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Active not recruitingPHASE3INTERVENTIONAL

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

This study is for people with advanced non-small cell lung cancer (NSCLC) where previous treatments, including immunotherapy and chemotherapy, have stopped working. Researchers want to find out if adding new medications, cobolimab and dostarlimab, to a standard chemotherapy drug called docetaxel, is more effective than docetaxel alone, or docetaxel plus just dostarlimab. This is an important step in finding better treatments for NSCLC that has become harder to treat. The study will involve different groups of patients receiving different combinations of these drugs to compare their effects.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
758
Start
08 Dec 2020
Estimated completion
30 Mar 2027

What is this study about?

This study is looking for new and better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC). This is the most common type of lung cancer. Specifically, it focuses on patients whose cancer has unfortunately progressed, meaning it has grown or spread, even after they've already received standard treatments like chemotherapy and a type of immunotherapy (anti-PD-(L)1 therapy).

The main aim of this study is to compare different combinations of medicines. Patients will be divided into groups to receive one of three treatment approaches: (1) a new drug called cobolimab, combined with dostarlimab and docetaxel; (2) dostarlimab combined with docetaxel; or (3) docetaxel alone. Docetaxel is a standard chemotherapy drug. The researchers want to see if adding one or both of the new drugs to docetaxel makes the treatment more effective in shrinking the cancer or slowing its growth.

This is a 'Phase 3' study, which means it's one of the final steps in testing new treatments before they might become widely available. It's an 'open-label' study, meaning that both the patients and the doctors will know which treatment combination is being given. By carefully comparing these different treatment groups, the study hopes to identify a more effective treatment option for patients with advanced NSCLC that has become resistant to previous therapies.

Key takeaways

  • This study is for advanced non-small cell lung cancer that has progressed despite prior treatments.
  • It's comparing different drug combinations: cobolimab + dostarlimab + docetaxel, dostarlimab + docetaxel, and docetaxel alone.
  • The goal is to find more effective treatments for hard-to-treat lung cancer.
  • Regular hospital visits, tests, and scans will be part of participation.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you must have advanced non-small cell lung cancer that has been confirmed by a doctor, and your cancer must have progressed despite previous treatment. This previous treatment should have included both chemotherapy and a type of immunotherapy. You must be well enough to take part, meaning you can carry out most of your daily activities, and doctors will check your general health, including your organ function, to make sure you are suitable.

You also need to have areas of cancer that can be measured by scans. If you have a specific type of lung cancer called squamous cell carcinoma, you don't need to have had specific genetic tests. However, if you have non-squamous lung cancer, your doctors will need to confirm that your cancer doesn't have certain genetic changes (called EGFR, ALK, or ROS-1 mutations) that would mean other treatments are more appropriate for you.

There are also reasons why you might not be able to join the study. For instance, if you've had a serious side effect from a previous immunotherapy that led to you stopping it permanently, or if you've already had certain other types of immunotherapy or chemotherapy drug (like docetaxel) for your advanced cancer. Also, if your cancer has shown signs of growing very quickly after recent treatments, you might not be eligible. This study is for adults aged 18 years and older, regardless of gender.

Quick self-check
  • Do I have advanced non-small cell lung cancer?
  • Has my cancer progressed after receiving both previous chemotherapy and immunotherapy?
  • Am I generally well enough to participate in a clinical study? (e.g. Can I perform most daily activities?)
  • Have I been tested for specific genetic mutations (EGFR, ALK, ROS-1) if I have non-squamous lung cancer, and do not have them?
  • Am I over 18 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are eligible and choose to take part in this study, you will be assigned to one of three different treatment groups. You will receive a combination of medicines through infusions (into a vein) over a period of time. You will have regular hospital visits for your treatments, blood tests, and scans to monitor your health and how the cancer is responding to the treatment. The frequency of these visits and assessments will be explained in detail by the study team. You'll also be asked to provide a sample of your tumour tissue, either from a past biopsy or by having a new biopsy if needed. The total duration of your participation will depend on how you respond to the treatment and your health, but you will undergo regular follow-up for a period after treatment ends.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment combination that could be more effective for your cancer than standard options. However, there's no guarantee that the treatment will work for you, and it might not improve your condition. Like all medicines, the study drugs can have side effects, which could be mild or serious. The study team will explain all known potential risks and monitor you closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (163)

  • GSK Investigational Site
    Fountain Valley, United States
  • GSK Investigational Site
    Walnut Creek, United States
  • GSK Investigational Site
    Norwich, United States
  • GSK Investigational Site
    Washington D.C., United States
  • GSK Investigational Site
    Honolulu, United States
  • GSK Investigational Site
    Iowa City, United States
  • GSK Investigational Site
    Edgewood, United States
  • GSK Investigational Site
    Las Vegas, United States
  • GSK Investigational Site
    Mineola, United States
  • GSK Investigational Site
    New York, United States
  • GSK Investigational Site
    White Plains, United States
  • GSK Investigational Site
    Pittsburgh, United States

+151 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer?

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. This study focuses on advanced NSCLC that has progressed after initial treatments.

What does 'advanced' mean in this context?

'Advanced' means the cancer has spread beyond where it started in the lung, or it has returned despite previous treatments.

What are immunotherapy and chemotherapy?

Immunotherapy helps your body's immune system fight cancer, while chemotherapy uses strong drugs to kill cancer cells throughout the body.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctors will know which combination of medicines you are receiving.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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