Reddipatti

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 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.

Researchers are evaluating whether olomorasib combined with pembrolizumab or durvalumab is more effective than these immunotherapies alone in participants with KRAS G12C-mutant non-small cell lung cancer NSCLC. The study focuses on two groups those with resected NSCLC and those with unresectable NSCLC. This Phase 3 trial aims to assess disease-free survival and progression-free survival among these participants over an estimated period of up to 3 years. Participants will receive either olomorasib or a placebo orally along with pembrolizumab or durvalumab administered intravenously for up to one year. After this combination phase, participants continue with olomorasib or placebo alone for up to a total of three years of treatment. The study includes randomized, double-blind groups to compare these combinations in both resected and unresectable NSCLC. During the study, participants undergo regular assessments to monitor disease progression, overall survival, and quality of life using questionnaires and imaging. Researchers measure outcomes such as disease-free survival, progression-free survival, response rates, and symptom changes related to NSCLC. The study also tracks safety and health impacts over the treatment period, which may last up to three years for each participant.