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Iph5201

A new clinical trial is exploring the potential of combining IPH5201 with durvalumab and standard chemotherapy in treating early-stage non-small cell lung cancer (NSCLC). This study aims to assess the safety and effectiveness of this combination therapy as a neoadjuvant (before surgery) and adjuvant (after surgery) treatment for patients with resectable NSCLC at stages II to IIIA. The trial, known as MATISSE, offers hope for improving outcomes in early-stage lung cancer patients.

Table of Contents

What is IPH5201?

IPH5201 is a new drug being studied for the treatment of non-small cell lung cancer (NSCLC). It is being tested in combination with another drug called durvalumab (also known as MEDI4736 or IMFINZI) and standard chemotherapy[1]. This combination therapy is being investigated as a potential new treatment option for patients with early-stage NSCLC.

Target Condition: Non-Small Cell Lung Cancer

The clinical trial is focusing on patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer. NSCLC is a type of lung cancer that accounts for about 80-85% of all lung cancers. “Resectable” means that the cancer can be surgically removed, which is typically the case for early-stage lung cancers[1].

Treatment Approach

The treatment approach in this study involves two main phases:

  1. Neoadjuvant therapy: This is treatment given before surgery. Patients will receive IPH5201, durvalumab, and standard chemotherapy. The chemotherapy may include combinations like carboplatin/paclitaxel, pemetrexed/cisplatin, or pemetrexed/carboplatin[1].
  2. Adjuvant therapy: This is treatment given after surgery. Patients will receive IPH5201 and durvalumab[1].

This approach aims to shrink the tumor before surgery (neoadjuvant phase) and then prevent cancer recurrence after surgery (adjuvant phase).

Clinical Trial Details

The clinical trial, named MATISSE, is a Phase II study. It is described as an open-label, single-arm, multicenter study. Here’s what these terms mean:

  • Open-label: Both the researchers and patients know which treatment is being given.
  • Single-arm: All participants receive the same treatment; there is no control group.
  • Multicenter: The study is conducted at multiple hospitals or research centers[1].

Expected Outcomes

The researchers will be looking at several outcomes to determine if the treatment is effective and safe. These include:

  • Pathological Complete Response (pCR): This means there are no cancer cells found in the removed tumor tissue after surgery[1].
  • Major Pathological Response (mPR): This indicates a significant reduction in cancer cells in the removed tumor tissue[1].
  • Event-Free Survival (EFS) and Disease-Free Survival (DFS): These measure how long patients live without their cancer progressing or returning[1].
  • Overall Survival (OS): This measures how long patients live after starting the treatment[1].

Safety Monitoring

Patient safety is a crucial aspect of this clinical trial. The researchers will be closely monitoring for any side effects or complications. They will track:

  • Adverse events (AEs): Any unfavorable medical occurrences during the study.
  • Serious adverse events (SAEs): Any severe or life-threatening events[1].

Additionally, the researchers will be studying how the drugs interact in the body (pharmacokinetics or PK) and whether patients develop antibodies against the study drugs (anti-drug antibodies or ADA)[1].

Aspect Details
Study Type Phase II, multicenter, open-label, non-randomized
Participants Patients with resectable, early-stage (II to IIIA) non-small cell lung cancer (NSCLC)
Treatment Neoadjuvant: IPH5201 + durvalumab + standard chemotherapy
Adjuvant: IPH5201 + durvalumab
Primary Outcomes Pathological Complete Response (pCR), Adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcomes Event-Free Survival (EFS), Disease Free Survival (DFS), Surgical resection, Major Pathological Response (mPR), Objective Response Rate (ORR), Overall Survival (OS)
Follow-up Duration Up to approximately 2 years

FAQ

  • What is the purpose of the MATISSE clinical trial? The MATISSE trial aims to evaluate the safety and effectiveness of combining IPH5201 with durvalumab and standard chemotherapy in treating early-stage (II to IIIA) non-small cell lung cancer (NSCLC) patients before and after surgery.
  • Who is eligible to participate in this clinical trial? The trial is designed for untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).
  • What treatment will participants receive in this study? Participants will receive neoadjuvant therapy (before surgery) with IPH5201, durvalumab, and standard chemotherapy. After surgery, they will continue with adjuvant treatment (after surgery) using IPH5201 and durvalumab.
  • What are the primary outcomes being measured in this trial? The primary outcomes include the number of patients achieving pathological Complete Response (pCR) and the number of patients experiencing adverse events (AEs) and serious adverse events (SAEs).
  • How long will participants be followed in this study? Participants will be followed for up to approximately 2 years to assess outcomes such as Event-Free Survival (EFS), Disease-Free Survival (DFS), and Overall Survival (OS).

Ongoing Clinical Trials on Iph5201

  • Study of IPH5201 and Durvalumab for Pre- and Post-Surgery Treatment in Patients with Early-Stage Non-Small Cell Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Greece Hungary Poland

Glossary

  • Non-Small Cell Lung Cancer (NSCLC): A type of lung cancer that is the most common form, accounting for about 80-85% of all lung cancers. It grows and spreads more slowly than small cell lung cancer.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually before surgery, to shrink the tumor and make it easier to remove.
  • Adjuvant therapy: Additional treatment given after the primary treatment (usually surgery) to lower the risk of cancer coming back.
  • Pathological Complete Response (pCR): The absence of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with cancer drugs.
  • Event-Free Survival (EFS): The length of time after treatment during which no specified event (such as disease progression or recurrence) is detected.
  • Disease-Free Survival (DFS): The length of time after primary treatment ends that the patient survives without any signs or symptoms of that cancer.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Overall Survival (OS): The length of time from either the date of diagnosis or the start of treatment that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Anti-drug antibodies (ADA): Antibodies produced by the immune system in response to a therapeutic drug, which may affect the drug's effectiveness or cause side effects.

References

  1. https://clinicaltrials.gov/study/NCT05742607