Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as limited-stage small cell lung cancer (LS-SCLC). This is a form of cancer that affects the lungs and is typically treated with a combination of chemotherapy and radiation therapy. The study is investigating the use of two medications, Toripalimab and Tifcemalimab, as potential treatments for patients who have not experienced disease progression after receiving standard treatments.

The purpose of the study is to evaluate the effectiveness of these medications when used as a follow-up treatment, also known as consolidation therapy, to help prevent the cancer from returning or worsening. Participants in the study will receive either Toripalimab alone, a combination of Toripalimab and Tifcemalimab, or a placebo. The study is designed to compare the outcomes of these different treatment approaches.

During the study, participants will receive the medications through an intravenous (IV) infusion, which means the medicine is given directly into a vein. The study will monitor participants over a period of time to assess their overall survival and how long they remain free from cancer progression. The trial aims to provide valuable information on whether these treatments can improve outcomes for patients with LS-SCLC.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide informed consent, agreeing to participate and comply with study requirements.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of limited-stage small cell lung cancer and ensuring no disease progression after previous treatments.

3 treatment allocation

The patient will be randomly assigned to one of the treatment groups. This could involve receiving either toripalimab alone, toripalimab combined with tifcemalimab, or a placebo. The treatment is administered intravenously.

4 treatment administration

The patient will receive the assigned treatment intravenously. The frequency and duration of administration will be determined by the study protocol and communicated to the patient.

5 regular monitoring

Throughout the study, the patient will undergo regular monitoring to assess health status and treatment effects. This includes physical exams, blood tests, and imaging studies.

6 follow-up assessments

The patient will participate in follow-up assessments to evaluate the treatment’s impact on overall survival and disease progression. These assessments will be conducted by a blinded independent review committee.

7 completion of study

Upon completing the study, the patient will have a final assessment to gather data on the treatment’s long-term effects. The patient will be informed about the study’s findings and any further steps if necessary.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
If you are a woman who can have children or a man with a partner who can have children, you must use a reliable form of birth control, like a birth control pill or condom, during the study and for at least 4 months after the last dose of the study medication.
You must agree to participate in the study, sign a consent form, and follow all study procedures.
You must have a confirmed diagnosis of limited-stage small cell lung cancer (LS-SCLC) that can be treated with radiation. If you have Stage I or II disease, you must not be able to have surgery or choose not to have it.
You must have completed a specific type of treatment called chemoradiotherapy (CRT), which includes 4 cycles of chemotherapy with drugs like carboplatin or cisplatin and etoposide, and a certain amount of radiation. You must start the study treatment within 42 days after finishing this treatment.
You must have shown a complete response, partial response, or stable disease after the CRT and must not have any disease progression before joining the study.
Prophylactic cranial irradiation (PCI), a type of radiation to the brain to prevent cancer spread, is allowed if your doctor thinks it’s necessary. It can be done before or during the study.
You need to provide about 5 slides of tumor tissue for analysis. If you can’t provide these samples, you may still join the study after discussing with the study team.
You must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, which means you are fully active or have some symptoms but can still do light work.
You must have a life expectancy of at least 12 weeks.
Your organs must be functioning well, which includes having enough blood cells, normal liver and kidney function, and normal blood clotting ability.

Who Cannot Join the Study?

Patients who have not completed chemoradiotherapy (CRT). This is a treatment that combines chemotherapy and radiation therapy.
Patients whose disease has progressed after receiving CRT. This means the cancer has gotten worse or spread.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medications.
Patients who have a history of other cancers, unless they have been in remission for a certain period.
Patients who have certain infections or diseases that could affect their immune system.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Medisprof S.R.L.	Cluj Napoca	Romania
Centre Hospitalier Intercommunal Creteil	Creteil	France
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centre Hospitalier Universitaire Rouen	Rouen	France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Algemeen Ziekenhuis Klina	Brasschaat	Belgium
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
San Camillo Forlanini Hospital	Rome	Italy
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Grand Hopital De Charleroi	Charleroi	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Oncolab S.R.L.	Craiova	Romania
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Centre De Cancerologue Du Grand Montpellier	Montpellier	France
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Hospital Quironsalud Malaga	Malaga	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Jessa Ziekenhuis	Hasselt	Belgium
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Spitalul Clinic Colentina – Pediatric Dermatology	Bucharest	Romania
Cwbmou Lrri Bhjqfl	Lyon	France
Icegqw Icvzsyct Flvxtvlnlzavv Oopfnggwacf	Rome	Italy
Rvjanfugc Zbfzkpijir Saolmjvqi	Arnhem	The Netherlands
Ngqbiprm Iiszmympk Oa Tygnjtwxlwkf Agd Lvuf Davpxsyc	Warsaw	Poland
Iovsvmvr Roynqoccg Pmm Lu Saotgd Djy Tixmvo Devj Axlvjhp Iefg Svxgrx	Meldola	Italy
Eebxbqq Uwcrfgsaybls Mmzrodd Cagkems Rqgarebze (jopzvnn Myf	Rotterdam	The Netherlands
Cenymo Hdorekkzdnr Rvqacnli Uteaehlpsphzh Dd Tpzfj	Tours	France
Hkleaxna Uunsrhysclpfl Dbseidie	Donostia / San Sebastian	Spain
Clqenu Htpudolzwiw Rvffuifc Dxqtevfipdltfk	Angers	France
Fzazuokec Pdkd Ls Ilsrdbdqoavht Bagfleoth Dpo Hikmrfjz Uzzqpnhdnlxpx Lj Plq	Madrid	Spain
Hkdxtflt Vsfe dmqadhnu	Barcelona	Spain
Hsvsisrr Udlvlofonhyhu db A Ceujyx	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	29.01.2025
France	Not yet recruiting	29.01.2025
Germany	Not yet recruiting	29.01.2025
Italy	Not recruiting	29.01.2025
Poland	Recruiting	29.01.2025
Romania	Not recruiting	29.01.2025
Spain	Recruiting	29.01.2025
The Netherlands	Recruiting	29.01.2025

Trial locations

Investigated drugs:

Toripalimab is a medication used in this clinical trial as a consolidation therapy for patients with limited-stage small cell lung cancer. It is being tested to see if it can help improve survival rates and delay the progression of the disease after patients have received chemoradiotherapy.

Tifcemalimab (JS004/TAB004) is another medication involved in the trial. It is being combined with toripalimab to evaluate if the combination can provide better outcomes for patients with limited-stage small cell lung cancer. The study aims to determine if this combination can enhance overall survival and progression-free survival compared to other treatments.

Limited-stage small cell lung cancer (LS-SCLC) – This is a type of lung cancer characterized by the presence of small, round cancer cells that grow rapidly. It is termed “limited-stage” when the cancer is confined to one side of the chest and can be treated with a single radiation field. The disease often begins in the bronchi, which are the main airways of the lungs, and can quickly spread to nearby lymph nodes. LS-SCLC is known for its aggressive nature and rapid progression, often leading to symptoms such as coughing, chest pain, and difficulty breathing. The disease is typically diagnosed through imaging tests and biopsies, which reveal the small, oval-shaped cancer cells. As the disease progresses, it may spread to other parts of the body, including the brain, liver, and bones.

Trial ID:

2023-507097-41-01

Protocol code:

JS004-008-III-SCLC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?