CLINICAL TRIAL

MK-4830 for Small Cell Lung Carcinoma

Recruiting · 18+ · All Sexes · Budapest, Hungary

This study is evaluating whether investigational agents can be used in combination with pembrolizumab and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCL

See full description

About the trial for Small Cell Lung Carcinoma

Eligible Conditions
Lung Neoplasms · Small Cell Lung Cancer (SCLC) · Small Cell Lung Carcinoma

Treatment Groups

This trial involves 3 different treatments. MK-4830 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
MK-4830
BIOLOGICAL
+
Cisplatin
DRUG
+
Pembrolizumab
BIOLOGICAL
+
Etoposide
DRUG
+
Carboplatin
DRUG
Experimental Group 2
Cisplatin
DRUG
+
Pembrolizumab
BIOLOGICAL
+
MK-5890
BIOLOGICAL
+
Etoposide
DRUG
+
Carboplatin
DRUG
Experimental Group 3
Cisplatin
DRUG
+
Lenvatinib
DRUG
+
Pembrolizumab
BIOLOGICAL
+
Etoposide
DRUG
+
Carboplatin
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Lenvatinib
FDA approved
Pembrolizumab
FDA approved
Etoposide
FDA approved
Carboplatin
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:
You are female and not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman/women of childbearing potential (WOCBP) or is a WOCBP and uses a contraceptive method that is highly effective with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. show original
Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (7 days); Etoposide, Cisplatin, or Carboplatin (180 days) and Pembrolizumab, MK-4830, or MK-5890 (no contraception measures); refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention
You are breastfeeding at the time of study intervention. show original
You have measurable disease per RECIST 1. show original
Submits an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated where such sample exist. show original
You have an ECOG performance status of 0 or 1 assessed within 7 days before randomization. show original
You have adequate organ function within 10 days before the first dose of study intervention. show original
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: Baseline, 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 5 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 MK-4830 will improve 2 primary outcomes and 7 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Baseline, Week 19.

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale (Items 29 and 30) at Week 19
BASELINE, WEEK 19
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. The mean change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Six-Month Progression-Free Survival (PFS) as Assessed by BICR per RECIST 1.1
UP TO APPROXIMATELY 6 MONTHS
Six-month PFS is defined as the survival without documented disease progression (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Number of Participants Who Discontinued Study Treatment Due to an AE
UP TO APPROXIMATELY 5 YEARS
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
Duration of Response (DOR) as Assessed by BICR per RECIST 1.1
UP TO APPROXIMATELY 5 YEARS
DOR is defined as the time from first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) until first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Number of Participants Who Experienced an Adverse Event (AE)
UP TO APPROXIMATELY 5 YEARS
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be presented.
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
UP TO APPROXIMATELY 5 YEARS
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
See More

Patient Q & A Section

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

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

The true incidence of SCLC in the United States is unknown, but estimates range from 25 to 150 cases per 100,000 population. A study in 1983 found that 30% of the SCLC cases examined were diagnosed at stage I and II, while 10% were diagnosed at stage III. In general, in the United States the pathologic staging of SCLC is well correlated with prognosis. The significance of stage IB and II disease remains unclear. Although this study was performed over 20 years ago, demographic trends over the last decade suggest an increasing frequency and a later age of diagnosis of SCLC.

Anonymous Patient Answer

What is the survival rate for small cell lung carcinoma?

Although there has been some improvement in survival rates, the 5-year survival rate remains poor. This is likely due to low number of cases treated in hospitals, which could affect treatment outcome. Since SCLC is rare in most countries, lack of adequate diagnostic resources could be one of the reasons for this poor prognosis. Survival rates are higher when the disease is diagnosed early and staged appropriately. Treatment options include surgery, chemotherapy, radiation therapy, targeted therapy, immunotherapy, and palliative care. Palliative care should be offered to patients who are unable to undergo curative therapies.

Anonymous Patient Answer

Does small cell lung carcinoma run in families?

Data from a recent study of this study do not support a familial susceptibility to SCLC. Considering the low prevalence of SCLC in the general population, we recommend caution in applying these findings to the general population.

Anonymous Patient Answer

What are the chances of developing small cell lung carcinoma?

The New York Cancer Registry indicated a significant increase in SCLC incidence over a time frame of 3 decades, particularly among non-Hispanic white males aged 50–69 years old. Findings from a recent study has shown a significant association between smoking and SCLC. Findings from a recent study support the need for further investigations to identify risk factors involved in the development of SCLC.

Anonymous Patient Answer

What is the latest research for small cell lung carcinoma?

There are many immunotherapies for SCLC; they could provide an additional option for patients who have no good response to chemotherapy. The choice of therapeutic schedule depends upon which drug is used as well as the stage of disease.

Anonymous Patient Answer

Have there been other clinical trials involving mk-4830?

MK-4830 has not undergone any phase III clinical trial in SCLC. However, several other agents have undergone clinical trials in SCLC, including MK-4870, MK-4658, MK-7508, and MK-1791. These studies showed that MK-4870 was well tolerated and was moderately active in patients with SCLC. However, more data are needed regarding the efficacy of MK-4870 compared to MK-4830 in patients with SCLC. MK-7508 showed promising results in a phase II trial, manifested as an increased progression-free survival rate.

Anonymous Patient Answer

What are common treatments for small cell lung carcinoma?

There are several effective chemotherapy regimens for SCLC but they have limited benefit compared with supportive care alone. Radiotherapy is often used in combination with surgery and chemotherapy for people with locally advanced disease (stages III and IV), but its benefit is less clear. One review found no evidence to support chemotherapy plus radiotherapy for people whose disease has spread beyond the lungs. People with early-stage disease may benefit from adjuvant therapy; however, more research is needed before this approach can be recommended routinely. New approaches such as immunotherapy are being studied for use in conjunction with standard treatments. These treatments may improve outcomes for people with SCLC if they work by slowing growth of tumor cells or reducing their ability to invade healthy tissues.

Anonymous Patient Answer

Is mk-4830 typically used in combination with any other treatments?

MK-4830 was not commonly used in combination with other therapies In a recent study. Further research should be conducted to determine more accurately the frequency and effectiveness of MK-4830 use in combination therapies.

Anonymous Patient Answer

What is mk-4830?

Thus far, this compound has been tested in three different models of human cancers (see below). It appears to be an effective anti-cancer agent in both solid tumors and hematologic malignancies. Because of its unique mechanism of action, it may have applications beyond cancer treatment.

Anonymous Patient Answer

Can small cell lung carcinoma be cured?

To cure SCLC is an unachievable goal because of its aggressive nature and poor prognosis. Currently there are no effective therapies available for SCLC and many patients die within 3 years of diagnosis. Given the poor survival rate of SCLC patients, future research should focus on improving outcomes through innovative multimodal approaches.

Anonymous Patient Answer

What is the primary cause of small cell lung carcinoma?

Small cell lung carcinoma (SCLC) has been associated primarily with tobacco smoking. It is possible that SCLC development could be increased if there was a higher prevalence of smokers among the Patna population, particularly during childhood.

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