Study of Eftilagimod Alfa with Pembrolizumab and Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as advanced/metastatic non-small cell lung cancer (NSCLC). The study is testing a new drug called eftilagimod alfa, also known as efti, in combination with other treatments that are already available, such as pembrolizumab and chemotherapy. Pembrolizumab is a medication that helps the immune system fight cancer, and chemotherapy is a common treatment that uses drugs to kill cancer cells.

The purpose of this study is to compare the effectiveness of the combination of efti, pembrolizumab, and chemotherapy against the standard treatments currently used for this type of lung cancer. Participants in the study will receive either the new combination of treatments or the standard treatments. Some participants may receive a placebo, which looks like the treatment but does not contain any active medication. The study will be conducted over a period of time, and participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will undergo various assessments to track their health and the progress of their cancer. These assessments will help researchers understand how well the new treatment combination works compared to the standard treatments. The study aims to provide valuable information that could lead to improved treatment options for patients with advanced/metastatic non-small cell lung cancer.

1 initial treatment phase

The trial begins with the administration of the new drug eftilagimod alfa (also known as efti) in combination with pembrolizumab and chemotherapy. Eftilagimod alfa is given as a solution for injection under the skin (subcutaneous use).

Pembrolizumab, a medication that helps the immune system fight cancer, is administered as an intravenous infusion. This means it is given directly into a vein through a drip.

Chemotherapy drugs such as carboplatin, pemetrexed, cisplatin, and paclitaxel are also administered as intravenous infusions. These drugs are used to kill or stop the growth of cancer cells.

2 treatment schedule

The treatment is given in cycles. Each cycle lasts for a specific period, during which the medications are administered according to a set schedule.

The exact dosage and frequency of each medication depend on the specific protocol of the trial and the patient’s response to the treatment.

3 monitoring and assessments

Throughout the trial, regular monitoring and assessments are conducted to evaluate the patient’s response to the treatment.

This includes physical examinations, blood tests, and imaging studies to check the size and spread of the cancer.

The patient’s overall health and any side effects experienced are also closely monitored.

4 continuation or adjustment of treatment

Based on the results of the assessments, the treatment plan may be continued, adjusted, or stopped.

If the cancer responds well to the treatment, the same regimen may be continued. If there are significant side effects or if the cancer does not respond, adjustments may be made.

5 end of trial participation

The trial is expected to continue until 2029, but individual participation may end earlier depending on the patient’s response and health status.

At the end of participation, a final assessment is conducted to evaluate the overall outcome of the treatment.

Who Can Join the Study?

  • Willing to give written informed consent and follow the study rules.
  • Have a disease that can be measured, as determined by the study site.
  • Recovered from side effects of previous cancer treatments to a mild level or back to normal. Some exceptions apply, like mild nerve damage, hair loss, or liver issues due to cancer spread.
  • If you had major surgery before the study, you must have recovered well from it.
  • If you have hepatitis B, you must have been on antiviral treatment for at least 4 weeks and have no detectable virus in your blood before starting the study.
  • If you had hepatitis C, the virus must not be detectable in your blood at the start of the study, and you must have finished treatment at least 4 weeks before.
  • If you have HIV, you must be on treatment, have a well-controlled infection, and meet specific health criteria, like a certain level of immune cells and no recent serious infections.
  • Your organs must be working well, as defined in the study rules, with tests done within 10 days before starting the study.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be cured or treated with specific first-line therapies. You should not have had systemic treatment for advanced cancer, but previous radiation for advanced cancer is allowed.
  • Provide a sample of tumor tissue, either from a previous biopsy or a new one, that has not been treated with radiation.
  • Have a test result for a specific marker (PD-L1) from a central lab using an approved test.
  • Be at least 18 years old on the day you sign the consent form.
  • If you can produce sperm, agree to use contraception during the study and for a specified time after the last dose of study drugs, or abstain from sexual intercourse.
  • If you can become pregnant, you must not be pregnant, have a negative pregnancy test before starting the study, and use effective contraception or abstain from sexual intercourse during the study and for a specified time after the last dose of study drugs. You must also agree not to donate eggs during this time.
  • Have a good level of daily functioning, assessed within 7 days before starting the study.
  • Have an expected survival of more than 3 months.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied, which is called advanced/metastatic non-small cell lung cancer (NSCLC).
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group being studied.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent major surgery.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a mental health condition that might interfere with the study.
  • Patients who have a history of heart problems that might interfere with the study.
  • Patients who have a history of lung problems that might interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Pauls Stradins Clinical University Hospital Riga Latvia
KBC Zagreb Zagreb Croatia
Onco Clinic Consult S.A. Craiova Romania
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Robert Bosch Krankenhaus GmbH Stuttgart Germany
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
Azienda Ospedaliera S Maria Di Terni Terni Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Azienda Ospedaliera Di Perugia Perugia Italy
Az Maria Middelares Gent Gent Belgium
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
University Hospital St Marina Varna Varna Bulgaria
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Oncolab S.R.L. Craiova Romania
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Medicover S.R.L. Bucharest Romania
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Klinikum St Marien Amberg Amberg Germany
Ip Clinic Sp. z o.o. Lodz Poland
Instytut Msf Sp. z o.o. Lodz Poland
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
AORN San Giuseppe Moscati Avellino Avellino Italy
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte Bulgaria
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Complex Oncology Center Ruse EOOD Ruse Bulgaria
MBAL Serdika Ltd. Sofia Bulgaria
Überörtliche Gemeinschaftspraxis für Hämatologie und Onkologie (GEHO) Munster Germany
Bioclinic S.A. Thessaloniki Greece
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
General University Hospital Of Larissa Larissa Greece
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
University Of Debrecen Debrecen Hungary
Clinical Medical Center Osijek Osijek Croatia
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
General University Hospital Of Patras Patras Greece
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Multiprofile Hospital For Active Treatment Dobrich AD Dobrich Bulgaria
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
St. Luke’s Hospital S.A. Thessaloniki Greece
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Beaumont Hospital Dublin Ireland
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Metropolitan Hospital Athens Greece
Vgdmaeaqk idozdgrt Vbvaskgh uddsvvirwcod lrcyaeknt Sxjsuaus kpwaipt fanhndzc Nfghfqldhzpw vstzd cobybph Vilnius Lithuania
Csnd Ufeocyylib Hqqntqws Cork Ireland
Uebjxrzoggriazbqzitiy Aidehwtw Augsburg Germany
Sufaybrj Pvrhsafvj Smx z oenr Gdynia Poland
Lfeeibeq Swno Lisbon Portugal
Idgjlsacj Ohbwpponxk Dcc Rtmafl Sqdl Barcelona Spain
Ptli Tegqw Hjqunfvv Uqtvrdxizosd Sabadell Spain
Lxwad Gbeirsf Hjkiqnva Ow Ahfagp Athens Greece
Uprvczthqa Hdrmeomd Cmkpfsj Cologne Germany
Rgsat Aqdbjhzg kxlijjsj uimrencisisez shbozeqh Sio Riga Latvia
Afzibs Mhckqhn Cmepcs Svyx Thessaloniki Greece
Nneocnoj Isbulyka Ovmblzpel Icg Mwwke Sytzhfhwihyotwzwvzdbjlrrommq Idjqkvzk Bvdybspk Cracow Poland
Gzguvu Unlmystvbf Fctmdtbnc Frankfurt Germany
Akbocei Uaw Iazig Dw Rmlgnt Emlqqo Reggio Emilia Italy
Hgijarcr Dr Ly Syump Cxfh I Sntd Pig Barcelona Spain
Ucqdukmthj Ow Aiklboc Edegem Belgium
Islepcdt Cebyoj Dmilatonzivfjgzjq L'hospitalet De Llobregat Spain
Pwrdzsjaxof Lyiobhhk &etswdarokuasqkjlont Rpccu Ksesjjoqcfs Konin Poland
Hevgdsgi Vnem dfvrziug Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2025
Belgium Belgium
Not recruiting
01.04.2025
Bulgaria Bulgaria
Not recruiting
01.04.2025
Croatia Croatia
Not recruiting
01.04.2025
Germany Germany
Not recruiting
01.04.2025
Greece Greece
Not recruiting
01.04.2025
Hungary Hungary
Not recruiting
01.04.2025
Ireland Ireland
Not recruiting
01.04.2025
Italy Italy
Not recruiting
01.04.2025
Latvia Latvia
Not recruiting
01.04.2025
Lithuania Lithuania
Not recruiting
01.04.2025
Poland Poland
Not recruiting
01.04.2025
Portugal Portugal
Not recruiting
01.04.2025
Romania Romania
Not recruiting
01.04.2025
Spain Spain
Not recruiting
01.04.2025

Trial locations

Eftilagimod alfa is an experimental medication being studied for its potential to help the immune system fight cancer. It works by activating certain immune cells, which may enhance the body’s ability to attack cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced lung cancer.

Pembrolizumab is a medication that helps the immune system recognize and attack cancer cells. It is known as a PD-1 antagonist, which means it blocks a specific protein on immune cells that can prevent them from attacking cancer. By blocking this protein, pembrolizumab can help the immune system better target and destroy cancer cells.

Chemotherapy refers to a group of medications used to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to see if the combination can be more effective in treating advanced lung cancer. Chemotherapy works by targeting rapidly dividing cells, which include cancer cells, to reduce the size of tumors and slow the progression of the disease.

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its ability to spread to other parts of the body. It is termed “non-small cell” because the cancer cells are larger than those found in small cell lung cancer. In its advanced or metastatic stage, the cancer has spread beyond the lungs to other organs. The progression of the disease can vary, but it often involves the growth of tumors in the lungs and potentially in other areas such as the bones, brain, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The disease is typically diagnosed through imaging tests and biopsy, and its progression is monitored through regular medical evaluations.

Trial ID:
2024-513621-23-00
Protocol code:
TACTI-004
Trial Phase:
Therapeutic confirmatory (Phase III)

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