Study of platinum, pemetrexed, atezolizumab and bevacizumab combination in patients with advanced non-small cell lung cancer who have EGFR, ALK or ROS1 mutations and progressed after targeted therapy

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What is this study about?

This study focuses on patients with non-squamous non-small cell lung cancer (stage IIIB/IV) who have specific genetic changes including EGFR mutations, ALK rearrangement, or ROS1 fusion, and whose disease has progressed after previous targeted treatments. The study will test a combination of several cancer medicines: platinum-based chemotherapy (cisplatin or carboplatin), pemetrexed, atezolizumab, and in some cases, bevacizumab.

The main purpose is to determine how well this combination of medications works in treating the cancer, particularly by measuring how many patients respond to the treatment after 4 cycles. The study will look at two separate groups of patients – one group receiving bevacizumab and another group not receiving it – to better understand the effectiveness of different drug combinations.

During the study, participants will receive the medications through intravenous infusion. The treatment can continue for up to 36 months, depending on how well it works and how well it is tolerated. Throughout the study, patients will have regular check-ups to monitor their response to treatment and any side effects. The study will also track how long patients live without their disease getting worse and measure changes in cancer-related symptoms.

1 Initial treatment phase

You will receive a combination of medications through intravenous infusion. The treatment consists of four medications:

Cisplatin or Carboplatin (platinum-based medication)

Pemetrexed

Atezolizumab

Bevacizumab (if eligible)

This initial phase consists of 4 treatment cycles

2 Treatment administration

Each medication will be administered through an intravenous line (directly into your vein)

The medications will be given as a solution that is slowly infused into your bloodstream

Medical staff will monitor your condition during the infusion process

3 Response evaluation

After 4 cycles of treatment, your response to therapy will be evaluated

The evaluation includes imaging tests to measure if the tumor has decreased in size

Your doctor will use specific criteria called RECIST to determine if the treatment is working

4 Ongoing monitoring

Regular assessments will check for any side effects

Your lung-related symptoms will be monitored using specific questionnaires

Additional scans and tests will be performed to track the progress of your treatment

5 Follow-up period

After completing treatment, you will need to continue using appropriate contraception for at least 5 months following the last dose of atezolizumab or 6 months after the last dose of chemotherapy

Your health status will continue to be monitored after treatment completion

Who Can Join the Study?

  • Age 18 years or older
  • Must have a diagnosis of stage IIIB/IV non-squamous non-small cell lung cancer confirmed by tissue examination
  • Physical ability score (ECOG) must be 0 or 1, meaning you must be able to perform daily activities with minimal assistance
  • If you have received previous cancer treatments, there must be at least 6 months break since the last treatment
  • If you have brain metastases (cancer spread to brain), they must be:
    • Not causing symptoms
    • Located only in specific brain areas
    • Not requiring steroid treatment
  • Must have measurable disease that can be evaluated using specific measurement criteria (RECIST v1.1)
  • Blood tests must show:
    • Adequate white blood cell counts
    • Adequate platelet levels
    • Adequate hemoglobin levels
    • Normal liver function tests
    • Normal kidney function
  • Must have specific genetic changes in your cancer:
    • EGFR mutation with previous treatment failure, or
    • ALK fusion with previous treatment failure, or
    • ROS1 fusion with previous treatment failure
  • Must agree to use effective birth control methods during treatment and for several months after
  • Must sign an informed consent form
  • Must have health insurance or social security coverage

Who Cannot Join the Study?

  • History of untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with immunotherapy (treatments that help your immune system fight cancer)
  • Active or chronic hepatitis B or C infection
  • Autoimmune diseases (conditions where your immune system attacks your own body)
  • Significant heart conditions or uncontrolled high blood pressure
  • History of bleeding disorders or current use of blood-thinning medications
  • HIV infection or AIDS
  • Active infections requiring systemic treatment
  • Other active cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Pregnancy or breastfeeding
  • Known allergies to any of the study medications
  • Major surgery within 4 weeks before starting the study
  • Participation in another clinical trial within 30 days
  • Serious medical conditions that could interfere with study participation
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier Universitaire De La Reunion St Denis France
Hospital Foch Suresnes France
CHU Gabriel-Montpied Clermont Ferrand France
Hopital D’Instruction Des Armees Percy Clamart France
Centre Hospitalier Universitaire Rouen Rouen France
HIA Sainte Anne Toulon France
Centre Paul Strauss STRASBOURG, Alsace France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Bretagne Atlantique Vannes France
Centre Francois Baclesse Caen France
Hôpital Pontchaillou-CHU Rennes Rennes France
Centre d’Investigation Clinique de Lyon – CIC1407 – Hôpital Louis Pradel Bron France
Calujm Lokx Bpzrby Lyon France
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Cesqnu Hkgxarhgyca Rmdommuv Dopnybiwaysvnf Angers France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
15.10.2019

Trial locations

Carboplatin is a chemotherapy medication used to treat various types of cancer. It belongs to a group of drugs called platinum-based chemotherapy. It works by interfering with cancer cell DNA, preventing cancer cells from growing and dividing.

Cisplatin is another platinum-based chemotherapy drug that works similarly to carboplatin. It is used to treat different types of cancer by damaging the DNA of cancer cells, which prevents them from multiplying.

Pemetrexed is a chemotherapy medication that blocks substances needed by cancer cells to grow. It is specifically used to treat non-small cell lung cancer and works by preventing cancer cells from making new DNA and proteins.

Atezolizumab is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that prevents immune cells from attacking cancer cells, allowing your body’s natural defenses to work better against the cancer.

Bevacizumab is a targeted therapy that works by blocking the growth of new blood vessels that feed tumors. By preventing these blood vessels from forming, it helps to slow or stop tumor growth by cutting off the tumor’s blood supply.

Erlotinib is a targeted therapy medication that works by blocking specific proteins that tell cancer cells to grow and divide. It is specifically used in patients with certain genetic mutations in their lung cancer.

Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms in the tissues outside the lungs’ air sacs. It develops when healthy cells in the lung tissue develop genetic changes and grow uncontrollably, forming a tumor. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease can affect different types of cells in the lung, with adenocarcinoma being one of the most common subtypes. The condition can spread from its original location to nearby tissues and other parts of the body.

Trial ID:
2024-516201-23-00
Protocol code:
GFPC 06-2018
NCT ID:
NCT04042558
Trial Phase:
Therapeutic exploratory (Phase II)

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