Etoposide for Small Cell Lung Cancer

(Drugs-SNPs Trial)

Not currently recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Must be taking: Etoposide

Must not be taking: Other anti-cancer therapies

Disqualifiers: Pneumonectomy, Pregnancy, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the drug Etoposide works for people with small cell lung cancer, focusing on how genetic differences might affect its effectiveness and side effects. Researchers will compare two groups using different types of Etoposide capsules to gather results. Candidates may qualify if they have a clinical diagnosis of small cell lung cancer and can undergo a lung tissue biopsy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on other anti-cancer therapies that cannot be stopped, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Etoposide, a drug used to treat small cell lung cancer, is both safe and effective. In one study, patients who took Etoposide with another drug achieved better treatment results while maintaining a good safety record. Another study found that Etoposide, when combined with other chemotherapy drugs, was safe for patients receiving treatment for the first time.

However, like many cancer treatments, Etoposide can cause side effects. One study reported that patients experienced a drop in a type of white blood cell, called neutropenia, but this did not worsen over time. These side effects are common with chemotherapy and can usually be managed with medical care.

Etoposide is also approved for treating other types of cancer, indicating its safety. Overall, many patients tolerate Etoposide well, but monitoring for any side effects remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about these treatments because Etoposide capsules, used in this trial, come from a unique source. Unlike the standard Etoposide treatments for small cell lung cancer, which are typically made in different regions, one arm of this trial uses Etoposide capsules imported from China. This could potentially offer differences in efficacy or safety profiles. Additionally, both treatment arms focus on distinct approaches – one being a "Study Approach Group" and the other a "Usual Approach Group" – allowing researchers to explore varied treatment strategies. These variations might reveal new insights into optimizing Etoposide’s effectiveness against small cell lung cancer.

What evidence suggests that Etoposide could be an effective treatment for small cell lung cancer?

Research has shown that etoposide is a promising treatment for small cell lung cancer. In this trial, participants will receive either the China Import Etoposide Capsule or the usual Etoposide Capsule. Studies indicate that when used alone, etoposide can help 15% to 84% of patients by shrinking their cancer or stopping its growth. One study found that 60% of patients who took etoposide in pill form had a positive response. For some, these benefits lasted several months, aiding in disease management. These findings suggest that etoposide is effective for many people with small cell lung cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

HAN XU, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Small Cell Lung Cancer.

Sign an informed consent form

I am willing to have my blood drawn for tests.

Exclusion Criteria

I have more than one type of cancer.

The prohibition of drug products

Have no therapeutic effects

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy with Etoposide capsules and undergo SNP genotyping

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Etoposide

Trial Overview 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.

How Is the Trial Designed?

Group I: ETOPOSIDE - Usual Experimental Treatment 1 Intervention

* Etoposide Capsule * Chemotherapy * Etoposide Capsule * Usual Approach Group

Group II: ETOPOSIDE - Study Experimental Treatment 1 Intervention

* China Import Etoposide Capsule * Chemotherapy * China Import Etoposide Capsule * Study Approach Group

Etoposide is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Approved in European Union as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Approved in Canada as Etoposide for:

• Testicular cancer
• Small cell lung cancer
• Non-Hodgkin lymphoma
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

2,400+

Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

4

Recruited

1,200+

UnitedHealthcare

Collaborator

Trials

5

Recruited

594,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/1845846/

Current status of etoposide in the management of small cell ... Single-agent etoposide achieves overall response rates ranging from 15% to 84%, depending on the schedule of drug administration and the characteristics of the ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.1986.4.6.982

Etoposide (VP-16) and cisplatin in previously treated small- ... We treated 29 patients with relapsed SCLC with this combination and found only a 12% response rate. The discrepancy between our results and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939641124000651

Preparation of etoposide liposomes for enhancing ... After intravenous injection, VP16-LPs enhanced antitumor effects on small cell lung cancer and reduced toxicity of drugs compared with marketed VP16 injection.

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)64867-2/fulltext

Chronic oral etoposide in small-cell lung cancer Among 25 evaluable pts, 60% (95% CI: 39%–79%) overall response, 144 and 217 days of median PFS and survival. Dose-limiting non-cumulative neutropenia of high ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/2981293/

an effective treatment for relapse in small-cell lung cancer In six (8%) patients, a complete response (CR) was achieved and in 37 (47%), there was a partial response (PR). The median duration of response for responding ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8661205/

Etoposide plus cisplatin chemotherapy improves the ... Etoposide plus cisplatin chemotherapy improves the efficacy and safety of small cell lung cancer ... small cell lung cancer: a phase II clinical trial.

7. clinical-lung-cancer.com clinical-lung-cancer.com/article/S1525-7304(25)00164-0/fulltext

Durvalumab Plus Platinum-Etoposide in Extensive-Stage ... A number of meta-analyses have investigated outcomes to immunotherapy according to sex, across multiple tumor types including lung cancer, ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8525

Safety and efficacy of QL1706 plus carboplatin/etoposide ... QL1706 plus EC chemotherapy showed tolerable safety profile and promising efficacy as first-line treatment for pts with ES-SCLC.

9. chemoexperts.com chemoexperts.com/etoposide-vp-16-sclc.html

Etoposide (VP-16) for Small Cell Lung Cancer (SCLC) Etoposide is used to slow tumor growth and alleviate symptoms of lung cancer. It is not commonly given with the goal of cure.