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Study on Vudalimab or Pembrolizumab with Chemotherapy for Advanced Non-small Cell Lung Cancer Patients

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What is this study about?

The study explores treatments for an illness called advanced non-small cell lung cancer, a type of cancer affecting the lungs. This investigation focuses on how well two different medications work when combined with chemotherapy. The medications being tested are called vudalimab and pembrolizumab. Chemotherapy involves drugs administered to kill cancer cells and is a common treatment for cancer patients.

In this study, researchers aim to find out whether a combination of either vudalimab or pembrolizumab with chemotherapy is effective and safe for people with advanced non-small cell lung cancer. Vudalimab, listed with the code name XmAb20717, is being compared to pembrolizumab, a medication already used in cancer treatment. The study will use these drugs in combination with chemotherapy medicines like carboplatin and pemetrexed.

The main goal of the study is to determine which combination of drugs helps patients best in managing their cancer. Participants will receive the medications through an intravenous infusion, meaning the drugs will be delivered directly into their bloodstream. The study’s results will provide insights into the most effective treatment for patients with advanced non-small cell lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

Written informed consent is required to participate.

2 initial assessment

An initial assessment is conducted to evaluate health status and confirm the absence of certain genetic mutations.

Tests include imaging and laboratory evaluations to establish baseline health metrics.

3 treatment assignment

Participants are randomly assigned to one of two treatment groups: vudalimab with chemotherapy or pembrolizumab with chemotherapy.

The assignment determines the specific medications and treatment schedule.

4 treatment administration

Treatment involves intravenous infusions of the assigned medications.

Medications include carboplatin, pemetrexed, pembrolizumab, and vudalimab, administered according to the study protocol.

5 monitoring and follow-up

Regular monitoring is conducted to assess treatment effects and manage any side effects.

Follow-up visits include physical exams, imaging, and laboratory tests to track progress.

6 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate overall health and treatment outcomes.

Participants may be asked to continue follow-up visits to monitor long-term effects.

Who Can Join the Study?

  • Must be able to provide written consent to participate in the study.
  • Must be 18 years of age or older.
  • Must have a confirmed diagnosis of advanced non-small cell lung cancer that cannot be surgically removed or has spread to other parts of the body.
  • Must not have certain genetic changes in the cancer, specifically in the EGFR, ALK, or ROS1 genes, which are known to drive cancer growth.
  • Must not have other genetic changes for which there are approved targeted treatments available.
  • Must have a specific test result showing a PD-L1 level, which is a protein on cancer cells, between less than 1% and 49%.
  • Must not have received previous treatment for advanced or metastatic non-small cell lung cancer, except for certain treatments completed at least 12 months before the cancer spread.
  • Must have measurable cancer according to specific medical guidelines, even if the cancer was previously treated with radiation.
  • Must provide a sample of the tumor that was preserved in a specific way for testing.
  • Must have a performance status score of 0 or 1, which indicates the ability to carry out daily activities.
  • Must have a life expectancy of at least 3 months.
  • Must have adequate organ function, as shown by specific blood test results, including:
    • Hemoglobin level of at least 9 g/dL without recent blood transfusions.
    • A certain level of white blood cells called neutrophils.
    • A certain level of platelets, which help with blood clotting.
    • Liver function tests within specific limits, depending on whether the cancer has spread to the liver.
    • Normal thyroid function, with or without medication.
    • Kidney function as measured by creatinine clearance of at least 45 mL/min.
  • Women who can become pregnant must agree to use effective birth control and not breastfeed during the study and for a specified time after the last dose of study drugs.
  • Men must agree to use effective birth control and not donate sperm during the study and for a specified time after the last dose of study drugs.
  • Must be able and willing to follow the study schedule and complete the study requirements.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Advanced Non-small Cell Lung Cancer cannot participate.
  • Patients who have had a different cancer treatment recently may not be eligible.
  • Patients with certain medical conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend required visits may not be eligible.
  • Patients with a history of severe allergic reactions to similar medications may be excluded.
  • Patients who are currently participating in another clinical trial may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Netherlands Cancer Institute Amsterdam The Netherlands
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Lotus Med S.R.L. Bucharest Romania
Hospital Quironsalud Barcelona Barcelona Spain
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Med Polonia Sp. z o.o. Poznan Poland
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Jessa Ziekenhuis Hasselt Belgium
Oncomed S.R.L. Timisoara Romania
General University Hospital Of Patras Patras Greece
St. Luke’s Hospital S.A. Thessaloniki Greece
Avezjp Muqpdri Cutmhb Sczo Thessaloniki Greece
Nfyqfhcy Iwxacpqn Ouqsnxecm Ill Mkulz Sxqbyexugwnxgimnkhxbhdhydpee Ivmzjjol Bgotebwu Cracow Poland
Ibawoodt Csnpqf Dcwdakeunlqgfljkx L'hospitalet De Llobregat Spain
Fjsksvlgm Pgvm Lu Igqpvsxogmdes Bvabdwvjw Dqf Hefbkixj Usdqueertvbgr Ln Pzp Madrid Spain
Hpjigyzf Vnmm dqdbussk Barcelona Spain
Ufedrwdzwz Gxpupkk Hoqvkwpg Adbjaoq Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
19.05.2024
Greece Greece
Not recruiting
19.05.2024
Poland Poland
Not recruiting
19.05.2024
Portugal Portugal
Not recruiting
19.05.2024
Romania Romania
Not recruiting
19.05.2024
Spain Spain
Not recruiting
19.05.2024
The Netherlands The Netherlands
Not recruiting
19.05.2024

Trial locations

Investigated drugs:

Vudalimab is a medication being studied for its potential to treat advanced non-small cell lung cancer. It is being tested in combination with chemotherapy to see how safe and tolerable it is for patients. Researchers are also looking at how well it works compared to another treatment option.

Pembrolizumab is another medication used in this study. It is already known to help the immune system fight cancer cells. In this trial, it is combined with chemotherapy to see how effective it is as a first-line treatment for patients with advanced non-small cell lung cancer. The study aims to compare its effectiveness with the combination of vudalimab and chemotherapy.

Investigated diseases:

Advanced Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its advanced stage, meaning it has spread beyond the lungs to other parts of the body. It is the most common type of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors, which can invade nearby tissues and organs. Over time, these cancerous cells can enter the bloodstream or lymphatic system, spreading to distant parts of the body, a process known as metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing, which can worsen as the disease advances.

Trial ID:
2023-509644-10-00
Protocol code:
XmAb717-06
NCT ID:
NCT06173505
Trial Phase:
Human Pharmacology (Phase I) – Other

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