CLINICAL TRIAL

KRT-232 for Small-cell Lung Cancer

Recruiting · 18+ · All Sexes · Alicante, Spain

KRT-232 in Subjects With Relapsed or Refractory Small Cell Lung Cancer

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About the trial for Small-cell Lung Cancer

Eligible Conditions
Small-cell Lung Cancer · Recurrent Small Cell Lung Cancer (SCLC) · Lung Neoplasms · Extensive-stage Small Cell Lung Cancer (SCLC) · Small Cell Lung Carcinoma

Treatment Groups

This trial involves 2 different treatments. KRT-232 is the primary treatment being studied. Participants will be divided into 2 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
KRT-232
DRUG
Experimental Group 2
KRT-232
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Small-cell Lung Cancer or one of the other 4 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed diagnosis of SCLC documented as TP53WT
Disease must be measurable per RECIST Version 1.1
Evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. Subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse.
Subjects must have received a checkpoint inhibitor (PD-1 or PD-L1) unless contraindicated if checkpoint inhibitors are approved and available.
ECOG ≤ 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: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
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 KRT-232 will improve 1 primary outcome and 4 secondary outcomes in patients with Small-cell Lung Cancer. Measurement will happen over the course of 24 weeks.

Objective response rate (ORR) of each arm
24 WEEKS
The proportion of subjects achieving partial response or better per RECIST 1.1
Disease control rate (DCR) of each arm
24 WEEKS
The proportion of subjects achieving stable disease or better per RECIST 1.1
Duration of response (DOR) of each arm
1 YEAR
Time from initiation of response to disease progression or death
Overall survival (OS) of each arm
1 YEAR
Time from first dose to death
Progression-free survival (PFS) of each arm
1 YEAR
Time from first dose to disease progression or death

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 extensive-stage small cell lung cancer (sclc) be cured?

In patients with new diagnosis/recurrent sclc, only a small fraction of them can be made "free of disease" regardless of their treatment regimen, with a chance of long term survival and disease control.

Anonymous Patient Answer

What are common treatments for extensive-stage small cell lung cancer (sclc)?

In a recent study, findings indicate that the use of chemotherapy and radiotherapy alone in sclc is not effective. Chemoradiotherapy offers the best treatment when feasible in patients with extensive-stage sclc.

Anonymous Patient Answer

How many people get extensive-stage small cell lung cancer (sclc) a year in the United States?

There are an estimated 34 deaths from SCLC a year for men aged 25-64 years. We cannot measure extrapolated absolute numbers of cancer deaths in this age group from population-based studies like the Behavioral Epidemiologic Catchment Area Survey because age groups are not reported on death certificates. However, one study of the National Health Interview Survey (1982-1987) estimated that SCLC accounted for 0.5% (0.5 per 1,000) of all deaths. A large study of death certificates in the United States from 1977-1989 identified 748 cases of SCLC per year. Based on the above estimates, one would expect 590 SCLC cases a year among men age 25-64 years.

Anonymous Patient Answer

What are the signs of extensive-stage small cell lung cancer (sclc)?

A careful history with emphasis on smoking cessation and history of previous lung cancer is important for the evaluation of patients with squamous cell carcinoma of the lungs. Examination, radiologic imaging, and lung biopsy should be obtained as part of initial evaluation or followup. There should also be careful consideration of histopathology for staging and classification. The most common initial radiologic feature of extensive-stage SCLC is a mass or mass-like area of consolidation on chest CT or radiographs, often corresponding to a homogenous solid mass or multifocal solid masses. This finding is associated with a very poor prognosis, even with multimodal therapy.

Anonymous Patient Answer

What causes extensive-stage small cell lung cancer (sclc)?

A history of tobacco smoking is the leading cause of SCLC. A history of smoking may result in SCLC by at least two mechanisms: carcinogens or by chronic inflammation that has been shown to promote neoplastic transformation. These mechanisms need not be mutually exclusive and the current study does not exclude a potentially complementary role for other exposures.

Anonymous Patient Answer

What is extensive-stage small cell lung cancer (sclc)?

SCLC is an aggressive and rare form of lung cancer. Typically, it originates in the upper right or lower lobe. It has a poor prognosis and has a 5-year survival rate of 17-18%; this rate is in contrast with other types of lung cancer, which have a 5-year survival rate of 50-70%. SCLC is the second most common form of lung cancer in the US, after lung adenocarcinoma.

Anonymous Patient Answer

What are the latest developments in krt-232 for therapeutic use?

Because of the high rate of survival and the low frequency of metastasis, the use of this agent for advanced and recurrent pancreatic cancer is still being tested in a larger group of patients.

Anonymous Patient Answer

What are the chances of developing extensive-stage small cell lung cancer (sclc)?

Small cell lung carcinoma (sclc) has the worst prognosis among all types of NSCLC, especially in young males and those who are nondiabetic. However, patients who developed extensive-stage sclc had a mean age of 47 years and a slight male predominance (60%) as compared with those who did not develop extensive-stage sclc (32% and 49%, respectively, P = 0.006). Results from a recent paper suggest that patients who developed extensive-stage sclc tended to be a different population from those who did not develop extensive-stage sclc.

Anonymous Patient Answer

Is krt-232 typically used in combination with any other treatments?

The limited data to date suggest that krt-232 displays antitumor activity at a low dosage and will be appropriate for clinical development. As krt-232 may induce peripheral side effects such as insomnia and diarrhea, future clinical studies will need to be vigilant in evaluating the incidence and severity of these side effects and their impact on quality of life.

Anonymous Patient Answer

How serious can extensive-stage small cell lung cancer (sclc) be?

With a median survival of 6.3 months, sclc can cause serious and permanent disease in a substantial proportion of young adults presenting with metastatic disease.

Anonymous Patient Answer

What are the common side effects of krt-232?

In our present preclinical study, no significant adverse side effects are observed in the mice. Results from a recent clinical trial suggest that krt-232 may be a good candidate for clinical trials.

Anonymous Patient Answer

How does krt-232 work?

Results from a recent paper has demonstrated that systemic krt-232 treatment reduced tumor growth. Additionally, tumor necrosis, edema, and vascular permeation are all reduced following systemic krt-232 treatment. Further, krt-232-mediated apoptosis is thought to be both caspase dependent and mitochondria-dependent. Overall, the study demonstrated that systemic krt-232 treatment significantly reduced tumor volume.

Anonymous Patient Answer
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