ALRN-6924 for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gabrail Cancer Institute, Canton, OH
Non-Small Cell Lung Carcinoma (NSCLC)+3 More
ALRN-6924 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can prevent chemotherapy-induced side effects in people with lung cancer.

See full description

Eligible Conditions

  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Small-cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Study Objectives

This trial is evaluating whether ALRN-6924 will improve 2 primary outcomes in patients with Non-Small Cell Lung Carcinoma (NSCLC). Measurement will happen over the course of Approximately 6 months.

Approximately 19 months
Phase 1b Part 1 SCLC
Approximately 6 months
Phase 1b Part 2 NSCLC

Trial Safety

Safety Progress

1 of 3

Other trials for Non-Small Cell Lung Carcinoma (NSCLC)

Trial Design

3 Treatment Groups

Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed
1 of 3
Part 1 SCLC: ALRN-6924+Topotecan
1 of 3
Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed
1 of 3
Experimental Treatment

This trial requires 35 total participants across 3 different treatment groups

This trial involves 3 different treatments. ALRN-6924 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part 2 NSCLC: Placebo+Carboplatin+Pemetrexed
Part 1 SCLC: ALRN-6924+Topotecan
Part 2 NSCLC: ALRN-6924+Carboplatin+Pemetrexed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Placebo
1995
Completed Phase 3
~2810
Topotecan
FDA approved
Carboplatin
FDA approved
ALRN-6924
2016
Completed Phase 2
~210

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 19 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 19 months for reporting.

Closest Location

Gabrail Cancer Institute - Canton, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histopathological confirmation of Stage IV NSCLC of adenocarcinoma histology. Cytological diagnosis of NSCLC is acceptable if sufficient tumor tissue is available for p53 mutation analysis. FDA approved liquid biopsies are also acceptable.
Presence of one or more p53 mutations.
Measurable disease using RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Adequate hematological status.
Adequate hepatic and renal function.
Phase 1b, Part 2 NSCLC

Patient Q&A Section

Can small cell lung carcinoma be cured?

"The cure rate of SCLC varies according to tumor stage and treatment history. Although most SCLC cells are susceptible to treatment, more than two-thirds of previously treated patients present with recurrent disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for small cell lung carcinoma?

"Small cell lung carcinoma presents with symptoms that have traditionally been associated with systemic disease. Consequently, the majority of patients require symptomatic treatment as well as systemic treatment. Treatment options must be carefully tailored in order to maximize survival and symptom control for each patient." - Anonymous Online Contributor

Unverified Answer

What causes small cell lung carcinoma?

"SCLC may be a result of other diseases. The development of SCC is not clear, although viral infections such as HPV, KSHV, EBV, or a fungal infection are potential causes of SCC. The use of tobacco products could be a risk factor for SCC." - Anonymous Online Contributor

Unverified Answer

What are the signs of small cell lung carcinoma?

"Nodules detected on an HRCT are more commonly associated with SCLC. In particular, the presence of a mass effect of the nodule is highly suggestive of SCLC. Although a number of other imaging features are not as specific as a mass effect, they do contribute to the assessment of a case as potentially suggestive of a SCLC." - Anonymous Online Contributor

Unverified Answer

What is small cell lung carcinoma?

"Lung cancers have a high rate of metastatic metastatic disease. Lung cancer staging includes the TNM system which classifies the T and N stage of a tumor as local invasion and metastatic spread respectively. Stage IV disease is defined by a combination of metastatic spread and locally advanced disease. Stage IV disease is an indicator of an aggressive and highly lethal lung cancer disease." - Anonymous Online Contributor

Unverified Answer

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

"About 30,000 people in the United States will die of lung cancer each year. The prevalence of lung cancer is highest in black individuals and women with tobacco consumption. Lung cancer is second in men after colon cancer. A higher percentage of whites is likely to be diagnosed with lung cancer. A significantly higher mortality rate exists in black adults 25 years and older with lung cancer compared to whites." - Anonymous Online Contributor

Unverified Answer

How serious can small cell lung carcinoma be?

"Patients who had a good performance status and small burden of symptoms reported a high burden of disease and were very likely to have a fatal outcome. The clinical and pathological features of the illness are the most important predictors of prognosis." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of alrn-6924?

"Although [Alemtuzumab|alrn-6924|has|been approved in the USA for the treatment of SCLC] is being evaluated in clinical trials, alrn-6924 could be an even better choice for treatment of alveolar squamous cell carcinoma"

"Cypraeovula\n\nCypraeovula is a genus of sea snails, marine gastropod mollusks in the family Cypraeidae, the cowries." - Anonymous Online Contributor

Unverified Answer

Does alrn-6924 improve quality of life for those with small cell lung carcinoma?

"ALR-6924 is a promising lead compound for development of a treatment for SCLC. It has promising early pharmacology in preclinical studies and is well tolerated in subjects." - Anonymous Online Contributor

Unverified Answer

What does alrn-6924 usually treat?

"The side effects related to pemetrexed were minimal. Thus, it is considered to be safe in alrn-6924 therapy. This drug can be helpful in preventing tumor relapse. In addition, alrn-6924 does not cause severe hematotoxicity or hepatotoxicity; therefore, alrn-6924 is considered to be one of the most useful agents in adjuvant chemotherapy. We, therefore, consider alrn-6924 to be one of the most effective compounds for use in breast cancer adjuvant chemotherapy." - Anonymous Online Contributor

Unverified Answer

How does alrn-6924 work?

"Alrn-6924 appears to affect multiple biological pathways in malignant cells, including tumor growth, angiogenic activity, survival, and migration. Further study of alrn-6924 and its other biological targets in malignant cells may lead to novel compounds that enhance or inhibit tumor responses to radiation therapy." - Anonymous Online Contributor

Unverified Answer

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

"Overall, this analysis demonstrated that most therapies tested were effective in treating SCLC, but the treatment duration must be increased in some groups because of the short time interval between diagnosis and therapeutic approach." - Anonymous Online Contributor

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