Study of BNT327 with etoposide and carboplatin compared to atezolizumab with etoposide and carboplatin for patients with untreated extensive-stage small-cell lung cancer

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What is this study about?

This clinical trial is studying extensive-stage small-cell lung cancer in people who have not yet received treatment for their disease. Small-cell lung cancer is a type of lung cancer that grows and spreads quickly, and extensive-stage means the cancer has spread beyond one lung and nearby lymph nodes. The study will compare two different treatment approaches. One group will receive an investigational medicine called BNT327 combined with chemotherapy drugs etoposide and carboplatin. The other group will receive atezolizumab, which is an already approved medicine, combined with the same chemotherapy drugs etoposide and carboplatin. All medications in this study are given through an infusion into a vein. Some participants may also receive cisplatin as an alternative chemotherapy drug instead of carboplatin during the treatment period.

The purpose of this study is to compare how well BNT327 works compared to atezolizumab when each is given with chemotherapy, specifically by looking at how long participants live after starting treatment. The study will also examine how long participants live without their cancer getting worse, how many participants see their tumors shrink or disappear, and how long these responses last. Additionally, the study will monitor side effects and how the treatments affect quality of life and cancer-related symptoms such as coughing and shortness of breath.

This is a randomized study, which means participants will be assigned by chance to receive either BNT327 with chemotherapy or atezolizumab with chemotherapy. The study is double-blinded, meaning neither the participants nor their doctors will know which treatment group they are in during the study. Participants will receive treatment for up to 48 weeks or longer depending on how they respond to the treatment. Throughout the study, participants will have regular visits where their health, tumor size, and any side effects will be monitored through physical examinations, blood tests, imaging scans, and questionnaires about their well-being and symptoms.

1 Treatment assignment

Upon joining the trial, you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures fair distribution of participants.

One group will receive BNT327 combined with chemotherapy (etoposide and carboplatin). The other group will receive atezolizumab combined with the same chemotherapy drugs.

Neither you nor your doctor will know which treatment group you are in. This is called a double-blinded trial and helps ensure accurate results.

2 Induction period with combination treatment

You will receive treatment through intravenous infusion, which means the medication will be delivered directly into your vein.

The treatment consists of either BNT327 or atezolizumab combined with two chemotherapy drugs: etoposide and either carboplatin or cisplatin.

All medications will be administered as infusions into your vein during scheduled visits to the treatment facility.

This combination treatment phase will continue for a specified number of cycles as determined by the trial protocol.

3 Maintenance treatment phase

After completing the initial combination treatment phase, you will continue receiving either BNT327 or atezolizumab alone, without the chemotherapy drugs.

This maintenance treatment will be given through intravenous infusion at regular intervals.

The treatment will continue until your disease progresses, unacceptable side effects occur, or other reasons require stopping the treatment.

4 Regular monitoring and assessments

Throughout the trial, you will have regular medical examinations and tests to monitor your health and how the treatment is working.

Blood tests will be performed to check your blood cell counts, liver function, and kidney function.

Imaging scans will be conducted at scheduled intervals to assess your tumor size and whether the cancer has progressed.

You will be asked to complete questionnaires about your quality of life, physical functioning, and symptoms such as coughing, shortness of breath, and other lung cancer-related issues.

Any side effects or health changes you experience will be carefully recorded and assessed.

5 Contraception and reproductive precautions

If you are a woman of childbearing potential, you must use a highly effective form of contraception starting from your first visit and continuing until 6 months after your last dose of trial treatment, or 7 months after the last dose of cisplatin if you received it, whichever is later.

If you are a man who is sexually active with a female partner and have not had a vasectomy, you must use condoms and your partner must also use highly effective contraception during the same time period.

You must not donate or store sperm, eggs, or other reproductive cells for assisted reproduction purposes during the trial and for the same time period after your last treatment dose.

6 Follow-up after treatment

After you stop receiving trial treatment, you will continue to be monitored for your overall health and survival.

Information about any subsequent cancer treatments you receive after the trial treatment will be collected.

Your participation in the follow-up phase helps assess the long-term effectiveness of the treatment.

Who Can Join the Study?

  • You must be able to understand the study information and provide written agreement to participate before any study procedures begin.
  • If you are a woman who can become pregnant, you must have a negative pregnancy test within 7 days before starting the study treatment.
  • If you are a woman who can become pregnant, you must agree to use a highly reliable birth control method (a method that prevents pregnancy very effectively) from the screening visit until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • If you are a man who is sexually active with a woman who can become pregnant and you have not had a vasectomy (a surgical procedure that prevents a man from causing pregnancy), you must agree to use condoms and ask your partner to use a highly reliable birth control method from the screening visit until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • You must agree not to donate or store sperm, eggs, or other reproductive cells for the purpose of having children during the study, starting at screening and continuing until 6 months after your last dose of study treatment, or 7 months after the last dose of cisplatin if you receive it, whichever is later.
  • You must be willing and able to attend all scheduled visits, follow the treatment plan, complete all planned tests and assessments, and follow other study requirements and instructions.
  • You must be at least 18 years old at the time you agree to participate.
  • You must have extensive-stage small-cell lung cancer (a type of lung cancer that has spread beyond one lung) that has been confirmed by tissue or cell examination under a microscope.
  • You must not have received any previous treatment with medications that travel through your bloodstream to treat your extensive-stage small-cell lung cancer.
  • You must have at least one tumor that can be measured using imaging tests according to specific measurement guidelines called RECIST v1.1.
  • You must have an ECOG performance status (a measure of how well you can perform daily activities) of 0 or 1, meaning you are fully active or have some restrictions but can still perform light work.
  • You must weigh at least 40 kilograms (approximately 88 pounds).
  • You must have adequate blood cell counts, blood clotting ability, and proper functioning of your liver and kidneys as shown by laboratory tests.

Who Cannot Join the Study?

  • The study information does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
  • Without detailed exclusion criteria listed, patients interested in this study would need to have their individual medical situation reviewed by the research team to determine if they are suitable candidates
  • Generally, clinical trials may exclude patients based on factors such as other serious medical conditions, previous treatments, laboratory test results, or medications that could interfere with the study
  • The specific reasons for not being able to join this particular study have not been provided in the available trial information

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Universitaetsklinikum Aachen AöR Aachen Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
MD Anderson Cancer Center Madrid Spain
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
AORN San Giuseppe Moscati Avellino Avellino Italy
Micancer Center S.L.P. Barcelona Spain
Klinikverbund Allgaeu gGmbH Kempten (Allgau) Germany
Oncopremium Team S.R.L. Baia Mare Romania
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Pratia Hematologia Sp. z o.o. Katowice Poland
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Spitalul Clinic Coltea Bucharest Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario De Leon Leon Spain
Helios Universitaetsklinikum Wuppertal Wuppertal Germany
Kaiserswerther Diakonie Duesseldorf Germany
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Hospital Universitario Virgen De Valme Sevilla Spain
Oncomed S.R.L. Timisoara Romania
Pratia S.A. Skorzewo Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Muenchen Klinik gGmbH Munich Germany
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Cardiomed S.R.L. Cluj Napoca Romania
Hospital Alvaro Cunqueiro Vigo Spain
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Spitalul Municipal Onesti Sf. Ierarh Luca Onesti Romania
Howkisio Ufszculrvdqye Dz Blgcgxy Badajoz Spain
Wqbghhtjerz Wexauesivvrqrwtftgjg Cqbplry Ovfvgqurn I Tiezybfedhakv Ir Mbanqecvhpi W Lqqro Lodz Poland
Mzd fnie Haqssvwkbnbw ufo Owtlnybpi Rjaipadkbbf Gcsl Neuss Germany
Khwzgfqqez Cshujue Osxsoqhck Katowice Poland
Aotlrze Uod Ttiitcl ndzp ooyea Leghorn Italy
Mnx Bpgzma Lullcl Babyzjjwg Bonn Germany
Phnqucwqaxi Lvrvchff &apdamqeasjhmjriqixh Rvwzb Kgxrffjehit Konin Poland
Ifrknjbd Rwualxktq Pby Li Sqomhb Dnv Tmmhyg Dshx Ahjebhv Iifg Swxaxa Meldola Italy
Nnwodvsk Itgwvumg Ojgthzris Ifq Mozsl Spzejgdlfipxkigdnnxidcemntnb Iheixjbk Bfikgryg Cracow Poland
Uthsgkfjwecoyi Cgsnitu Kchydvewg Gdansk Poland
Cpbpxp Hwiaitwfaln Rccizukj Dkkwgzkzngtbdw Angers France
Hhewoahq Vrcs driqcqdv Barcelona Spain
Wcorszhfwp Sciouwo Ias Sxcmfsg Pyh W Ppruszajb Przemysl Poland
Igtxkzoo Cptzt Paris France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
08.12.2025
Germany Germany
Recruiting
08.12.2025
Italy Italy
Not yet recruiting
08.12.2025
Poland Poland
Recruiting
08.12.2025
Romania Romania
Recruiting
08.12.2025
Spain Spain
Recruiting
08.12.2025
The Netherlands The Netherlands
Not yet recruiting
08.12.2025

Trial locations

BNT327 is an investigational medication being tested in this clinical trial. It is given together with chemotherapy drugs to treat extensive-stage small-cell lung cancer in patients who have not received treatment before. This medication is being studied to see if it can help patients live longer when combined with standard chemotherapy.

Etoposide is a chemotherapy medication used to treat various types of cancer, including lung cancer. It works by stopping cancer cells from growing and dividing. In this trial, it is given as part of the standard chemotherapy treatment along with another chemotherapy drug.

Carboplatin is a chemotherapy medication that helps destroy cancer cells. It is commonly used to treat lung cancer and other types of cancer. In this study, it is used together with etoposide as the chemotherapy portion of the treatment.

Atezolizumab is an approved cancer medication that helps the body’s immune system fight cancer cells. It is given together with chemotherapy drugs and is being used as the comparison treatment in this trial to see how it compares to the investigational medication BNT327.

Extensive-Stage Small-Cell Lung Cancer – This is an advanced form of small-cell lung cancer, which is a type of cancer that begins in the lungs and grows rapidly. In the extensive stage, the cancer has spread beyond one lung to the other lung, to lymph nodes on the other side of the chest, or to distant parts of the body. Small-cell lung cancer develops from cells in the airways and tends to grow and multiply quickly. The cancer cells are small in size when viewed under a microscope, which is how this type gets its name. As the disease progresses, it can affect breathing and other body functions as it spreads to different organs. This form of lung cancer is often associated with smoking and typically affects the bronchi, which are the main air passages in the lungs.

Trial ID:
2024-515765-34-00
Protocol code:
BNT327-03
NCT ID:
NCT06712355
Trial Phase:
Therapeutic confirmatory (Phase III)

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