Boulogne Billancourt

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

Researchers are evaluating the safety, effectiveness, and how the body processes zipalertinib in adults with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has specific mutations in the Epidermal Growth Factor Receptor (EGFR) gene, including exon 20 insertions and other uncommon mutations. This Phase 2b study also explores potential drug interactions of zipalertinib with certain enzyme and transporter substrates and aims to find the best dosing plan for the medication. Participants will be enrolled into one of four main groups based on their specific EGFR mutation status and treatment history. These groups include those previously treated with exon 20 insertion agents, those untreated and unsuitable for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Additionally, separate substudies will assess drug interactions using enzyme and transporter probe cocktails and will test different doses of zipalertinib in randomized groups until treatment discontinuation. Throughout the study, participants will undergo regular assessments including imaging scans, neurological exams, and laboratory tests to monitor disease progression and treatment safety. Researchers will track response rates over up to two years and evaluate brain metastasis stability when applicable. Safety monitoring, including cardiac function and adverse effects, will be ongoing. The study requires tissue samples to confirm mutation status and participants will be followed closely to evaluate the medication's impact and tolerability.

Researchers are evaluating the effects of different antibiotic infusion strategies in patients hospitalized in intensive care units with hospital-acquired sepsis caused by multidrug-resistant Gram-negative bacteria. This Phase 4 trial uses a 2x2 factorial design to compare continuous versus intermittent infusion of pivotal beta-lactam antibiotics and combination therapy with aminoglycosides versus monotherapy. The main goal is to assess 30-day mortality and major adverse kidney events in these patients. Participants are randomly assigned to one of four treatment groups: continuous infusion of beta-lactam antibiotics combined with a 5-day aminoglycoside infusion, intermittent infusion of beta-lactam antibiotics with a 5-day aminoglycoside infusion, continuous infusion of beta-lactam antibiotics with at most one dose of aminoglycoside, or intermittent infusion of beta-lactam antibiotics with at most one dose of aminoglycoside. Randomization also accounts for the type of beta-lactam administered. Treatments are delivered according to these infusion schedules during the ICU stay. During the study, patients will be monitored for vital outcomes including survival at 30 days after sepsis diagnosis and kidney function events such as the need for renal replacement therapy or persistent kidney dysfunction. Researchers will collect relevant clinical data and bacteriological samples before starting treatment. The study focuses on patients expected to stay in the ICU for more than three days and will observe their progress closely during the 30-day period following sepsis onset.

This trial investigates the effect of bougie diameter size on the risk of staple-line leaks following laparoscopic sleeve gastrectomy (LSG), a common weight-loss surgery for people with morbid obesity. Staple-line leaks occur in about 3% of cases and can lead to serious complications and long recovery. The study compares the use of a standard bougie size (34, 36, or 38 French) versus a larger 48-Fr bougie to see if a bigger diameter reduces leak rates without affecting weight loss outcomes. Participants undergo LSG where a bougie is inserted through the mouth by the anesthesiologist to calibrate the size of the stomach remnant. The surgery is done alongside the bougie, with patients unaware of which bougie size is used. The study is randomized and prospective, focusing on comparing postoperative outcomes related to gastric leak and mid-term weight loss between the two bougie sizes. During the study, researchers monitor patients for 30 days after surgery to measure the rate of gastric leaks. Participants are followed to evaluate mid-term weight loss results. The study includes regular assessments and safety checks to track complications. This research aims to identify if using a larger bougie can lower leak risks while maintaining effective weight loss after LSG.

This research investigates treatment options for patients with intermittent claudication due to long lesions (15-25 cm) in the superficial femoral artery, a condition affecting many active individuals over 60 years old. It addresses the lack of dedicated clinical trials comparing femoro-popliteal bypass surgery to endovascular procedures, the latter currently recommended as first-line despite limited evidence on their long-term success. Participants receive either femoro-popliteal bypass surgery using the best vascular substitute available, such as an inverted saphenous vein or vascular prosthesis, under general or local anesthesia, or an endovascular procedure performed under general, local anesthesia, or sedation involving balloon angioplasty followed by stent placement or drug-coated balloon angioplasty. Both treatments target restoring blood flow through the affected artery. Throughout the study, researchers monitor the primary outcome of artery patency at two years post-procedure. Participants undergo assessments to track treatment success and safety, with careful attention to eligibility, informed consent, and follow-up over this period. The study aims to clarify which approach better maintains artery openness in patients with symptomatic lower limb artery disease.