Trials Catalog

First-Line-Therapy (Metastatic Disease/Hematology)

Pierre Fabre F60089IV101 VERT-002

Title: A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06669117
Description: The trial NCT06669117 is a first-in-human, open-label Phase I/II study of VERT-002 (PFL-002), an intravenous c-MET degrader, in adults with locally advanced or metastatic solid tumors harboring documented MET gene alterations (e.g., MET ex14 skip, activating MET kinase-domain mutations, or MET amplification). The primary objective is to evaluate safety, tolerability and to determine the maximum tolerated dose (MTD) and/or optimal biologically active dose (OBD). Eligible adults have tumors for which no standard therapy is available, or NSCLC Stage IIIB/C or IV, with measurable disease per RECIST 1.1 and ECOG performance status 0–1. MET alteration status is confirmed at screening via local or central testing. Participants receive VERT-002 in a sequential dose-escalation followed by expansion cohort. Key secondary endpoints include pharmacokinetics, objective response rate and safety profile.

Krascendo 2

Title: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT06793215
Description: The purpose of this study is to evaluate the efficacy and safety of divarasib andpembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin,for the first-line treatment of adult participants with KRAS G12C-mutated, advanced ormetastatic non squamous non-small cell lung cancer (NSCLC).

eVOLVE-Lung02

Title: A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT05984277
EudraCT-number: 2023-000056-38
Description: The eVOLVE-Lung02 trial is a global, randomized, open-label Phase?III study comparing volrustomig (MEDI5752) plus platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy in adults with first-line metastatic non-small cell lung cancer (NSCLC) lacking EGFR, ALK or ROS1 driver alterations. The primary objective is to evaluate efficacy (e.g., progression-free survival) and safety of the novel synergy of volrustomig and chemotherapy. Eligible participants are adults with histologically or cytologically confirmed stage?IV NSCLC, no sensitizing EGFR mutation or ALK/ROS1 rearrangement, and who are treatment-naïve for systemic therapy. Molecular driver status is confirmed as negative at screening. Participants are randomised 1:1 between the two treatment arms. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), overall survival (OS) and safety/tolerability profiles.

DESTINY-Lung04 (AstraZeneca)

Title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05048797
EudraCT-number: 2021-000634-33
Description: DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

BI 1479-0008 Beamion LUNG-2

Title: Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Prof. Dr. med. Gunnar Folprecht
Registration: NCT06151574
Description: This study is open to adults 18 years and older with advanced or metastatic non-smallcell lung cancer. People can join the study if they have tumours with HER2 mutations andhave not yet received any systemic therapy including chemotherapy for advanced ormetastatic lung cancer. The purpose of this study is to find out whether a medicinecalled zongertinib (BI 1810631) can slow down the worsening of advanced non-small celllung cancer better than the standard treatment available. Zongertinib may slow cancercell growth by inhibiting HER2. This would prolong cancer re-occurrence and increasesurvival. Current standard treatment is pembrolizumab plus platinum-pemetrexedchemotherapy.Participants are put into 2 groups by chance. One group receives zongertinib at regulartimes throughout the study and the other group receives infusions of pembrolizumab,pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexedchemotherapy) into a vein.Participants may be in the study up to a

FLAURARE_AIO-TRK-0324

Title: Osimertinib plus chemotherapy as 1st line therapy in stage IV NSCLC patients with atypical EGFR mutations (AIO-TRK/YMO-0324)
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
EudraCT-number: 2024-516790-78
Description: The clinical trial FLAURARE is an international, multicenter, open-label Phase II study evaluating the combination of Osimertinib plus platinum-based chemotherapy (carboplatin or cisplatin plus pemetrexed) as first-line therapy in patients with stage IV non–small cell lung cancer (NSCLC) harboring uncommon EGFR mutations. The primary objective is to assess the efficacy of the combination treatment. Key inclusion criteria include histologically or cytologically confirmed metastatic adenocarcinoma NSCLC, untreated metastatic disease, presence of one or more EGFR mutations in exons 18–21 excluding common mutations (exon 19 deletion, L858R, exon 20 insertion, T790M), confirmed EGFR status, ECOG performance status = 1, at least one measurable lesion per RECIST v1.1, and adequate organ function. All participants receive Osimertinib plus chemotherapy in a single-arm design. Secondary endpoints include safety, tolerability, and patient-reported quality of life.

ANTELOPE

Title: Atezolizumab/Carboplatin/Nab-Paclitaxel vs. Pembrolizumab/Platinum/Pemetrexed in Metastatic TTF-1 Negative Lung Adenocarcinoma
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT05689671
Description: This is an open-label randomized, controlled, multicenter, phase II trial with two arms. Patients with metastatic TTF-1 negative, treatment-naive lung adenocarcinoma without actionable genomic alterations are randomized in a 1:1 manner to investigate the efficiency of atezolizumab, carboplatin and nab-paclitaxel (Arm A) versus pembrolizumab, cis-/carboplatin and pemetrexed (Arm B) as first-line treatment.

AMG20240178_DeLLphi-312

Title: A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT07005128
Description: DeLLphi-312 (NCT07005128) is a multicenter, randomized, open-label phase III trial comparing the bispecific T-cell engager tarlatamab plus durvalumab, carboplatin, and etoposide versus the standard regimen of durvalumab with carboplatin and etoposide in first-line treatment of previously untreated, extensive-stage small-cell lung cancer (ES-SCLC). The primary objective is to assess whether the addition of tarlatamab improves overall survival (OS). Eligible participants are adults (= 18 years) with histologically or cytologically confirmed ES-SCLC (AJCC 2017 Stage IV, or T3–T4 with extensive pulmonary tumor/nodal burden), measurable disease per RECIST 1.1, and suitability to receive the carboplatin/etoposide plus durvalumab first-line regimen. Participants are randomized to receive either tarlatamab + durvalumab + carboplatin + etoposide (for four cycles, followed by tarlatamab and durvalumab) or the comparator arm durvalumab + carboplatin + etoposide (four cycles, followed by durvalumab). Key secondary endpoints include safety/tolerability and additional efficacy measures.

Second line + Treatment (Metastatic Disease)

Biontech BNT 326-02

Title: A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC) A clinical trial to test if an investigational combination therapy with BNT326 and BNT327 is safe and potentially beneficial for people with advanced non-small cell lung cancer (NSCLC)
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
EudraCT-number: 2024-519344-32
Description: BNT326-01 is a Phase Ib/II, multi-site, open-label, dose-finding trial evaluating the safety, efficacy, and pharmacokinetics of BNT326 (anti-Her3 mAb) in combination with BNT327 (anti-VEGF-A antibody fused with an anti-PD-L1 antibody). The study enrolls adult participants diagnosed with advanced non-small cell lung cancer (NSCLC). The primary objectives are to assess the safety profile and to determine the recommended dose for the combination therapy. Secondary endpoints include the evaluation of objective response rates and the pharmacokinetic properties of both investigational agents. As an open-label trial, all eligible participants receive the experimental combination treatment. This study provides critical data on the clinical activity and tolerability of dual targeting in advanced stages of NSCLC.

IOV-LUN-202

Title: A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT04614103
EudraCT-number: 2020-003629-45
Description: The Phase II IOV-LUN-202 trial is an open-label, multicenter, non-randomised cohort study evaluating the autologous tumor-infiltrating lymphocyte therapy LN-145 in adults with metastatic non-small-cell lung cancer (NSCLC) lacking EGFR, ALK or ROS1 driver mutations. The primary objective is to assess the objective response rate (ORR) per RECIST 1.1. Eligible patients are adults with documented radiographic progression following at least one line of systemic therapy including an immune checkpoint inhibitor plus platinum-based chemotherapy. Screening excludes the presence of EGFR, ALK and ROS1 driver mutations. Treatment is delivered in sequence: a non-myeloablative lymphodepleting preparative regimen followed by LN-145 infusion and IL-2 administration in non-randomised cohorts. Key secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the safety profile.

MK2870-004

Title: A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT06074588
Description: The MK-2870-004 trial is a randomized, open-label Phase III study comparing sacituzumab tirumotecan (MK-2870), a TROP2-directed antibody-drug conjugate (ADC), with standard chemotherapy (docetaxel or pemetrexed) in adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring an EGFR mutation (exon 19 del or exon 21 L858R) or other genomic alterations (e.g., ALK rearrangements, ROS1 rearrangements, BRAF V600E, NTRK fusions, MET exon14 skipping, RET rearrangements or rare EGFR point mutations). The primary objectives are progression-free survival (PFS) per RECIST 1.1 assessed by blinded independent central review (BICR) and overall survival (OS). Inclusion criteria include documented radiographic progression, prior lines of EGFR TKI (for EGFR mutant cohort) and platinum-based therapy, measurable disease per RECIST 1.1, and ECOG performance status 0–1. Participants are randomized to either MK-2870 or chemotherapy. Key secondary endpoints include objective response rate (ORR) and duration of response (DOR).

RMC-Lung-101:

Title: A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06162221
Description: The trial NCT06162221 is an open-label, multicenter Phase?1/2 platform interventional study evaluating novel RAS(ON) inhibitors in adults with advanced or metastatic non-small cell lung cancer (NSCLC) harbouring documented RAS gene mutations (e.g., KRAS, NRAS, HRAS). The primary objective is to establish recommended Phase?2 dose (RP2D) and assess objective response rate (ORR) across multiple sub-protocols. Eligible participants have ECOG performance status 0–1, adequate organ function, confirmed RAS-mutation and non-curatively treatable advanced or metastatic disease. Molecular RAS-mutation status is confirmed at screening. Patients are enrolled non-randomised in parallel cohorts (e.g., RMC-6291 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 ± RMC-6236 + pembrolizumab ± chemotherapy; RMC-9805 monotherapy). Key secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety/tolerability profiles.

RMC-6236-301_ RASolve 301

Title: RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT06881784
Description: RASolve 301 (NCT06881784) is a multicenter, randomized, open-label Phase III trial comparing the oral pan-RAS(ON) inhibitor daraxonrasib (RMC-6236) versus intravenous docetaxel in adult patients with advanced, RAS-mutant non-small cell lung cancer (NSCLC) that is locally advanced or metastatic. medsearchglobal.com The primary objectives are to evaluate progression-free survival (PFS) and overall survival (OS) in the RAS-mutant population (notably RAS G12X, excluding G12C). Eligible patients must have histologically or cytologically confirmed NSCLC, measurable disease per RECIST v1.1, ECOG performance status 0–1, adequate organ function, documented RAS mutation (KRAS, NRAS, or HRAS codon 12, 13 or 61), and prior therapy with 1–2 lines including platinum-based chemotherapy and immune checkpoint inhibition. Patients are randomized 1:1 to receive either daraxonrasib orally or docetaxel intravenously. Key secondary endpoints include safety and tolerability, objective response rate (ORR), and PFS/OS in the overall RAS-mutant cohort.

Amgen 20230153

Title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC).
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06593522
EudraCT-number: 2024-514459-14
Description: The Phase II MTAPESTRY 201 trial evaluates the investigational agent AMG 193 in adults with histologically or cytologically confirmed, metastatic or unresectable locally advanced non-small cell lung cancer (NSCLC) harboring a homozygous deletion of the MTAP gene. The primary objective is to characterize the safety, tolerability, pharmacokinetics and efficacy of two dose levels of AMG 193 via investigator assessment and a Blinded Independent Central Review (BICR). Key inclusion criteria include prior systemic therapy, availability of archived tumor tissue, life expectancy greater than three months, and treated or stable brain metastases = 2 cm without need for corticosteroids. The molecular status (MTAP homozygous deletion) is confirmed during screening; patients with actionable driver mutations (EGFR, ALK, ROS1, NTRK, MET, BRAF, RET, HER2, KRAS G12C) are excluded. Treatment is administered orally once daily in 28-day cycles in a sequential dose-escalation and expansion design. Important secondary endpoints include safety profiles, PK parameters and preliminary response rates.

AbbVie M18-868

Title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Phase: phase III
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT04928846
Description: TeliMET NSCLC-01 (NCT04928846) is a global, multicenter, randomized, open-label Phase III trial comparing the antibody–drug conjugate Telisotuzumab Vedotin (ABBV-399) versus Docetaxel in adults with previously treated, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met and is EGFR wild-type. The co-primary endpoints are overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review. Eligible subjects must have histologically or cytologically confirmed non-squamous NSCLC, c-Met overexpression (= 25 % tumor cells at 3+ intensity by IHC, SP44 assay), EGFR wild-type status, ECOG performance status = 1, and prior systemic therapy. Participants are randomized 1:1 to receive either Telisotuzumab Vedotin intravenously every 2 weeks or Docetaxel every 3 weeks. Key secondary endpoints include objective response rate (ORR), duration of response, health-related quality of life, and safety/tolerability.

REZILIENT2

Title: An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Dr. med. Felix Saalfeld
Registration: NCT05967689
Description: The purpose of this study is to evaluate the safety and efficacy of zipalertinib inpatients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations andother mutations.

Lilly J5J-OX-JZZA

Title: A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06586515
EudraCT-number: 2024-516440-25
Description: Trial J5J-OX-JZZA is a Phase 1a/1b study evaluating the compound LY3962673 in participants with advanced solid tumors harboring a KRAS G12D mutation. The primary objective is to assess the safety, tolerability, and antitumor activity of LY3962673 administered as monotherapy or in combination with other cytotoxic agents. The study enrolls adult patients with advanced or metastatic solid tumor types. Molecular eligibility regarding the KRAS G12D status is confirmed during the screening period. Participants are assigned to receive the study drug either as a single agent or in combination regimens. Key endpoints include dose-limiting toxicities, objective response rates, and the pharmacokinetic profile of the intervention.

Radiotherapy Studies

Pacellio

Title: PACCELIO - FDG-PET based small volume accelerated immuno chemoradiotherapy in locally advanced NSCLC
Phase: phase II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4582238
Contact E-Mail-Address: str.studien@uniklinikum-dresden.de
Examiner: Dr. med. Rebecca Bütof
EudraCT-number: 2023-510506-41
Description: Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first. After end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.

PRONTOX

Title: Protonenbehandlung zur primären Radiochemotherapie bei fortgeschrittenen Nicht-kleinzelligen Bronchialkarzinomen zur Verminderung der Normalgewebstoxizität
Legal foundation: Berufsordnung
Contact: +49 351-4582238
Contact E-Mail-Address: str.studien@uniklinikum-dresden.de
Examiner: Prof. Dr. med. Dr. Esther Troost
Registration: NCT02731001

ADRIATIC-p

Title: Real World Validierung des Outcome bei Patientinnen und Patienten mit Kleinzelligem Lungenkarzinom nach kurativ intendierter Radiotherapie im Rahmen multimodaler Konzepte analog dem ADRIATIC Trial (ADRIATIC)
Contact: +49 351-4582238
Contact E-Mail-Address: str.studien@uniklinikum-dresden.de
Examiner: Dr. med. Rebecca Bütof
Description: The aim of this data collection is to investigate the influence of durvalumab maintenance therapy on treatment success in patients with small cell lung cancer after definitive chemoradiotherapy. In particular, the aim is to analyze how the response after definitive chemoradiotherapy was over time without durvalumab as maintenance therapy alone compared to the combination, and which factors (e.g., age, tolerability) influence the course of therapy. The study will combine both prospective and retrospective data collection in order to obtain a comprehensive picture of current treatment practice and a historical perspective on the development of therapeutic approaches. This will enable an informed assessment of the most effective treatment strategies for small cell lung cancer and could provide important insights for future therapeutic decisions.

E2-RADIatE - OligoCare

Title: A pragmatic observational cohort study to evaluate radical radiotherapy for oligo-metastatic cancer patients
Legal foundation: Berufsordnung
Contact: +49 351-4582238
Contact E-Mail-Address: str.studien@uniklinikum-dresden.de
Examiner: Dr. med. Annekatrin Seidlitz
Description: The objective of E²-RADIatE is the collection of real-world data of cancer patients treated with radiotherapy, to support radiotherapy research and to provide evidence of the role of radiation oncology in a multidisciplinary approach. E²-RADIatE is open ended.

other systemic therapies

BMS CA052-002

Title: A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT04895709
EudraCT-number: 2021-001188-26
Description: This first-in-human, phase 1/2 study evaluates BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in adults with advanced solid tumours, with the primary objective of assessing safety, tolerability and determining recommended phase-2 dose(s). Adult patients with advanced or metastatic disease, measurable disease per RECIST v1.1, ECOG performance status 0–1 and documented radiographic progression after most recent therapy are eligible; protocol-defined fresh pre- and on-treatment tumor biopsies are required for biomarker analyses. Subjects are enrolled into dose-escalation and dose-expansion cohorts (part 1A–1C: escalation; part 2A–2B: expansion) receiving BMS-986340 alone or combined with BMS-936558 (nivolumab) or docetaxel as per arm. Secondary assessments include preliminary anti-tumour activity, pharmacokinetic profiling and immunogenicity evaluations.

Pierre Fabre STX-241 (SILVER)

Title: Phase I/II First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants with Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06567015
EudraCT-number: 2023-510203-21
Description: This trial is an international, multicenter, open-label Phase I/II first-in-human study assessing the safety and efficacy of STX-241 in participants with EGFR-mutated NSCLC. The primary objectives are to establish the maximum tolerated dose (MTD) and to evaluate the objective response rate (ORR) per RECIST 1.1. Eligible participants are adults with locally advanced or metastatic non-small cell lung cancer who have demonstrated resistance to prior EGFR tyrosine kinase inhibitor (TKI) therapy. Molecular eligibility is confirmed during screening to identify specific EGFR mutations. Participants are enrolled in dose-escalation and dose-expansion cohorts to receive STX-241. Key secondary endpoints include pharmacokinetics (PK), duration of response (DOR), and progression-free survival (PFS).

Immatics IMA 203-101

Title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)
Phase: phase I
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT03686124
EudraCT-number: 2019-002370-31
Description: IMA203-101 is a multicenter Phase 1 study evaluating autologous T cells engineered to express a specific T-cell receptor (ACTengine® IMA203) in patients with relapsed or refractory solid tumors. Patient eligibility is confirmed through HLA-A*02:01 screening and tumor biomarker analysis. Following leukapheresis and manufacturing of the IMA203 product, patients receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance cell engraftment. The primary objective is to evaluate safety, tolerability, and the recommended Phase 2 dose (RP2D), supported by a 14-day regimen of low-dose subcutaneous IL-2 after infusion. As this is a gene therapy medicinal product (GTMP), long-term follow-up for up to 15 years is required. Key secondary endpoints include objective response rate (ORR) per RECIST 1.1 and the long-term persistence and expansion of the engineered T cells.

IMA402-101 (bispecific T cell engaging receptor molecule)

Title: A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid Tumors.
Phase: phase I/II
Legal foundation: Arzneimittelgesetz
Contact: +49 351-4587566
Contact E-Mail-Address: ectu@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT05958121
EudraCT-number: 2022-503133-54
Description: IMA402-101 is a multicenter, open-label, Phase I dose-escalation study evaluating the bispecific T-cell receptor (TCER®) molecule IMA402 in patients with PRAME-positive solid tumors. The primary objective is to evaluate safety, tolerability, and to determine the recommended Phase II dose (RP2D) based on dose-limiting toxicities (DLTs). Eligible participants include adult patients with recurrent or refractory malignancies, including cutaneous and uveal melanoma as well as non-small cell lung cancer. Enrollment requires confirmation of the HLA-A*02:01 haplotype and documented PRAME expression within the tumor tissue. The investigational product is administered intravenously in ascending dose cohorts. Key secondary endpoints include pharmacokinetics and preliminary anti-tumor activity assessed by RECIST v1.1 criteria.

Scorpion STX-721-101

Title: First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Phase: phase I
Legal foundation: Arzneimittelgesetz
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT06043817
EudraCT-number: 2023-506759-51
Description: STX-721-101 is a multicenter, open-label, Phase 1/2 study evaluating the selective inhibitor STX-721 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations. The primary objective is to characterize the safety and tolerability of STX-721 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Eligible participants are adults with an ECOG performance status of 0-1 who have progressed on or are intolerant to standard-of-care therapies. Molecular eligibility must be confirmed via documented testing (e.g., NGS) during screening. The study follows a dose-escalation design followed by dose-expansion cohorts. Key secondary endpoints include pharmacokinetic parameters and the objective response rate (ORR) according to RECIST 1.1.

Other clinical trials

TIGER Meso study

Title: TTFields in general routine clinical care in patients with pleural mesothelioma study
Legal foundation: Berufsordnung
Contact E-Mail-Address: studienzentrum-vtg@ukdd.de
Examiner: Prof. Dr. med. Till Plönes
Registration: NCT0553880
Description: Pleural mesothelioma is a rare cancer that is commonly associated with asbestos exposure. Due to the aggressiveness of the disease, the prognosis is very poor. Patients can be treated with different combinations of chemotherapy, surgery and radiotherapy as well as immunotherapy. For early stage pleural mesothelioma, various treatment options can be taken into consideration and there is no consensus on the preferred treatment option. Tumor Treating Fields (TTFields) are low-intensity (1-3 V/cm), intermediate frequency (150 KHz for pleural mesothelioma) alternating electric fields that interfere with cell division. TTFields? anti-mitotic mechanism of action is based on disruption of cell spindle-apparatus by interfering with key electrically charged molecules, such as tubulin or septin proteins that are required for the mitotic process. Interference with these key molecules can lead to cell death through multiple pathways. Pre-clinical studies have shown that TTFields are able to effectively inhibit tumor growth, both, in vitro and in vivo without any systemic side effects. In addition, safety of in vivo TTFields application to the torso was confirmed in a more recent study

nNGM

Title: nationales Netzwerk genomische Medizin - Lungenkrebs
Legal foundation: Berufsordnung
Contact: +49 351-4587566
Contact E-Mail-Address: nngminfo@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Description: The National Network Genomic Medicine Lung Cancer (nNGM) centralizes molecular diagnostics for non-small cell lung cancer (NSCLC) throughout Germany for the first time. In this way, a comprehensive genetic analysis of the tumor can be made available to all treatment providers during initial therapy planning. For this purpose, comprehensive molecular diagnostics will be offered in specialized nNGM network centers - subsequent treatment can then take place close to home in an oncology practice or in the local hospital.

PALUGA

Title: Von Patienten-abgeleitete Lungentumor-Organoide in der Präzisionsonkologie
Legal foundation: Berufsordnung
Contact: +49 351-4587666
Contact E-Mail-Address: oncostudy@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Description: A clinical trial to study the applicability of lung cancer organoids for diagnostic, therapeutic and biologic questions.

CRISP

Title: Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (AIO-TRK-0315)
Legal foundation: Berufsordnung
Registration: NCT02622581
Description: Clinical Research platform Into molecular testing, treatment and outcome of non-Small cell lung carcinoma Patients (CRISP)

IMPALUX

Title: Immune-Marker Platform for Patients With Advanced Lung Cancer
Legal foundation: Berufsordnung
Contact: +49 351-45816226
Contact E-Mail-Address: impalux-studie@ukdd.de
Examiner: Prof. Dr. med. habil Martin Wermke
Registration: NCT07150598
Description: IMPALUX is a prospective, observational, multi-center platform study in adult patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) lacking actionable driver mutations (ALK, EGFR, BRAF, HER2, MET, NTRK, RET, ROS1) and with PD-L1 tumor cell expression (TPS < 50%). The study aims to elucidate the association between tumor immune/molecular features and response as well as disease course under standard-of-care immunochemotherapy. Patients provide tumor biopsies at baseline, around six weeks after initiation of immunochemotherapy, and upon suspected disease progression for molecular and immunohistochemical profiling of immune and gene expression markers. No investigational drug is administered; the design is purely observational. Secondary objectives include identifying biomarkers predictive for response and progression-free survival.