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A phase I/II, multicenter, open-label study of EGFRmut-TKI EGF816, administered orally in adult patients with EGFRmut solid malignancies (CEGF816X2101)

Phase I partPrimary:* Determine the maximum tolerated dose (MTD) or the recommended phase II dose (RP2D).Secondary:* Safety and tolerability, * ORR, duration of response (DOR), disease control rate (DCR), progression free survival (PFS) and time to…

A clinical imaging Study of the changes in [18F]F-AraG uptake following radiotherapy in Non-small cell lung cancer.

This study has been transitioned to CTIS with ID 2024-517960-45-00 check the CTIS register for the current data. • To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon anti-PD-1 treatment• To assess the relationships between…

Dual-immunotherapy and short-course medium-dose radiotherapy, followed by surgery for tumor microenvironment modification in early-stage NSCLC

This study has been transitioned to CTIS with ID 2024-516580-87-00 check the CTIS register for the current data. • to assess the pathologic response to durva and RT • to assess the safety of combining durva and RT

Preparation of AKT-DC from Lymph nodes derived through Surgery and Endobronchial ultrasound guided biopsy in non-small cell lung cancer patients.

To assess whether procedures and techniques used to derive AKT-DC out of lymph node material influences the quality and number of the AKT-DC end-product.

Injection of 99mTc-nanocolloid and ICG to identify, retrieve and qualify tumor draining lymph nodes in early-stage lungcancer

The primary objective is to determine the feasibility of identifying the TDLN in patients with NSCLC (cT1 to cT2b) on SPECT/CT imaging and during surgical resection using a radioactive and fluorescent tracer, 99mTc-nanocolloïd and ICG respectively.…

A Multicenter, Phase 1/1b Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects with Advanced Solid Tumors

The purpose of this study is to evaluate how safe telisotuzumab vedotin is and how telisotuzumab vedotin is tolerated as monotherapy and in combination with osimertinib.

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…

A clinical imaging study using [18F]F-AraG PET to visualize Tumor infiltrating T-cell Activation in Non-small cell lung cancer

• To perform full kinetic modeling of [18F]F-AraG for the uptake in tumor lesions and healthy organs (e.g. spleen) by exploring different kinetic models and outcome measures as well as its test-retest (TRT) variability to guide the selection of an…

Response and Toxicity Prediction by Microbiome analysis in locally advanced NSCLC treated with IO (durvalumab) after Chemoradiotherapy (sequential and concurrent)

The predictive value of the microbiome (throat swabs and stool samples) to identify patients who will relapse during durvalumab treatment after CRT (False negative Rate) at 6 months. Exploratory endpoints include the effects of antibiotic therapy…

A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination with Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+)
(DESTINY-Lung03) (D967YC00001)

- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed

Neoadjuvant nivolumab combination treatment in resectable non-small cell lung cancer patients: Defining optimal combinations and determinants of immunological response

This study has been transitioned to CTIS with ID 2024-513074-22-00 check the CTIS register for the current data. Primary Objective:The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with…

Immune profiling of stage III non-small cell lung cancer patients treated with concurrent chemoradiation and adjuvant durvalumab: A prospective observational phase II trial

Primary Objective: To identify immune changes between baseline, one week of radiotherapy, end of radiotherapy and three months of durvalumab- Identification of differentially expressed proteins at all time points- Identification of differentially…

A Phase II, two arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study)

The main objective of this study is to assess the efficacy of tepotinib combined with osimertinib inparticipants with advanced or metastatic EGFRm+ NSCLC and MET amplification, determined centrally by FISH.The secondary objectives are the following:…

Combining Afatinib and concurrent chemotherapy, followed by Osimertinib and concurrent chemotherapy, in untreated EGFR positive NSCLC tumors

• to assess the efficacy of the sequential combination strategy of front-line afatinib-chemo, followed by a treatment with osimertinib-chemo in those patients that develop a T790M mutation as a mechanism of resistance.

A MULTICENTER, OPEN-LABEL PHASE 1 STUDY OF HE3-DXd IN SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER

This study has been transitioned to CTIS with ID 2024-511205-33-00 check the CTIS register for the current data. Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and…

A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in
Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

This study has been transitioned to CTIS with ID 2024-516598-60-00 check the CTIS register for the current data. Primary Objective: To compare Overall Survival (OS) in patients with non-squamous NSCLC who have experienced disease progression on or…

An exploratory study of durvalumab (MEDI4736) uptake during concurrent chemoradiotherapy in stage III NSCLC patients using 89Zr-labeled durvalumab PET

Primary Objectives:* To study early (1 week after start of cCRT) and late changes (after finishing cCRT) in durvalumab (MEDI4736) uptake in tumor and metastatic lymph nodes during cCRT * To study early and late changes in durvalumab (MEDI4736)…

PRospective tumor sampling in oncology patients with solid tumors treated with Immune Modulating Agents

To set up a biobank of prospectively collected tumor samples for genetic and immunological analysis, prior to and during IMA treatment.

An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC)

This study has been transitioned to CTIS with ID 2024-517429-24-00 check the CTIS register for the current data. Objectives:Primary:- Assess safety and tolerability of PDC*lung01 vaccinations administered at two dose levels as single agent or during…

ELDAPT: Elderly with locally advanced Lung cancer: Deciding through geriatric Assessment on the oPtimal Treatment strategy

Developing a clinically applicable geriatric screening instrument to stratify medically fit patients who may benefit from intensified treatment strategies and frail patients who will undergo best supportive care (which may include palliative RT), (2…