Misterbianco

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor CDK46i and letrozole compared to placebo plus CDK46i and letrozole in adults with endocrine-sensitive PIK3CA-mutated hormone receptor-positive HR, HER2-negative advanced breast cancer. This phase III, randomized, double-blind study focuses on participants who have measurable disease and meet specific hormone receptor and HER2 status criteria. Participants are randomly assigned to receive either oral inavolisib once daily along with letrozole and CDK46i or placebo once daily with letrozole and CDK46i. The CDK46i is given on a schedule of either Days 1-21 or Days 1-28 of each 28-day cycle. The study includes parallel groups to compare these treatment combinations over time. During the study, participants will be monitored for progression-free survival, overall survival, response rates, duration of response, clinical benefit, and changes in pain, physical function, and global health status. Safety will be assessed by tracking adverse events and patient-reported treatment side effects using questionnaires. The study will follow participants for up to seven years, with regular evaluations to track disease status and quality of life.

Researchers are evaluating the effects of the drug imlunestrant LY3484356 in premenopausal women with early estrogen receptor-positive ER, HER2-negative breast cancer. The study includes two groups one that explores imlunestrant alone or combined with ovarian suppression, and another that studies imlunestrant without ovarian suppression. The trial compares imlunestrants impact on breast cancer cells and ovarian function to tamoxifen, a known treatment. Participants in Cohort 1 will receive imlunestrant orally either alone or with goserelin a drug given by injection to suppress ovarian function for up to 29 days. Some in this group will take tamoxifen orally as a comparator. Cohort 2 participants will take imlunestrant or tamoxifen orally for up to 6 months without ovarian suppression. The study is open-label, randomized, and phase 2, designed to assess treatment effects in parallel groups. During the study, participants will provide tumor samples before and during treatment, and researchers will monitor changes in specific cancer markers like Ki-67, estrogen receptor ER, and progesterone receptor PR expression. They will also track the rate of ovarian cysts up to 180 days. Participants must attend scheduled visits for evaluations, including performance status checks and safety assessments. The trial is expected to continue until December 2029.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer NSCLC who do not achieve a complete response after initial therapy. This Phase 3 trial compares the combination of sacituzumab tirumotecan plus pembrolizumab against pembrolizumab alone, focusing on disease-free survival assessed by a blinded independent central review. The study is sponsored by Merck Sharp & Dohme LLC and targets participants with specific stages of NSCLC who have undergone neoadjuvant therapy and surgery but still have residual disease. Participants first receive neoadjuvant therapy consisting of pembrolizumab combined with double-platinum chemotherapy tailored to the tumor type for up to 12 weeks before surgery. After surgery, those not achieving pathological complete response are assigned to either receive sacituzumab tirumotecan infusions every two weeks for up to 24 weeks alongside pembrolizumab monotherapy every six weeks for approximately 42 weeks, or pembrolizumab monotherapy alone on the same schedule. Rescue medications to manage infusion reactions may be given as needed during the study. Throughout the trial, participants undergo assessments including radiological scans, tumor tissue analysis for markers like PD-L1 and TROP2, and monitoring for adverse events and quality of life changes. Key outcomes include disease-free survival, overall survival, distant metastasis-free survival, and lung cancer-specific survival, with evaluations continuing for up to nearly 10 years. Safety and tolerability are closely monitored, and questionnaires assess physical functioning, symptoms like cough and chest pain, and overall health status during and after treatment.

Researchers are evaluating the safety, tolerability, and effectiveness of combining Imzokitug with Pumitamig and Platinum-Doublet Chemotherapy PDCT compared to Pumitamig and PDCT alone. The study focuses on adults with locally advanced or metastatic non-small cell lung cancer NSCLC who have not received previous systemic therapy for advanced or metastatic disease. This is a Phase 2 interventional trial assessing first-line treatments for this condition. Participants will receive either the combination of Imzokitug, Pumitamig, and PDCT or Pumitamig with PDCT alone. Treatment involves specified doses given on certain days, with tumor tissue samples required for analysis. The study is randomized and parallel in design, with multiple experimental arms. The primary treatment period extends up to approximately four years, during which the response to therapy will be closely monitored. Throughout the trial, participants will undergo evaluations including tumor assessments using RECIST v1.1 criteria to measure objective response rates. Safety will be monitored by documenting adverse events, serious adverse events, and treatment-related effects up to 90 days after the last treatment. Researchers will also track progression-free survival, overall survival, duration of response, and time to recurrence during the study and follow-up periods. The trial is sponsored by Bristol-Myers Squibb and aims to collect comprehensive data over several years.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.