All studies
Active not recruitingPHASE3INTERVENTIONAL

Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy

This study focuses on a type of advanced lung cancer called Non-Small Cell Lung Cancer (NSCLC), which is a common cause of cancer death. About half of patients with this cancer are aged 70 or older. While newer immune-based treatments have shown promise when added to standard chemotherapy, older adults haven't been widely included in previous studies. This trial aims to find out if adding an immunotherapy drug called Atezolizumab to the usual chemotherapy (Carboplatin and Paclitaxel) is safe and works well for people aged 70 to 89. The goal is to see if this combination treatment is as effective and tolerable for older adults as it is for younger patients.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Enrolment target
510
Start
23 Jul 2019
Estimated completion
01 Dec 2026

What is this study about?

Non-Small Cell Lung Cancer (NSCLC) is a very serious illness and unfortunately, it's the most common cause of death from cancer worldwide. As people are living longer, more and more often we see patients aged 70 and above diagnosed with this condition – making up about half of all cases. This is an important age group, and we need to make sure we're offering them the best possible care.

In recent years, new types of medicines called immunotherapies have shown real promise. They work by helping your body's own immune system fight cancer cells. When these immunotherapies are added to standard chemotherapy (which are powerful drugs that kill fast-growing cancer cells), they can sometimes improve how well people do. However, most studies that have looked at these new treatments didn't include many patients who were 75 or older. This means we don't fully understand if these treatments work as well or have the same side effects for older people as they do for younger adults.

This particular study wants to fill that gap. We are looking specifically at patients aged 70 to 89 with advanced NSCLC. They will receive the standard chemotherapy drugs, Carboplatin and Paclitaxel, along with a new immunotherapy called Atezolizumab. The main goal is to find out if this combination treatment is just as effective and safe for older patients as it has been shown to be in younger groups. This research is vital to ensure that everyone, regardless of age, can benefit from the latest cancer treatments.

Key takeaways

  • This study investigates a new treatment for advanced lung cancer in older adults.
  • It combines standard chemotherapy with an immunotherapy drug called Atezolizumab.
  • The focus is on patients aged 70 to 89, a group not well-represented in previous studies.
  • The goal is to determine if the combined treatment is safe and effective for this specific age group.
  • Participation involves regular hospital visits for treatment and monitoring.
  • You have the right to withdraw from the study at any time.

Who may be eligible?

This study is looking for patients aged between 70 and 89 years old who have advanced Non-Small Cell Lung Cancer. You would need to have cancer that has spread (stage IIIB, IIIC or IV) and can be measured on scans. It's important that you haven't received any previous treatment for your advanced cancer and generally feel well enough to participate.

To join, you'll need to sign a consent form, show that your kidneys, liver, and blood counts are working well enough, and have a reasonable life expectancy. If you're a man who could father a child, you'd also need to agree to use effective contraception during the study and for 6 months afterwards.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 70 and 89 years old?
  2. Have you been diagnosed with advanced Non-Small Cell Lung Cancer that has spread?
  3. Have you not had any previous drug treatments for your advanced cancer?
  4. Are you generally feeling well enough for treatment (as assessed by your doctor)?
  5. Do your latest blood tests for your kidneys, liver, and blood counts show healthy levels?
  6. Are you able to attend regular hospital visits?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital for checks and treatments. You will receive standard chemotherapy (Carboplatin and Paclitaxel) combined with the immunotherapy drug Atezolizumab. The medical team will monitor you closely to see how you are responding to the treatment and to manage any side effects. You'll have various tests, including blood checks and scans, to keep an eye on your health and the cancer. The total duration of your participation, including follow-up, will be determined by the study protocol, but the treatment itself will continue as long as it is helping you and you are tolerating it well.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit could be access to a new treatment combination that might be more effective than standard care for your type of cancer. However, there are also risks, as all medications can have side effects. Chemotherapy and immunotherapy can cause various side effects, which the medical team will discuss with you in detail. Your safety and well-being are paramount, and you would have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (68)

  • Abbeville - CH
    Verified postcode
    Abbeville, France
  • Aix-en-Provence - CH
    Verified postcode
    Aix-en-Provence, France
  • Annemasse - CH
    Verified postcode
    Ambilly, France
  • Metz - Thionville CHR
    Verified postcode
    Ars-Laquenexy, France
  • Auxerre - CH
    Verified postcode
    Auxerre, France
  • Avignon - Institut Sainte-Catherine
    Verified postcode
    Avignon, France
  • Avignon - CH
    Verified postcode
    Avignon, France
  • Bayonne - CH
    Verified postcode
    Bayonne, France
  • Besançon - CHU
    Verified postcode
    Besançon, France
  • Bobigny - APHP - Hôpital Avicenne
    Verified postcode
    Bobigny, France
  • Bordeaux - CHU Hôpital Haut-Lévèque
    Verified postcode
    Bordeaux, France
  • Bordeaux - Polyclinique Nord
    Verified postcode
    Bordeaux, France

Common questions

What is Non-Small Cell Lung Cancer?

It's the most common type of lung cancer. This study focuses on advanced cases where the cancer has spread.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What are Carboplatin and Paclitaxel?

These are standard chemotherapy drugs commonly used to treat lung cancer. They work by killing cancer cells.

Why is this study only for people aged 70-89?

Previous studies haven't included many older adults, so this research aims to understand if these new treatments are safe and effective specifically for this age group.

Will I definitely get the new drug?

This study tests a treatment combination. You would receive both the standard chemotherapy and the immunotherapy drug, Atezolizumab.

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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