By participating in drug, medical device, non-interventional studies, clinical registries, and investigator-initiated studies, we significantly advance research in thoracic surgery, pulmonology, and oncology. Our goal is to expand current knowledge and to test and evaluate new forms of therapy under controlled conditions.
Types of Studies
Fundamentally, a distinction must be made between retrospective and prospective studies. Retrospective investigations involve the analysis of existing data, such as retrieving data from existing patient records or measurements on collected tumor samples.
Prospective investigations, on the other hand, plan the collection of specific data in the future and evaluate it after the completion of the study period. This is the case, for example, when all tumor samples from the following year are examined for the presence of a characteristic, and the subsequent fate of these patients is then tracked.
A special form of prospective studies are so-called interventional studies, which aim to determine the effectiveness of a medical intervention (e.g., a new drug). In these studies, only a portion of the patients receives the new drug, while the others receive standard therapy. By observing the further course of the disease in all patients, it is then possible to determine whether the new drug is better (or worse) than the previous standard. To ensure a good and fair comparison, it must be ensured that other influencing factors (e.g., age, disease stage, motivation) are evenly distributed in both groups. This is best achieved through “randomization,” meaning the random assignment of each patient to one of the two groups.
All studies that collect patient identity (so-called “personal data”) require the prior and informed consent of the patient, who can withdraw it at any time. This applies particularly to interventional studies, where the type of therapy is determined by the study. This occasionally leads to uncertainty among patients or third parties (“guinea pigs”) due to the suspicion of misuse. Sufficient clarification and thus transparency can counteract this. It is important in this context that these studies may only be conducted with the consent of the fully informed patient, and that they also require review and approval by an independent ethics committee. Data is only forwarded to the study center in anonymized form. Patient insurance is routinely taken out.
The concern that patients receiving standard therapy would be treated worse must be countered by the fact that comparisons are only ethically justifiable if one does not know which therapy is better. Furthermore, one would not undertake the effort of a study if it were already known that the new therapy is superior to the old one.
Oncological Studies
Lung Carcinoma
- CRISP Observational Study
Observation of molecular biomarker testing, treatment, and therapy outcomes in patients with non-small cell lung carcinoma - FINN Observational Study
Observational study on therapy with Nivolumab + Ipilimumab with 2 cycles of chemotherapy in non-small cell lung carcinoma
Pleural Mesothelioma
- Pleural Tumor Registry
Registry for the evaluation/standardization of established, but especially new, therapeutic concepts for malignant pleural mesothelioma
Thoracic Oncological Studies
Observational Studies:
- Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients (CRISP) Study
- Prospective non-interventional study (NIS) to examine the effectiveness of Tremelimumab + Durvalumab + platinum chemotherapy (TDC) in patients with metastatic non-squamous NSCLC and high-risk genetic alterations
Application Observational Studies:
- TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (TIGER Meso)-Study
Interventional Studies
- A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 Expression ≥ 1%
- Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)
- Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)
- Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer – SUNRAY-02
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