#1 Clinical Trials Search in Europe

Study of Immunotherapy Combinations Including Zimberelimab for Patients With Advanced Non-Small Cell Lung Cancer

2 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for Advanced Non-Small Cell Lung Cancer, a type of lung cancer that has spread to other parts of the body. The study will explore various combinations of immunotherapy, which is a treatment that helps the body’s immune system fight cancer. The medications being tested include Zimberelimab (also known as AB122), Domvanalimab (AB154), and Quemliclustat (AB680). These treatments are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well these immunotherapy combinations work in treating the cancer and to assess their safety. Participants will receive the treatments over a period of time, and their response to the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study will also look at how the body processes these medications and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to provide valuable information on the effectiveness and safety of these new treatment combinations for people with advanced non-small cell lung cancer. The trial is expected to continue until March 2025, with recruitment starting in December 2023.

1 joining the study

Upon joining the study, a diagnosis of Stage IV metastatic non-small cell lung cancer is confirmed.

Eligibility is determined based on performance status, measurable lesions, and organ function.

2 initial assessment

An initial assessment is conducted to establish baseline health status.

This includes imaging tests and laboratory evaluations to measure target lesions and organ function.

3 treatment phase

The treatment phase involves receiving a combination of immunotherapy-based medications.

Medications such as cisplatin, pemetrexed, paclitaxel, docetaxel, carboplatin, zimberelimab, domvanalimab, quemliclustat, and paclitaxel albumin-bound are administered intravenously.

The specific combination and dosage depend on individual treatment plans.

4 monitoring and follow-up

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

This includes periodic imaging and laboratory tests to evaluate the size of lesions and overall health.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted.

This includes evaluating the objective response rate and any adverse events experienced during the trial.

6 post-trial follow-up

After the trial, follow-up visits may be scheduled to monitor long-term health outcomes.

These visits help in understanding the overall survival and progression-free survival rates.

Who Can Join the Study?

  • Must have a confirmed diagnosis of Stage IV metastatic Non-Small Cell Lung Cancer (NSCLC). This means the cancer has spread to other parts of the body.
  • Must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must have at least one measurable target lesion according to RECIST v1.1. This is a guideline used to measure how tumors respond to treatment.
  • Must have adequate organ and bone marrow function. This means the organs and bone marrow are working well enough to handle the treatment.
  • Must be willing to provide adequate tumor tissue. This means agreeing to give a sample of the tumor for study purposes.
  • Both male and female participants are eligible.
  • Participants from vulnerable populations are eligible. This means people who might need extra protection or care can also join.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Advanced Non-Small Cell Lung Cancer cannot participate.
  • Patients who have not reached the required age range for the study cannot participate.
  • Patients who are not able to understand or follow the study procedures cannot participate.
  • Patients who have a medical condition that makes it unsafe for them to receive the study treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a severe allergic reaction to similar treatments in the past cannot participate.
  • Patients who have an active infection that requires treatment cannot participate.
  • Patients who have a history of certain heart conditions cannot participate.
  • Patients who have a history of certain lung conditions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach Katowice Poland
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
Hospital Foch Suresnes France
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Hospital Quironsalud Malaga Malaga Spain
Micancer Center S.L.P. Barcelona Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Med Polonia Sp. z o.o. Poznan Poland
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital 9 De Octubre S.A. Valencia Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Sbkykimc Pextyxclh Snh z oxya Gdynia Poland
Hnykdqpn Uucvilxupxdoq Milaq Teiwogbx Terrassa Spain
Ixlifefh Rsktwwldz Pun Ll Swugrb Dzg Tkaeui Drgp Akrjsry Ipif Stxxhr Meldola Italy
Nlnzbzko Iyrutewt Oudlfkegy Ieo Mrgqw Sxnlqofeolmgbkhzhthfntkmdzsp Iucaqvlw Bkhfsbom Cracow Poland
Hmlijhwo Dl Lm Scoml Cwky I Sqle Pae Barcelona Spain

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
01.12.2023
Italy Italy
Not recruiting
01.12.2023
Poland Poland
Not recruiting
01.12.2023
Spain Spain
Not recruiting
01.12.2023

Trial locations

Investigated drugs:

Immunotherapy-based Combination Therapy is a treatment approach used in this clinical trial for patients with advanced non-small cell lung cancer. This therapy involves using medications that help the body’s immune system recognize and attack cancer cells more effectively. The goal is to improve the body’s natural defenses to fight the cancer, potentially leading to better outcomes for patients. The trial aims to evaluate how well this combination therapy works in shrinking tumors and how safe it is for patients to use.

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 relatively slow growth compared to small cell lung cancer. It is called “non-small cell” because the cancer cells are larger than those of small cell lung cancer. As the disease progresses, it can spread to other parts of the body, including the lymph nodes, bones, brain, and liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The disease is often diagnosed at an advanced stage when it has already spread beyond the lungs.

Trial ID:
2022-502916-35-01
Protocol code:
EDGE-Lung
NCT ID:
NCT05676931
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of MK-1084 plus durvalumab versus placebo plus durvalumab in patients with locally advanced KRAS G12C‑mutant non‑small cell lung cancer after chemoradiotherapy

    Recruiting

    3 1 1
    Investigated drugs:
    France Germany Greece Italy The Netherlands Poland +1

  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain