What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include etoposide (VP-16) combined with platinum-based drugs like cisplatin or carboplatin. Etoposide can cause myelosuppression, alopecia, nausea, vomiting, and mucositis. Platinum-based drugs are associated with nephrotoxicity, ototoxicity, and peripheral neuropathy. Immune checkpoint inhibitors such as atezolizumab, used with chemotherapy, can lead to immune-related adverse events like pneumonitis, colitis, and hepatitis. Trilaciclib, used to mitigate myelosuppression, may cause fatigue, hypocalcemia, hypokalemia, and hypophosphatemia.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that are similar to Etoposide (VP-16), a Topoisomerase II Inhibitor and CYP4503A4 substrate. Notably, the combination of Etoposide with platinum-based drugs like cisplatin or carboplatin has been a standard regimen. More recently, immune checkpoint inhibitors such as atezolizumab and durvalumab have been approved for use in combination with Etoposide and platinum-based chemotherapy, showing improved survival outcomes. These approvals mark significant advancements in the treatment of SCLC, providing new options for patients beyond traditional chemotherapy.

What other types of research exist?

Promising novel alternatives to Etoposide for Small Cell Lung Cancer patients include: 1) Atezolizumab in combination with carboplatin and etoposide, which has shown improved overall survival and progression-free survival. 2) Durvalumab plus platinum-etoposide, which has also demonstrated improved survival outcomes. 3) Amrubicin, which has shown comparable activity to topotecan in relapsed SCLC. 4) Lurbinectedin, which is another option for relapsed SCLC with demonstrated efficacy.

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Topoisomerase I inhibitors

Etoposide for Small Cell Lung Cancer (Drugs-SNPs Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of Small Cell Lung Cancer (SCLC)

Suitable for enough lung tissue biopsy of SCLC

Must not have

Have more than one different kind of cancer at the same time

Serious Bleed Tendency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration at least 90 days

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial uses Etoposide to treat small cell lung cancer patients. It aims to understand how differences in two specific genes affect treatment success and safety. Researchers study these genes to find links between genetic differences and how patients respond to the drug.

Who is the study for?

This trial is for adults over 22 with small cell lung cancer who can undergo a biopsy and have their blood drawn. They must be able to sign consent, have measurable disease, good organ function and performance status. It's not for those with serious allergies to drugs, multiple cancers, severe bleeding risks or infections, pregnant or breastfeeding individuals.

What is being tested?

The study investigates how genetic differences (SNPs) in the topoisomerase II gene and CYP4503A4 gene affect the treatment outcomes and side effects of Etoposide in small cell lung cancer patients. The trial uses precise gene sequencing techniques.

What are the potential side effects?

Etoposide may cause low white blood cell counts (increasing infection risk), hair loss, nausea, vomiting, diarrhea or constipation. There might also be allergic reactions like rashes or more serious ones that could require immediate medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Small Cell Lung Cancer.

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My doctor can take a biopsy of my lung tissue.

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My lung cancer was confirmed through a tissue biopsy.

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have more than one type of cancer.

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I have a serious tendency to bleed.

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I am aware of the serious risks or side effects of the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration at least 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration at least 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration at least 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ETOPOSIDE - UsualExperimental Treatment1 Intervention

* Etoposide Injection * Chemotherapy * Etoposide Injection * Usual Approach Group

Group II: ETOPOSIDE - StudyExperimental Treatment1 Intervention

* Etoposide Capsule * Chemotherapy * Etoposide Capsule * Study Approach Group

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Etoposide, a topoisomerase II inhibitor, works by inducing DNA strand breaks during replication, leading to cell death, which is particularly effective in rapidly dividing cancer cells. Carboplatin, a platinum-based drug, forms DNA crosslinks that inhibit DNA synthesis and transcription, also resulting in cell death. These mechanisms are vital for Small Cell Lung Cancer patients due to the disease's rapid growth and early spread, making it highly responsive to treatments targeting DNA replication and repair.

Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.