GSK5764227 for Small Cell Lung Cancer

Recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must not be taking: Antibody-drug conjugates

Disqualifiers: Complex SCLC, Cardiovascular disorders, Brain metastases, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 55 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, GSK5764227, to determine its effectiveness for people with small cell lung cancer (SCLC) that has recurred after treatment. The goal is to see if this drug works better than the current standard treatment, topotecan (a chemotherapy drug), by shrinking the cancer or extending patients' lives. Researchers aim to assess whether GSK5764227 is safe and has manageable side effects. Suitable candidates for this trial have lung cancer that has spread widely and have previously undergone a specific treatment, but their cancer returned. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to access potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that GSK5764227 has potential based on earlier studies. The FDA has granted it "breakthrough therapy designation," indicating early evidence of effectiveness in treating small cell lung cancer (SCLC). This status often suggests the treatment appears safe, but more information is needed for confirmation.

Previous trials tested GSK5764227 for safety and patient tolerance in various solid tumors. These studies provided insights into side effects and patient responses. Although specific safety details are not provided here, progression to a Phase 3 trial indicates it was generally well-tolerated in earlier tests.

In this trial, GSK5764227 is compared to topotecan, a standard SCLC treatment with a well-known safety record. Researchers will closely monitor participants to assess GSK5764227's effectiveness and safety. It is important to remember that all treatments, even those usually well-tolerated, can have side effects. Participants will be informed about these and monitored throughout the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

Researchers are excited about GSK5764227 for small cell lung cancer because it offers a unique approach compared to current treatments like chemotherapy and immunotherapy. GSK5764227 is an experimental drug that works by targeting specific pathways involved in cancer cell survival, potentially offering more precise action against the cancer cells. This could lead to improved outcomes by reducing the growth of cancer cells more effectively than current standard treatments. Additionally, this approach might result in fewer side effects, making it a promising option for patients who struggle with the harsh side effects of existing therapies.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that GSK5764227, a new medicine targeting the B7-H3 protein on cancer cells, may help treat small cell lung cancer (SCLC). In earlier studies, patients taking GSK5764227 lived without their cancer worsening for an average of 4.7 months. Additionally, 72.7% of patients did not experience cancer growth after three months. These findings suggest that GSK5764227 might slow cancer growth and spread. This trial compares GSK5764227 to topotecan, a standard treatment, to determine if it helps patients live longer and reduces cancer size. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed Small Cell Lung Cancer (SCLC). Participants should have experienced a return of their cancer after previous treatments. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

Inclusion Criteria

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

Has at least 1 target lesion per RECIST 1.1, as determined by the investigator

My lung cancer is confirmed to be extensive-stage small cell.

Exclusion Criteria

Known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study

Documented Hepatitis B or Hepatitis C

I haven't had significant bleeding or a tendency to bleed in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either GSK5764227 or topotecan to evaluate efficacy and safety in treating relapsed SCLC

Up to approximately 55 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 161 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK5764227
• Topotecan

Trial Overview The study tests GSK5764227, a new drug targeting proteins on cancer cells against the standard treatment topotecan. It aims to see if GSK5764227 can shrink or eliminate tumors and extend life expectancy compared to topotecan. Patients will be randomly assigned to one of these two treatments.

How Is the Trial Designed?

Group I: GSK5764227 Experimental Treatment 1 Intervention

Group II: Topotecan Active Control 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. onclive.com onclive.com/view/fda-grants-btd-to-gsk5764227-for-extensive-stage-small-cell-lung-cancer

FDA Grants BTD to GSK5764227 for Extensive-Stage ... Moreover, the median progression-free survival (PFS) was 4.7 months (95% CI, 1.4-not applicable) and the 3-month PFS rate was 72.7% (95% CI, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07099898

NCT07099898 | A Study of GSK5764227 in Participants ... This study specifically aims to evaluate how well GSK5764227 works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether GSK ...

3. curetoday.com curetoday.com/view/gsk-227-gets-fda-breakthrough-therapy-designation-for-es-sclc

GSK'227 Gets FDA Breakthrough Therapy Designation for ... GSK, in its news release, cited statistics that the five-year survival rate of extensive-stage small cell lung cancer is 3% and that the median ...

4. gsk.com gsk.com/en-gb/media/press-releases/b7-h3-targeted-antibody-drug-conjugate-receives-ema-priority-medicines-designation-in-relapsed-extensive-stage-small-cell-lung-cancer/

GSK's B7-H3-targeted antibody-drug conjugate, ... A Multicenter Study Assessing the Real-World Use and Effectiveness of First-Line Chemotherapy Plus Immunotherapy in Advanced Small-Cell Lung ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424009109

OA04.06 Efficacy and Safety of HS-20093 in Extensive ... HS-20093 showed encouraging efficacy in ES-SCLC. ORR was 61.3% for pts at 8.0 mg/kg dose and 50.0% for pts at 10.0 mg/kg dose. DCR, median DoR, median ...

6. gsk.com gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-breakthrough-therapy-designation/

GSK receives US FDA Breakthrough Therapy Designation ... Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS847

A phase 1 dose escalation/expansion study of ... The current study will evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of GSK'227 in patients with solid tumors, including GI cancers, ...

8. targetedonc.com targetedonc.com/view/gsk5764227-gains-fda-breakthrough-therapy-designation-in-es-sclc

GSK5764227 Gains FDA Breakthrough Therapy ... The FDA has granted GSK5764227 a breakthrough therapy designation for the treatment of extensive-stage small cell lung cancer.