Stolberg

Researchers are evaluating the clinical and health-related outcomes of amivantamab-containing treatment regimens for patients with common EGFR-mutated advanced non-small cell lung cancer NSCLC, including metastatic cases where the cancer has spread. This study observes these treatments in a real-world setting, focusing on patients with specific EGFR mutations exon 19 deletions or exon 21 L858R substitution. It aims to describe how these regimens perform outside of controlled clinical trials. Participants are grouped into two cohorts one receiving amivantamab combined with carboplatin and pemetrexed after prior therapy failure, and another receiving amivantamab with lazertinib as first-line therapy. Treatments are given according to usual clinical practice, and no study drugs are provided. Data collection captures information from routine care, including treatment administration and related medications. During the study, researchers collect data on treatment duration, progression-free survival, overall survival, adverse events, dose changes, concomitant medication use, and quality of life measures using validated questionnaires. Monitoring continues for up to approximately 60 months. Participants provide informed consent, and all data comes from standard medical records without additional interventions or procedures required by the study.

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are conducting a large real-world observational study called LIVER-R to gather data on patients with hepatobiliary cancers, specifically unresectable hepatocellular carcinoma uHCC and advanced biliary tract cancers aBTC. The study aims to evaluate the outcomes of patients treated with durvalumab-based regimens, including combinations like STRIDE and durvalumab plus chemotherapy, as part of routine clinical practice or early access programs. This study is descriptive and noncomparative, focusing on real-world effectiveness and clinical characteristics across multiple countries and centers. The study will collect both primary data during patients routine visits and secondary data from medical records at enrollment and every 6 months. It includes a baseline period of up to 5 years before starting durvalumab treatment and a follow-up period lasting up to 3 years for uHCC patients and 2 years for aBTC patients. Data collected will cover treatment patterns, clinically significant events, concomitant medications, and various real-world clinical outcomes such as survival rates, progression-free survival, time to treatment progression, and recurrence-free survival. Participants will be adults diagnosed with hepatobiliary cancer and treated with durvalumab-based regimens as decided by their physicians. Researchers will monitor overall survival and other outcomes at multiple time points over the follow-up period. Data collection involves routine clinical visits, medical record review, and tracking of treatment and event timelines. The study will provide insights into the real-world use and outcomes of durvalumab therapies for these cancers, with continuous monitoring until death, withdrawal, loss to follow-up, or study completion.