Study on Maintenance Treatment with Pembrolizumab and Pemetrexed for Stage IV Non-Small Cell Lung Cancer Patients After Initial Chemotherapy and Immunotherapy

4 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for stage IV Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study is evaluating the effectiveness of a medication called pembrolizumab, which is also known by the brand name Keytruda. Pembrolizumab is a type of immunotherapy, which means it helps the body’s immune system fight cancer. In this trial, pembrolizumab may be used alone or in combination with another medication called pemetrexed, which is a chemotherapy drug. The study will also compare these treatments to a placebo, which is a substance with no active medication, to see how well they work in controlling the disease.

The purpose of the study is to determine how effective pembrolizumab is when used as a maintenance treatment after an initial six months of chemotherapy combined with pembrolizumab. The chemotherapy used in the initial treatment includes drugs like carboplatin, cisplatin, and paclitaxel, which are common medications used to treat various cancers. The study will observe patients to see if continuing pembrolizumab helps in maintaining disease control compared to stopping treatment after the initial phase.

Participants in the study will receive treatment through infusions, which means the medication is given directly into the bloodstream. The study will last for several months, and patients will be monitored regularly to assess their response to the treatment. The goal is to find out if pembrolizumab can help patients live longer and maintain a better quality of life compared to those who do not continue with the treatment after the initial phase. The study will also look at how the treatment affects different subtypes of NSCLC, such as squamous and non-squamous cell carcinoma, and how it relates to specific tumor characteristics like PD-L1 expression, which is a protein that can affect how the immune system responds to cancer.

1 initial treatment phase

Upon joining the study, the initial treatment phase begins. This phase involves a combination of medications administered through an infusion. The medications include pemetrexed, carboplatin, paclitaxel, cisplatin, and pembrolizumab. These medications are given to help control the cancer.

The treatment is administered over a period of six months. During this time, the patient will receive these medications at regular intervals as determined by the study protocol.

2 maintenance phase

After completing the initial six-month treatment phase, the patient enters the maintenance phase. In this phase, the patient may continue to receive pembrolizumab with or without pemetrexed, depending on the type of lung cancer.

The maintenance treatment continues until the cancer progresses or the patient experiences significant side effects. Alternatively, the patient may be placed under observation without receiving further treatment, depending on the study’s randomization process.

3 regular monitoring

Throughout the trial, the patient will undergo regular monitoring. This includes scheduled visits to the clinic for health assessments, laboratory tests, and imaging studies such as CT or MRI scans to evaluate the cancer’s response to treatment.

The monitoring helps ensure the patient’s safety and allows the study team to track the effectiveness of the treatment.

4 end of trial participation

The trial participation concludes when the patient completes the treatment protocol, the cancer progresses, or the patient decides to withdraw from the study.

At the end of the trial, the patient will have a final assessment to evaluate their overall health and the outcomes of the treatment received during the study.

Who Can Join the Study?

Must have signed a written informed consent form, agreeing to participate in the study and follow the study procedures.
Must have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC), which means the cancer has spread to other parts of the body.
Must have a PD-L1 tumor content assessment, which is a test to check for a specific protein in the cancer cells.
Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, indicating the ability to carry out daily activities with little or no assistance.
Must not have lost more than 10% of body weight in the last 3 months.
Must not have received any prior systemic anticancer therapy for advanced or metastatic disease.
Must be between 18 and 74 years old.
Must have a life expectancy of more than 3 months.
Must have measurable tumor disease as determined by a CT or MRI scan, following specific criteria.
Must have adequate tumor tissue available for analysis. This means having enough cancer tissue from a biopsy for testing.
Must have adequate biological functions, including:
- Creatinine Clearance of at least 45 mL/min, which is a measure of kidney function.
- Neutrophils count of at least 1500/mm³, which are a type of white blood cell important for fighting infections.
- Platelets count of at least 100,000/mm³, which are cells that help with blood clotting.
- Hemoglobin level of at least 9g/dL, which is a protein in red blood cells that carries oxygen.
- AST and ALT levels less than 3 times the upper limit of normal, which are liver enzymes.
- Total bilirubin level less than 2 times the upper limit of normal, which is a substance made by the liver.
Women of childbearing potential must use effective contraception starting 28 days before the first dose and continuing for 6 months after the last dose. They must also have a negative pregnancy test before starting the study.
Men who are sexually active with women of childbearing potential must use effective contraception during the study and for 6 months after the last dose.
Must have national health insurance coverage.

Who Cannot Join the Study?

Patients who have a different type of cancer than non-small cell lung cancer.
Patients who have not completed a 6-month induction treatment.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who are pregnant or breastfeeding.
Patients who have another serious medical condition that might interfere with the study.
Patients who are taking medications that might interfere with the study treatment.
Patients who have participated in another clinical trial recently.
Patients who have a known allergy to the study medication.
Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Colmar	Colmar	France
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Institut Godinot	Reims	France
Hopital Europeen Marseille	Marseille	France
Hopital Prive De La Loire	Saint-Etienne	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Hopital Prive Jean Mermoz	Lyon	France
Centre Hospitalier De Cannes Simone Veil	Cannes	France
Clinique de l’Europe	Amiens	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Centre Hospitalier Le Mans	Le Mans	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier De Saint-Quentin	Saint Quentin	France
Grand Hopital De L Est Francilien	Meaux	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier Universitaire de la Réunion – Site Sud	Saint Pierre	France
Clinique Mutualiste de l’Estuaire	St Nazaire	France
Cgkkhn Hpccjtgkwph Uyuzsvqsmyuue Rhwpk	Reims	France
Crolzm Hdgxuqgcuej Dr Ctaeek	Chauny	France
Cummpz Hziqcvpgkcc Eq Uxcbscmccqzxr Dm Limprnr	Limoges	France
Bisrocpa Ubeztlntkc Hixblsht Cvmutn	Besançon	France
Ckjeex Hensuscbjdi Rftroqtm Uztrffuhkkzbf Db Txtgt	Tours	France
Cmkspk Hospulstsmz Rziyhmhb Dndoycrokkzrby	Angers	France
Imsrxwzb dn Cpsfyniwhnab Hdhxcwjedjd Uyimkcudmpygf dl Siooq Eowhpan (abvwyte	Saint Priest En Jarez	France
Hymurgb Rjicul Stupqot	Vantoux	France
Hqpwhqlq Ulqyqfowrturvw Ssrztiosdl &malogw Hxzmxfb dn Hjqthmgcdly	STRASBOURG, Alsace	France
Ieqvnbbk Cxihw	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.05.2022

Trial locations

Investigated drugs:

Pembrolizumab is a type of immunotherapy used in this clinical trial. It works by helping your immune system recognize and attack cancer cells. In this study, pembrolizumab is given to patients with stage IV Non-Small Cell Lung Cancer (NSCLC) who have already received an initial treatment with chemotherapy and pembrolizumab. The goal is to see if continuing pembrolizumab can help control the cancer for a longer period.

Pemetrexed is a chemotherapy drug used in this trial for patients with non-squamous Non-Small Cell Lung Cancer (NSCLC). It works by interfering with the growth of cancer cells, slowing down or stopping their spread. In this study, pemetrexed may be given alongside pembrolizumab or during the observation period to see if it helps maintain control over the cancer after the initial treatment phase.

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can invade nearby tissues and spread to other parts of the body, a process known as metastasis. NSCLC often grows and spreads more slowly than small cell lung cancer, which is another major type of lung cancer. The progression of NSCLC can vary depending on the subtype and other factors, such as genetic mutations and environmental influences. Early stages may not show symptoms, but as it advances, symptoms like persistent cough, chest pain, and difficulty breathing may occur.

Trial ID:

2024-515945-40-00

Protocol code:

IFCT-2103

NCT ID:

NCT05255302

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Maintenance Treatment with Pembrolizumab and Pemetrexed for Stage IV Non-Small Cell Lung Cancer Patients After Initial Chemotherapy and Immunotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?