What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC), including those similar to the combination of hSTC810 and Paclitaxel, often result in a range of side effects. Paclitaxel is known to cause neuropathy, neutropenia, fatigue, and myalgias. Other chemotherapy agents like etoposide and cisplatin can lead to additional side effects such as nausea, vomiting, hair loss, and increased risk of infection due to bone marrow suppression. Patients may also experience anemia and thrombocytopenia. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including chemotherapeutic agents and combination therapies. Paclitaxel, a microtubule-stabilizing agent, has shown efficacy in treating relapsed SCLC, often used in later-line settings. Other approved treatments include topotecan, a camptothecin, and lurbinectedin, which are used for relapsed or refractory SCLC. Additionally, platinum-based chemotherapies such as cisplatin and etoposide are commonly used in combination regimens for initial treatment. Immune checkpoint inhibitors like atezolizumab have also been approved for extensive-stage SCLC in combination with chemotherapy.

What other types of research exist?

Promising novel alternatives for Small Cell Lung Cancer (SCLC) patients in 2024 include: 1) Atezolizumab, an immune checkpoint inhibitor targeting PD-L1, which has shown efficacy in combination with chemotherapy for extensive-stage SCLC. 2) Lurbinectedin, a transcription inhibitor approved for relapsed SCLC, which has demonstrated significant clinical activity. 3) Rovalpituzumab tesirine, an antibody-drug conjugate targeting DLL3, which is being investigated for its potential in SCLC treatment. These therapies offer different mechanisms of action compared to hSTC810 and Paclitaxel, providing new avenues for treatment.

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Monoclonal Antibodies

hSTC810 + Paclitaxel for Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by STCube, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed SCLC

R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug (hSTC810) combined with an existing chemotherapy drug (paclitaxel) in patients whose lung cancer has returned or did not respond to previous treatments. The goal is to determine if this combination is safe and effective. Paclitaxel is a well-known chemotherapy drug used to treat lung cancer and has been used in various combinations to improve treatment outcomes and survival times.

Who is the study for?

This trial is for adults over 18 with small cell lung cancer that has come back or didn't respond to platinum-based chemo. They should have a life expectancy of at least 3 months, be able to understand the study and agree to use contraception. They must have at least one tumor that can be measured and be in fairly good health (ECOG PS of 0 or 1).

What is being tested?

The trial is testing two different doses of hSTC810 combined with Paclitaxel in patients whose extensive stage small cell lung cancer has relapsed or hasn't responded after initial treatment. The goal is to see how safe this combination is and how well it works.

What are the potential side effects?

Possible side effects from hSTC810 and Paclitaxel may include allergic reactions, nerve damage causing pain or numbness, muscle aches, hair loss, nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer diagnosis was confirmed through lab tests.

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My small cell lung cancer returned or worsened after platinum-based treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression Free Survival (PFS) rate

Secondary study objectives

Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)

Area under the concentration-time curve from 0 to 21 days (AUC0-21)

Clinical Benefit Rate (CBR)

+8 more

Awards & Highlights

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: hSTC810 800 mg + PaclitaxelExperimental Treatment1 Intervention

hSTC810 800 mg will be administered with a standard dose of paclitaxel

Group II: hSTC810 400 mg + PaclitaxelExperimental Treatment1 Intervention

hSTC810 400 mg will be administered with a standard dose of paclitaxel

0 / 4Eligibility 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

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy and immunotherapy. Chemotherapy agents like Paclitaxel stabilize microtubules, preventing cell division and leading to cancer cell death. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, boosts the immune system's ability to recognize and destroy cancer cells. These treatments are vital for SCLC patients due to the aggressive nature of the disease, necessitating effective systemic therapies to improve survival and quality of life.