Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

19 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHU Croix Rousse-Lyon
Verified
Lyon, France
CHU Gabriel-Montpied
Verified
Clermont Ferrand, France

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Pemetrexed
An intravenously administered chemotherapy drug used primarily in the treatment of non-small cell lung cancer (NSCLC). This antifolate medication works by blocking several enzymes involved in purine and pyrimidine synthesis, thereby preventing cancer cell DNA replication and tumor growth. It belongs to the class of antimetabolite chemotherapy agents and is typically used in combination with platinum-based drugs for advanced stage non-squamous NSCLC.
Atezolizumab
An immunotherapy medication administered through intravenous infusion that helps the immune system fight cancer cells. It works by blocking the PD-L1 protein, which allows T-cells to detect and attack cancer cells more effectively. This monoclonal antibody belongs to the class of immune checkpoint inhibitors and is approved for treating various types of cancers, including non-small cell lung cancer.
Bevacizumab
An intravenous biologic medication that targets blood vessel growth in tumors. It works by blocking vascular endothelial growth factor (VEGF), effectively reducing blood supply to cancer cells and inhibiting tumor growth. This monoclonal antibody belongs to the class of anti-angiogenic agents and is commonly used in combination with other chemotherapy drugs for treating advanced non-small cell lung cancer.
Carboplatin
A platinum-based chemotherapy drug administered intravenously that interferes with cancer cell DNA, preventing cell division and tumor growth. It belongs to the platinum compounds class of chemotherapy medications and is often preferred over cisplatin due to its more favorable side effect profile, particularly in combination therapy for non-small cell lung cancer.
Cisplatin
A platinum-based chemotherapy medication given through intravenous infusion that works by forming cross-links in DNA, preventing cancer cell division and reproduction. It belongs to the platinum compounds class of chemotherapy drugs and is considered a standard treatment option in combination therapy for various types of cancer, including non-small cell lung cancer.

Investigated diseases

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.