Selpercatinib for Carcinoma, Non-Small-Cell Lung

Phase-Based Estimates
2
Effectiveness
3
Safety
COT - Centro Oncológico do Triângulo S.A., Uberlândia, Brazil
Carcinoma, Non-Small-Cell Lung
Selpercatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Non-Small-Cell Lung

Study Summary

This study is evaluating whether a drug may help prevent cancer from returning in individuals with early stage non-small cell lung cancer.

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Treatment Effectiveness

Effectiveness Estimate

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

Compared to trials

Study Objectives

This trial is evaluating whether Selpercatinib will improve 1 primary outcome and 7 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Baseline.

Baseline
Positive Predictive Value (PPV) of Local Lab Tests Compared to Central Lab Test to Detect Rearranged during Transfection (RET) Gene Fusion
Year 3
Mean Change from Baseline over Time in NSCLC Symptoms
Mean Change from Baseline over Time in Physical Function
Year 9
Overall Survival (OS)
Year 9
Progression Free Survival on the Next Line of Treatment (PFS2)
Year 7
Event-Free Survival (EFS)
Time to Distant Disease Recurrence in the Central Nervous System (CNS)
Year 7
EFS

Trial Safety

Safety Estimate

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

Compared to trials

Trial Design

2 Treatment Groups

Placebo
Selpercatinib
Placebo group

This trial requires 170 total participants across 2 different treatment groups

This trial involves 2 different treatments. Selpercatinib 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.

Selpercatinib
Drug
Selpercatinib administered orally.
Placebo
Drug
Placebo administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selpercatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization to death from any cause (estimated as up to 9 years)]
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly randomization to death from any cause (estimated as up to 9 years)] for reporting.

Closest Location

Mayo Clinic in Florida - Jacksonville, FL

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:
The patient has a very good or good performance status, as assessed by the Eastern Cooperative Oncology Group (ECOG). show original
The baby would most likely survive without chemotherapy for 10 weeks. show original
The person must have a confirmed stage of IB, II, or IIIA NSCLC histologically. show original
The tumor must have an activating RET gene fusion in order to be eligible for this trial show original
patients who have received definitive locoregional therapy with curative intent (surgery or radiotherapy) for Stage IB, II, or IIIA NSCLC are not eligible for enrollment in the study. show original
Must have received the available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, based on the investigator's discretion. show original
Must have completely recovered from definitive therapy (surgery or radiotherapy) as well as adjuvant therapy before the start of the study. show original
If adjuvant chemotherapy was administered, the baby would be born around 26 weeks. show original
The patient has adequate hematologic, hepatic, and renal function. show original
People who could potentially have children will have to use birth control for the entire study and for at least two weeks after the study is over. show original

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?

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Patients may have long-term disease-free survival after surgery. However, patients must be identified early in their disease course prior to relapse. Adjuvant chemotherapy improves survival and decreases the risk of death significantly.

Unverified Answer

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

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There are a wide range of treatment options for lung carcinoma that are based on the extent and stage of disease at presentation and the patient's treatment preferences. In the case of metastatic/advanced disease the most common first-line treatment is chemotherapy. Although the majority of patients with lung carcinoma receive treatment, most die of their disease, so there remains a need to identify the optimal treatments for lung carcinoma. There is an urgent need to optimise strategies to maximize treatment options, quality of life and patient outcome in metastatic/advanced lung cancer.

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

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Around 36,000 people in the United States will be diagnosed with NSCLC. This equates to about 3.8 new diagnoses per 100,000 population per year. In our NSCLC registry, over one quarter of the patients have never smoked, and over a third had a good compliance with smoking guidelines, showing that in many cases, lung cancer control can be achieved by giving up smoking.

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

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Many signs and symptoms of lung cancer may include fever, unintentional weight loss, coughing, or hemoptysis. Severe upper-respiratory tract symptoms including hoarseness, pain, difficulty breathing, shortness of breath and unexplained weight gain are the most important of the symptoms that indicate lung cancer. Early detection of lung cancer is possible by implementing these signs and symptoms. The symptoms and signs of lung cancer may mimic those of other related conditions including emphysema and bronchitis. The signs and symptoms of emphysema include cough, chest pain, shortness of breath, weakness, and swelling and discomfort in the neck, jaw, or shoulders.

Unverified Answer

What causes carcinoma, non-small-cell lung?

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Carcinoma, non-small-cell lung is a heterogeneous group of neoplastic diseases that includes atypical adenomatous hyperplasia, bronchioloalveolar carcinoma and small cell lung cancer. The epidemiology of these disease entities is not well understood.

Unverified Answer

What is carcinoma, non-small-cell lung?

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About 6% of the population had the carcinoma NSCLC. About 70% were diagnosed with this cancer in the USA and the rest developed it in other areas of the world. The majority of them were diagnosed after they developed symptoms. The most common site for the carcinoma NSCLC was the large and middle branches of the main bronchi and it developed earlier than the small airways. The carcinoma NSCLC of the large and middle branch of the main bronchi was diagnosed after the development of symptoms in 65.5% of the patients. In order to identify this specific type of cancer and to make a treatment plan, a complete clinical evaluation was mandatory.

Unverified Answer

Have there been other clinical trials involving selpercatinib?

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This is the first clinical study of selpercatinib. Since selpercatinib is an oral synthetic small molecule that targets both epidermal growth factor receptor (EGFR) and MET, future trials are planned to assess selpercatinib in combination with other EGFR and MET targeting agents.

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How does selpercatinib work?

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Selpercatinib inhibits PDGFRβ/α in vitro and in vivo and has a broad clinical profile. As selpercatinib is a potent and selective inhibitor of PDGFRα and PDGFRβ, it is an attractive candidate for targeted therapy of cancer patients with high PDGFR expression.

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What are the latest developments in selpercatinib for therapeutic use?

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Selpercatinib demonstrated significant PFS and an acceptable safety profile when used in a Phase 3 trial for advanced metastatic non-small cell lung cancer following a dose-dense strategy. A more frequent assessment interval of 8 weeks seems to support this tolerability.

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What does selpercatinib usually treat?

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Selpercatinib is highly effective in adults with RAS-mutant NSCLC who do not have an activating mutation in the K-RAS or PIK3CA gene. It is generally well tolerated, and responses are durable and durable.

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

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The average age of patients diagnosed with carcinoma, non-small-cell lung, was 59 years in 1998. The average age for diagnoses of small cell carcinoma was 32 years and the average for large cell carcinoma was 62 years. The average age for patients with squamous cell carcinoma was 50 years and patients with adenocarcinoma averaged 63 years in 1998. Gender had no significance for overall age at diagnosis. Onset was earlier in women than men.

Unverified Answer

Is selpercatinib safe for people?

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Selpercatinib is well tolerated and efficacious in the first- to second-line setting in subjects with advanced NSCLC. Further phase 2 studies of sepercatinib are warranted.

Unverified Answer
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