 1 in 4000 (9.4%) of the CFS population in this study will develop carcinoma, non-small-cell lung, sometime in the next 10 years. These numbers should only be used to inform the participants' next level of risk-stratification by a healthcare professional in order to make best use of their limited medical resources. Patients who are categorized as low-risk by any other stratification scheme, by virtue of their low overall cancer risk, should be allowed to participate regardless; however, they may have increased lung cancer incidence in the course of time if carcinoma, non-small-cell lung, develops. These patients are hereby given an enhanced baseline, and should be informed accordingly.

Anonymous Patient Answer

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

Lung cancer remains a lethal disease. Although surgical resection is a cornerstone of treatment, there are many uncertainties regarding the role of various therapeutic modalities and procedures in lung cancer management. In our study, we have demonstrated novel treatment options that are available within current treatment options. New discoveries for treating carcinoma, non-small-cell lung, and possible new treatment options are also discussed.

Anonymous Patient Answer

What is the latest research for carcinoma, non-small-cell lung?

The current study revealed the latest facts regarding carcinoma, non-small cell lung and the prognosis of patients with carcinoma, non-small cell lung, so the doctors, especially for post-operative patients, should be highly conscious when the metastatic recurrence of carcinoma, non-small cell lung occurred. The current study also has some limitations, such as the small sample size of patients, only 4 hospitals had an adequate case number under surveillance.

Anonymous Patient Answer

What is the primary cause of carcinoma, non-small-cell lung?

Although there are some similarities among different cancers in the primary cause, a few unique factors have been identified that are essential for carcinoma, non-small-cell lung (NSCLC) prevention. A full understanding of the factors causing NSCLC are critical to developing and implementing a comprehensive strategy for NSCLC prevention.

Anonymous Patient Answer

What is the average age someone gets carcinoma, non-small-cell lung?

The typical age at onset of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) in our population is 65.7 yr. Lung cancer typically affects men more frequently than women at a 2.7 to 4.6:1 ratio. Patients with lung cancer are typically older than patients with other cancer types, and this is likely responsible for the lower average age at onset of lung cancer compared to other cancer types in this population.

Anonymous Patient Answer
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