„Any research study of a medical product involving human subjects conducted for the purpose of discovering or verifying the clinical, pharmacological or pharmacodynamic effects of that product. The purpose of a clinical research may also be to identify adverse effects of an investigated product or to assess its absorption, distribution, metabolism and excretion, in order to verify the safety and/or efficacy of the product used.”
source: ICH GCP (International Conference on Harmonisation Good Clinical Practice Guidelines), version 9 November 2016
Specjalistyczny Szpital Onkologiczny w Tomaszowie Mazowieckim (The Specialized Oncological Hospital NU-MED in Tomaszów Mazowiecki) participates in conducting clinical trials. This is an opportunity to save the lives and health of patients for whom previous therapy has not led to a cure or has not significantly improved the patient's health. Clinical trials are conducted with new or previously used drugs. The evaluation of new treatment concepts and innovative drugs in oncology during clinical trials enables the rational decision-making process for introducing new, effective cancer treatments to the market.
Clinical trial protocols are designed to ensure the safety and clinical benefit of the participants. This is overseen by bioethical committees and relevant government institutions. The therapeutic benefits of participating in clinical trials must outweigh the potential risks for the patient.
Participation in clinical trials is voluntary. Patients make this decision independently after thoroughly understanding all potential benefits and risks associated with the therapy. They have the opportunity to discuss various issues related to participation in the trial with a physician. Before joining a clinical trial, patients are required to familiarize themselves with the information contained in the "Informed Consent for Participation in a Clinical Trial" form and sign the document.
Patients participating in clinical trials can still access healthcare services funded by the National Health Fund (NFZ) as indicated for their health condition.
Participation in a clinical trial is entirely free of charge. Patients can withdraw their consent to participate in the trial at any time.
THREE PHASES OF CLINICAL TRIALS
The introduction of new oncological drugs or therapeutic methods occurs in stages, and there are three phases in conducting clinical trials. A positive outcome in each phase is necessary to move on to the next phase. Each phase must end positively for a drug to be approved for general use.
Phase I: In cases where the study concerns a new drug for a rare or incurable disease (e.g., malignant tumors), volunteers may include individuals suffering from this disease. The study group typically consists of several dozen people. The primary goal of Phase I is to preliminarily assess the safety of the tested substance. During this phase, researchers evaluate absorption, metabolism, excretion, toxicity, interactions with food, and commonly used medications.
Phase II: A larger group of participants, typically patients diagnosed with the specific disease, is involved in this phase. Phase II is considerably longer than Phase I, sometimes lasting several years. During this phase, the effectiveness of the tested drug in patients with the disease is confirmed. An analysis is conducted to determine the balance between the benefits of using the treatment and the risks of using the experimental product. If the benefits significantly outweigh the risks, Phase III trials are initiated.
Phase III: This phase is conducted on a much larger scale than the previous two phases, with up to 1,000 or more participants, including patients diagnosed with the specific disease. Phase III usually lasts from 3 to 5 years and aims to:
In this phase of clinical trials, the effectiveness and safety of using the new drug in combination with other standard therapies are also evaluated.
If the results of the third phase of clinical trials are positive, indicating that the tested drug provides the potential for better treatment compared to currently available therapeutic approaches, efforts can be made to obtain its registration and subsequently introduce it to the market.
Research code: HLX10-020-SCLC302
Research name: A randomized, international, multicenter, double-blind double-blind study to evaluate the anticancer efficacy and safety of HLX10.
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD
Research population: Patients With Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Research drug: HLX10 (recombined humanized anti-PD-1 monoclonal antibody for insertion) or placebo in combination with chemotherapy (carboplatin/cisplatin-etoposide) and concomitant radiotherapy.
Research code: CAMBRIA2 (D8535C00001)
Research name: A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Kamizestrant (AZD9833, a Novel Generation Oral, Selective Estrogen Receptor Degrading Factor) Compared to Standard Hormone Therapy (Aromatase Inhibitor or Tamoxifen)
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD
Research population: Adjuvenant therapy in patients with ER+ (dadatnim)/HER2- (negative) early-stage breast cancer with an intermediate high or high risk of recurrence who have completed drug-regional therapy and are symptomatic of the disease.
Research drug: Vest (AZD9833)
Research code: D926PC00001
Research name: Open-label, randomized Phase 3 trial evaluating datopotamab deruxtecan (Dato-DXd) versus investigator's choice chemotherapy in patients not candidates for PD-1/PD-L1 inhibitor therapy in first-line treatment of locally recurrent, unresectable or metastatic triple-negative cancer breasts (TROPION Breast02).
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD
Research population: patients with triple-negative breast cancer after recurrence
Research drug: datopotamab deruxtecan
Research code: D9078C00001
Research name: Randomized, double-blind, placebo-controlled, multicenter, international Phase III study evaluating durvalumab in combination with oleclumab and durvalumab with monalizumab in patients with locally advanced (stage III), unresectable non-small cell lung cancer ( NSCLC) who did not progress after radical, platinum-based, simultaneous chemoradiotherapy (PACIFIC-9)
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with small cell lung cancer, for concurrent chemotherapy-radiotherapy
Research drug: durvalumab
Research code: PM1183-C-008-21-Lagoon
Research name: Randomized, multicenter, open-label Phase III study of lurbinectin monotherapy or lurbinectin in combination with irinotecan compared with investigator's choice (topotecan or irinotecan) in patients with recurrent small cell lung cancer (SCLC)
Indication: Lung cancer Principal Investigator
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: Patients with recurrent small-cell lung cancer (SCLC)
Investigational Drug: Topotecan or irinotecan
RECRUITMENT COMPLETED
Research code: EXELIXIS_XL092-303
Research name: Randomised, open-label, phase III research evaluating the use of XL092 in combination with atezolizumab versus regorafenib in patients with metastatic colorectal cancer
Indication: colorectal cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with metastatic colorectal cancer after treatment with oxalipaltin and irinotecan and not treated with lonsurf - i.e. after the second and before the third line of treatment.
Investigated drug: XL092 with atezolizumab
Research code: D967Y00001
Research name: Phase Ib multicentre open-label, dose-escalation research evaluating the safety and tolerability of trastuzumab derukstecan (T-DXd) and durvalumab in combination with cisplatin, carboplatin or pemetrexed in the first-line treatment of patients with advanced or disseminated non-squamous non-small cell lung cancer and human epidermal growth factor receptor type 2 (HER2+) overexpression (DESTINY-Lung03).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: lung cancer patients, HER2 positive
Investigated drug: enhertu ( + immunotherapy)
Research code: D9268C00001
Research name: Open randomised phase III research evaluating Dato-DXd (datopotamab derukstekan) compared with investigator-selected chemotherapy in patients with inoperable or disseminated breast cancer without HER2 receptor overexpression and with estrogen and/or progesterone receptors who have previously received systemic treatment with one or two lines of chemotherapy (TROPION-Breast01).
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with luminal B-cell carcinoma
Investigated drug: datopotamab deruxtecan
RECRUITMENT COMPLETED
Research code: D8534C00001
Research name: Randomised, double-blind, Phase III research evaluating a change of treatment to the AZD9833 regimen (next-generation oral SERD) in combination with a CDK4/6 inhibitor (palbocyclizib or abemacyclizib) compared with continued treatment with an aromatase inhibitor (letrozole or anastrozole) in combination with a CDK4/6 inhibitor in patients with advanced hormone receptor-positive (HR+) breast cancer without HER2 overexpression (HER2- ) with detectable estrogen receptor gene mutation (ESR1), with no disease progression during first-line treatment with an aromatase inhibitor regimen in combination with a CDK4/6 inhibitor - a research with early treatment change dependent on ctDNA diagnosis (Serena)
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients treated for breast cancer with palbocyclib or abemacyclib in combination with an aromatase inhibitor, after one year of therapy with improvement
Research drug: new generation hormone therapy (SERD) in combination with CDK4/6 inhibitors
Research code: HABER
Research name: The study is non-interventional in nature and involves the collection of data from patients with hormone receptor-positive, HER 2 negative advanced breast cancer admitted to the centre between 1 September 2020 and 31 August 2021 for first-line treatment of advanced breast cancer as part of their standard medical care. The research is a retrospective analysis of medical records.
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: NIVEAU
Research name: Optimising the outcome of elderly and ineligible patients on high-dose chemotherapy for aggressive non-Hodgkin's lymphoma at first relapse or progression by adding nivolumab to gemcitabine, oxaliplatin and rituxumab for B-NIVEAU-derived lymphoma, DSHNHL 2015-1.
Indication: lymphoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: MS062202-0083_STARTER
Research name: Prospective non-interventional study to evaluate the response to first-line treatment of metastatic colorectal cancer with Cetuximab in combination with FOLFIRI according to tumour location in patients with wild-type RAS/BRAF mutations, with lesions periodically introduced by the Sponsor.
Indication: colorectal cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: CASSIOPE
Research name: Prospective, non-interventional study with cabozantinib tablets for the treatment of advanced renal cell carcinoma (RCC) in adult patients with prior vascular endothelial growth factor (VEGF)-targeted therapy.
Indication: renal cell carcinoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: AFLIBL08831|
Research name: Prospective observational study to evaluate the efficacy and safety of aflibercept used together with FOLFIRI chemotherapy in patients with metastatic colorectal cancer according to the treatment standard and reimbursement rules of aflibercept in Polish centres in the period 2018-2020.
Indication: large bowel
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: BV MAZOVIA
Research name: Observational study. Efficacy and safety of brentuximab vedotin (BV) consolidation treatment of patients with Hodgkin’s lymphoma (HL) undergoing autologous haematopoietic cell transplantation (ASCT). A prospective, multicentre observational research.
Indication: lymphoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with Hodgkin’s lymphoma (HL) undergoing autologous haematopoietic cell transplantation (ASCT)
Investigated drug: OBSERVATION RESEARCH
Research code: D933YC00001
Research name: A randomized, double-blind, placebo-controlled, multicenter phase III study of durvalumab consolidation therapy in patients with locally advanced unresectable non-small cell lung cancer (stage III) who did not progress after definitive, platinum-based chemotherapy (PACYFIC 5).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: BA3021-001
Research name: Phase I/II clinical trial with dose escalation and dose expansion stage with enrollment of additional patients for the selected dose of ozuriftamab vedotin (BA3021) as monotherapy and in combination with nivolumab in the treatment of patients with advanced solid tumors.
Indication: melanoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: BA3011-002
Research name: hase II clinical trial of mecbotamab vedotin (BA3011) as monotherapy and in combination with nivolumab in the treatment of adult patients with metastatic non-small cell lung cancer who have previously progressed on treatment with PD-1/L1, EGFR or ALK inhibitors or who have intolerance to these inhibitors occurs.
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD
Research code: DESTINY GASTRIC 03
Research name: Phase 1b/2, multicenter, open-label, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of trastuzumab deruxtecan (T-DXd) as monotherapy or in combination in adult participants with gastric cancer expressing HER2 (DESTINY-Gastric03)
Indication: gastric cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Study population: In monotherapy or in combination therapy in adult participants with HER2-expressing gastric cancer (DESTINY-Gastric03)
Investigated drug: Trastuzumab deruxtecan
Research code: D933IC00001
Research name: An open-label, multicentre phase 1b study evaluating the efficacy and safety of durvalumab in combination with new oncology therapies, with or without chemotherapy in the first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC) (MAGELLAN).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: EFC15935
Research name: Randomised, multicentre, double-blind phase 3 research evaluating combination treatment: SAR439859 and palbociclib compared with letrozole and palbociclib in patients with ER(+) and HER2(-) breast cancer not previously treated for advanced disease.
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D910MC00001
Research name: Randomised, multicentre, double-blind, placebo-controlled phase III research evaluating durvalumab in the treatment of patients with stage II and III non-small-cell lung cancer with minimal residual disease after surgery and therapy with intention to treat (MeRmaiD-2).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D910LC00001
Research name: Multicentre double-blind, placebo-controlled phase III research evaluating the efficacy of adjuvant therapy with durvalumab in combination with platinum derivative-based chemotherapy for the treatment of patients with stage II and III non-small cell lung cancer after complete resection (MeRmaiD-1).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D933QC00001
Research name: Randomised, double-blind, placebo-controlled, multicentre, international phase III research evaluating the use of durvalumab or durvalumab in combination with tremelimumab as consolidation treatment in patients with limited small cell lung cancer who have not progressed after concurrent chemoradiotherapy (ADRIATIC).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: GSK3359609
Research name: Randomised double-blind phase II/III adaptive research evaluating GSK3359609 or placebo in combination with pembrolizumab for first-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck with PD-L1 expression.
Indication: head and neck cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: CL3-95005-006-POL
Research name: Open, randomised phase III research comparing the use of trifluridine/tipiracil (s 95005) with bevacizumab to capecitabine with bevacizumab in the first-line treatment of patients with metastatic colorectal cancer who are ineligible for intensive treatment (SOLSTICE research).
Indication: colorectal cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D3614C00001
Research name: Phase III, double-blind, randomised research evaluating the efficacy of capivasertib with paclitaxel compared to placebo with paclitaxel as first-line treatment for patients with histologically confirmed locally advanced (inoperable) or metastatic triple-negative breast cancer (CAPITELLO-290?).
Indication: breast cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: BNT111-01
Research name: Randomised, open-label, phase II research with BNT111 and cemiplimab in combination or monotherapy in patients with refractory anti-PD-1 antibody treatment/relapsed, inoperable stage III or IV melanoma.
Indication: melanoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with stage III or IV melanoma who have experienced treatment failure after immunotherapy
Investigated drug: BNT111 mRNA vaccine in combination with cemiplimab acting on PD-L1 and PD-L2 receptors (combination of 2 different mechanisms affecting the immune system, increasing the immune response)
Research code: CACZ885U2301
Research name: Randomised, double-blind, placebo-controlled phase III research evaluating the efficacy and safety of pembrolizumab in combination with platinum derivative-based two-drug chemotherapy, with or without canakinumab, for the first-line treatment of patients with locally advanced or metastatic non-squamous and squamous non-small cell lung cancer (CANOPY-1).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: CT-P16 3.1
Research name: Randomised double-blind, parallel-group, active-controlled phase 3 research to compare the efficacy and safety of CT-P16 and the EU-approved drug Avastin as first-line treatment of metastatic or recurrent non-squamous non-small cell lung cancer.
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D933YC00001
Research name: Randomised double-blind, placebo-controlled, multicentre phase III research evaluating durvalumab in consolidation therapy in patients with locally advanced inoperable non-small cell lung cancer (stage III) who have failed to progress after definitive platinum derivative-based chemotherapy (PACYFIC 5).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: ACT16903
Research name: Phase 2 non-randomised, open-label, multicentre study evaluating the clinical benefit of SAR444245 (THOR-707) in combination with other anticancer drugs in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).
Indication: head and neck cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with head and neck cancer - failure of previous therapies
Research drug: PD-1 immunotherapy + research drug from the immunomodulatory group
Research code: INCB50465-205
Research name: Open-label, multicentre phase II research conducted in two cohorts evaluating INCB050465, a PI3Kδ inhibitor, in the treatment of relapsed mantle cell lymphoma or refractory mantle cell lymphoma previously treated or untreated with a BTK inhibitor (CITADEL-205).
Indication: lymphoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: D4194R00026 -DESCARTHES
Research name: Non-interventional, observational multicentre research to collect routine clinical practice data on the management of patients with inoperable stage III non-small cell lung cancer (NDRP) undergoing radical radiotherapy in Poland (DESCARTHES research).
Indication: lung cancer
Principal researcher: Michał Spych, MD,PhD
Research population: patients with inoperable non-small cell lung cancer (NSCLC) at clinical stage III, after radical radiotherapy
Research drug: OBSERVATION RESEARCH
Research code: D419MC00004
Research name: Randomised, multicentre, open-label, comparative, global phase III research evaluating the efficacy of durvalumab and tremelimumab in combination with platinum derivative-based chemotherapy administered as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC).
Indication: lung cancer
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: WO30070
Research name: Randomised, multicentre, placebo-controlled phase III research evaluating the effect of Atezolizumab (ANTY-PD-L1 antibody) in monotherapy and in combination with platinum compound-based chemotherapy in previously untreated patients with locally advanced or metastatic urothelial carcinoma.
Indication: bladder
Principal researcher: Ewa Chmielowska, MD, PhD
Research code: INCMOR 0208-301
Research name: A multicentre, phase 3, randomised, double-blind, placebo-controlled research evaluating the efficacy and safety of tafasitamab plus lenalidomide in addition to rituximab compared with lenalidomide in addition to rituximab in patients with relapsed and refractory (R/R) grade 1-3a nodular lymphoma or R/R marginal zone lymphoma .
Indication: lymphoma
Principal researcher: Ewa Chmielowska, MD, PhD
Research population: patients with refractory nodular and marginal zone lymphoma
Research drug: tafasitamab + lenalidomide