Howrah

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

Researchers are studying treatments for non-small cell lung cancer NSCLC in patients who have an EGFR mutation and whose disease has progressed after EGFR tyrosine kinase inhibitor TKI therapy. This trial compares the investigational drug Izalontamab Brengitecan BMS-986507 with platinum-based chemotherapy combinations including carboplatin or cisplatin plus pemetrexed. The study is a randomized phase 23 trial designed to evaluate these treatments in this specific group of lung cancer patients. Participants will receive one of several study treatments Izalontamab Brengitecan given at specified doses on scheduled days, or platinum-based chemotherapy with either carboplatin or cisplatin combined with pemetrexed. The trial includes multiple experimental and active comparator arms to assess the therapies effects following prior EGFR TKI treatment failure. Treatment schedules and doses are specified for each drug as part of the trial interventions. During the trial, participants will be monitored for several outcomes including progression-free survival assessed by established criteria over up to three years, as well as overall survival up to five years. Other measures include objective response, disease control rate, duration and time to response. Safety and organ function will also be evaluated. The study involves regular assessments and follow-up visits to collect these data over the course of the trial.

Researchers are evaluating the safety and effectiveness of trastuzumab deruxtecan T-DXd Enhertu4 combined with pembrolizumab compared to platinum-based chemotherapy combined with pembrolizumab for people with locally advanced unresectable or metastatic non-squamous non-small cell lung cancer NSCLC that overexpresses HER2 and has PD-L1 tumor proportion score less than 50%. Participants must not have received prior therapy for this condition and should not have known actionable genomic alterations with locally available treatments. Participants are randomly assigned to one of two treatment groups. One group receives T-DXd intravenously at 5.4 mgkg every three weeks plus pembrolizumab 200 mg IV every three weeks. The other group receives pemetrexed 500 mgm2 IV plus a platinum chemotherapy agent cisplatin 75 mgm2 or carboplatin AUC 5 mgmLmin IV every three weeks along with pembrolizumab 200 mg IV every three weeks. Treatments continue as first-line therapy for advanced or metastatic disease. During the study, participants will have tumor tissue samples assessed for HER2 and PD-L1 expression. Researchers will monitor progression-free survival by imaging review up to about 54 months and overall survival up to about 85 months. The trial is open-label and randomized, with assessments including safety monitoring and efficacy evaluations. Participants are followed throughout treatment and for a long-term period to measure outcomes related to disease progression and survival.