Studienliste: Lungenkrebs [C34]

Diagnosen

Lungenkarzinom [C34], Kleinzelliges Bronchialkarzinom (SCLC) [C34]

Einschlusskriterien

Kontaktpersonen

felix.john@uk-koeln.de

Ausschlusskriterien

Diagnosen

Lungenkarzinom [C34], Kleinzelliges Bronchialkarzinom (SCLC) [C34]

Einschlusskriterien

Kontaktpersonen

felix.john@uk-koeln.de

Ausschlusskriterien

Diagnosen

Kopf-Hals-Karzinom [C00-C14, C32], Speiseröhrenkrebs (Ösophaguskarzinom) [C15], Magenkarzinom [C16], Bauchspeicheldrüsenkrebs (Pankreaskarzinom) [C25], Lungenkarzinom [C34]

Einschlusskriterien

• 6 Wochen post Krebs-Diagnose
• Onkologische Erkrankung mit Diagnose von (Stadien 1-4):
  • Pankreas Ca,
  • Bronchial Ca,
  • HNS Ca,
  • Oesophagus Ca,
  • Magen Ca oder

• Metastasiert oder nicht-metastasiert
• Keine Kachexie oder Kachexie bei 5%-Gewichtsverlust in den letzten 6 Monaten
• Neo-adjuvante oder adjuvante Systemtherapie (Chemo- oder Immuntherapie) und/oder Strahlentherapie

Kontaktpersonen

freerk.baumann@uk-koeln.de
timo.niels@uk-koeln.de

Ausschlusskriterien

• alleinige OP
• alleinige Bestrahlung

Diagnosen

Lungenkarzinom [C34]

Einschlusskriterien

Ausschlusskriterien

Diagnosen

Lungenkarzinom [C34]

Einschlusskriterien

Ausschlusskriterien

Diagnosen

Kopf-Hals-Karzinom [C00-C14, C32], Solide Tumoren [C00-C75], Lungenkarzinom [C34], Eierstockkrebs (Ovarialkarzinom) [C56]

Einschlusskriterien

• Pathologically confirmed advanced and/or metastatic solid tumor
• Patients may enter screening procedure before, during, or after the last available indicated standard of care treatment. There is no limitation for prior anti cancer treatments.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• HLA phenotype positive
• Measurable disease and accessible to biopsy
• Adequate pulmonary function per protocol
• Acceptable organ and bone marrow function per protocol
• Acceptable coagulation status per protocol
• Adequate hepatic function per protocol
• Serum creatinine within normal range for age OR creatinine clearance with a recommended estimated glomerular filtration rate ≥ 50 mL/min/1.73 m2
• Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
• Life expectancy more than 3 months
• Confirmed availability of production capacities for IMA203 product
• Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.

Ausschlusskriterien

• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Solid tumors with low likelihood of tumor biomarker expression per protocol
• Pregnant or breastfeeding
• Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
• History of cardiac conditions as per protocol
• Prior stem cell transplantation or solid organ transplantation

Diagnosen

Lungenkarzinom [C34], Malignes Melanom [C43], Weichteilsarkom [C49], Gynäkologisches Sarkom [C54], Eierstockkrebs (Ovarialkarzinom) [C56]

Einschlusskriterien

Patients ≥ 18 years old Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication Patients must have received or not be eligible for all available indicated standard-of-care treatments Measurable disease according to RECIST 1.1 Confirmed HLA status ECOG Performance Status of 0 to 1 Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

Ausschlusskriterien

Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed) The patient is pregnant or is breastfeeding History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures Patients with active brain metastases

Diagnosen

Lungenkarzinom [C34]

Einschlusskriterien

AUSWAHL: Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. Participants must have a life expectancy of at least 3 months at the time of randomization.

Ausschlusskriterien

AUSWAHL: Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. Participants must not have untreated central nervous system (CNS) metastases. Participants must not have leptomeningeal metastases (carcinomatous meningitis). Participants must not have concurrent malignancy requiring treatment. Participants must not have an active autoimmune disease. Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management. Participants must not have a history of myocarditis. Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.

Diagnosen

Lungenkarzinom [C34]

Einschlusskriterien

Kontaktpersonen

sebastian.michels@uk-koeln.de

Ausschlusskriterien

Diagnosen

Darmkrebs (Kolorektale Karzinome) [C18-C20], Lungenkarzinom [C34], Malignes Melanom [C43], Hämatoonkologische Erkrankungen [C81-C96]

Einschlusskriterien

Patient 

• vor höchstens 12 Monaten mit Lungenkrebs, Darmkrebs, hämatologische Neoplasie oder malignem Melanom im Frühstadium oder fortgeschrittenen Stadium diagnostiziert worden sein
• in medizinischen Onkologieabteilungen der teilnehmenden Krankenhäuser behandelt
• schriftliche Einverständniserklärung abgegeben
• ECOG-Leistungsstatus 0-2.

Unterstützende Personen

• vom Patienten als jemand benannt, der ihm durch Unterstützung, Ermutigung und Kommunikation bei der Bewältigung seiner Krebserkrankung hilft
• mindestens 18 Jahre alt
• schriftliche Einverständniserklärung abgegeben.
• Ärzte, die in den teilnehmenden Krankenhäusern arbeiten, sind zur Teilnahme an der Studie berechtigt.
  *Da PRISMA methodisch fundierte Gesundheitsdienstleistungsforschung innerhalb einer breiten Patientenprobe nutzt, werden Veränderungen in [...] nicht bewertet. Es ist jedoch geplant, solche Endpunkte als Ergebnisse in eine nachfolgende Studie aufzunehmen, nachdem die Intervention an weitere Untergruppen von Patienten angepasst wurde, die von verstärkten Anstrengungen in den Bereichen Überwachung und Therapietreue profitieren würden.

Kontaktpersonen

michael.mendes-wefelnberg@uk-koeln.de

Ausschlusskriterien

• Unfähigkeit, eine informierte Einwilligung zu erteilen, Interviews und/oder Umfragen selbstständig durchzuführen (Sprache, Wachsamkeit).

Diagnosen

Solide Tumoren [C00-C75], Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Phase 1: Histologisch oder zytologisch bestätigte lokal fortgeschrittene oder metastasierte
solider Tumor mit einem dokumentierten ALK-Rearrangement oder einer aktivierenden ALK-Mutation

Phase 2 Kohorten 2a, 2b und 2c: Histologisch oder zytologisch bestätigter lokal fortgeschrittener
fortgeschrittener oder metastasierter NSCLC mit nachgewiesenem ALK-Rearrangement

Phase-2-Kohorte 2d: Jeder andere histologisch oder zytologisch bestätigte lokal
fortgeschrittenen oder metastasierten soliden Tumor mit einem dokumentierten ALK-Rearrangement oder aktivierende ALK-Mutation, die mit einem zertifizierten Test  nachgewiesen wurde, einschließlich unter anderem anaplastische großzellige Lymphome, entzündliche myofibroblastische diffuse großzellige B-Zell-Lymphome, Plattenepithelkarzinome der Speiseröhre, medulläres Nierenkarzinom, Nierenzellkarzinom, Brustkrebs, kolorektales Karzinom, Eierstockkrebs, papilläres Schilddrüsenkarzinom, Cholangiokarzinom, spitzoide Tumore,
Neuroblastom, anaplastischem Schilddrüsenkrebs und Patienten mit NSCLC, die nicht für die Kohorten 2a-c in Frage kommen.

Kontaktpersonen

claudia.woempner@uk-koeln.de

Ausschlusskriterien

Der Krebs des Patienten weist eine andere bekannte onkogene Treiberveränderung als ALK auf. Die Prüfärzte sollten die Aufnahme in die Studie mit dem Sponsor in Bezug auf Ko-Mutationen besprechen

a. TKI oder andere nicht-chemotherapeutische/nicht-immuntherapeutische Krebsmittel <5 Halbwertszeiten oder <7 Tage, je nachdem, was länger ist.
b. Chemotherapie <21 Tage
c. Immuntherapie oder zelluläre Therapie <28 Tage

Diagnosen

Solide Tumoren [C00-C75], Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Der Teilnehmer muss an einem histologisch oder zytologisch bestätigten, lokal fortgeschrittenen oder
metastasierter NSCLC, der zum Zeitpunkt der Diagnose der lokal fortgeschrittenen oder metastasierten Erkrankung charakterisiert ist.
Weitere kohortenspezifische Krankheitsvoraussetzungen sind:
Kohorten 1 und 3: EGFR Exon19del oder L858R-Mutation
Kohorte 2: EGFR Exon 20ins-Mutation Kohorte 4: Vortherapie mit Amivantamab i.v.

Kontaktpersonen

sebastian.michels@uk-koeln.de
sarah.oerder@uk-koeln.de

Ausschlusskriterien

1. Der Teilnehmer hat eine unkontrollierte Krankheit, einschließlich, aber nicht beschränkt auf:
a. Unkontrollierte Diabetes
b. Laufende oder aktive Infektion (einschließlich Infektionen, die eine Behandlung mit antimikrobielle Therapie

c. Aktive Blutungsdiathee
d. Refraktäre Übelkeit und Erbrechen, chronische gastrointestinale Erkrankungen, Unfähigkeit das formulierte Produkt zu schlucken, oder eine vorangegangene erhebliche Darmresektion, die eine angemessene Absorption der Studienbehandlung ausschließen würden
e. Psychiatrische Erkrankungen oder andere Umstände (einschließlich sozialer Umstände) die die Einhaltung der Studienanforderungen einschränken würden
f. Jeder ophthalmologische Zustand, der klinisch instabil ist

2. Instabile und nicht therapierte Hirnmetastasen

3. (...) 

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34], Eierstockkrebs (Ovarialkarzinom) [C56]

Einschlusskriterien

Kontaktpersonen

juergen.wolf@uk-koeln.de

Ausschlusskriterien

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Ausschlusskriterien

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

•  histologisch bestätigtes NSCLC im inoperablen Stadium III oder metastasierten Stadium IV und eine messbare Erkrankung nach RECIST v1.1 aufweisen.
• in den verschiedenen Kohorten werden unterschiedliche PD-L1 Expressionen, Krankheitsdynamiken und Vortherapien eingeschlossen
• Patienten in Kohorte 2 und 4 müssen eine zusätzliche Anti-PD1-Behandlung vertragen können
• Patienten mit arzneimittelwirksamen Treibermutationen sollten nur eingeschlossen werden, wenn sie nicht für
  zugelassenen zielgerichteten Therapien in Frage kommen.
• (...)

Kontaktpersonen

elke.passmann@uk-koeln.de
juergen.wolf@uk-koeln.de

Ausschlusskriterien

• Laufende aktive systemische Behandlung eines NSCLC
• Aktueller Nachweis neuer oder wachsender Metastasen in Gehirn oder Rückenmark beim Screening. Patienten mit leptomeningealen Metastasen sind von der Teilnahme ausgeschlossen. 
• Patienten mit bekannten Hirn- oder
  Wirbelsäulenmetastasen können in Frage kommen, wenn sie:
  1. eine Strahlentherapie oder eine andere geeignete Therapie für die Hirn- oder Rückenmarksknochenmetastasen bekommen haben 
  2. keine neurologischen Symptome haben, die auf die aktuellen Hirnläsionen zurückgeführt werden können                                                                                                          3. eine stabile Erkrankung des Gehirns oder der Wirbelsäule auf dem CT- oder MRT-Scan innerhalb von 4 Wochen aufweisen                                                                                     4. innerhalb von 14 Tagen vor der ersten Dosis der Studienbehandlung keine Steroidtherapie benötigen
• (...) 

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Kontaktpersonen

juergen.wolf@uk-koeln.de
elisabeth.bitter@uk-koeln.de
sabine.hahne@uk-koeln.de

Ausschlusskriterien

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Patients should only enter the study if all of the following inclusion criteria are fulfilled: 1. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up. 3. Age ≥18 years and <75 years. 4. All sex and gender. 5. Female patients of childbearing potential as well as male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group (CTFG) during the course of this study and for at least 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last. 6. Evidence of post-menopausal status or negative serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. 7. Histologically proven NSCLC (EGFRm-, ALK-). 8. Selected patients with NSCLC stage IIIA/B: a. IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy T1/T2 N2. b. IIIB: one or more lymph node levels involved at EBUS/mediastinoscopy T3/T4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical/oncologic complete resectability (R0) at the time of inclusion. 11. Sufficient functional reserves for the planned surgery 12. Fulfilment of adequate criteria for functional and medical resectability as described in the European Respiratory Society (ERS)/ European Society of Thoracic Surgeons (ESTS) guidelines [Brunelli et al. 2009] and acceptable general clinical condition for multimodality treatment (interdisciplinary committee). 13. Life expectancy of >12 weeks. 14. Body weight >30 kg. 15. Adequate normal organ and bone marrow function as defined below: a. Hemoglobin ≥9.0 g/dL. b. Absolute neutrophil count (ANC) ≥1.5 × 109/L. c. Platelet count ≥100 × 109/L. d. Serum bilirubin ≤1.5 × institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician. e. Alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT) ≤2.5 × institutional ULN. f. Measured creatinine clearance (CL) ≥60 mL/min or calculated creatinine CL ≥60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24- hour urine collection for determination of creatinine clearance. 16. Stable cardiac function (no myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV). Patients should only be randomized if all of the following inclusion criteria are fulfilled at the time of randomization: 1. Given technical/oncologic complete resectability (R0) at the time of randomization. 2. Sufficient functional reserves for the planned surgery 3. Adequate normal organ and bone marrow function as defined before.

Ausschlusskriterien

Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+/ EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal involvement. 6. Patients with N3 tumors (IASLC/UICC 8). 7. Invasion of the thoracic aorta (T4 - aorta) or the heart (except left atrium - T4 - heart) or the esophagus (T4 - esophagus), or invasion of spine (T4 - spine) NOTE: T4 with invasion of diaphragm are eligible. 8. Pancoast-syndrome in tumors of the superior sulcus (T3-4 Nx). 9. Metastatic disease (M1). 10. Endobronchial tumor extension to the contralateral main stem bronchus. 11. Lung or heart function not allowing the intended surgical procedure at the time of inclusion. 12. Prior treatments including prior mediastinal irradiation. 13. Insufficient patients' compliance (e.g., symptomatic psychiatric disorder) or missing written informed consent or definitive refusal for participation. 14. Prior randomization of treatment in a previous durvalumab clinical study regardless of treatment arm assignment. 15. Patients who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4: a) Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy. b) All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study. c) Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic. d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of >10 mg prednisone or equivalent per day. 16. Participation in another clinical study with an investigational product during the last 12 months. 17. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 18. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. 19. Any concurrent chemotherapy (other than study therapy), Investigational Product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. 20. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab. 21. History of allogenic organ transplantation or a stem cell transplantation. 22. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: a. Vitiligo or alopecia b. Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Celiac disease controlled by diet alone e. Patients without active disease in the last 5 years may be included but only after consultation with the study physician 23. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 24. History of another primary malignancy except for a. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease 25. History of active primary immunodeficiency. 26. History of leptomeningeal carcinomatosis. 27. Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus (positive HIV-1 or HIV-2). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti- HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 28. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 90 days after the last dose of study treatment. 31. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last. 32. Known allergy or hypersensitivity to any of the study drugs or any of the study drugs excipient. 33. Any medical contraindication to treatment with platin-based doublet chemotherapy as listed in the applying SmPCs. 34. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. Patients should not be randomized if any of the following exclusion criteria are fulfilled at the time of randomization: 1. Complete remission after induction immunochemotherapy. 2. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous immunochemotherapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: a. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. b. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician (exception: alopecia). 3. Allergy or hypersensitivity to durvalumab or concurrent chemotherapy drugs or any excipient appearing for the first time during previous immunochemotherapy.

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

1. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory 2. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement 3. Patients who progressed after ≥ 24 weeks of first-line CT-ICI, including ≥12 weeks of anti-PD(L)1 as monotherapy or in combination with another ICI prior to randomization (i.e.; ICI secondary resistance); a radiological tumor assessment by the Investigator at 24 weeks (± 2 weeks) after the start of ICI is needed to exclude PD; induction treatment with first-line CT-ICI should contain at least 2 cycles of platinum-based CT except if contraindication to platinum

Ausschlusskriterien

1. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas) 2. Patients with known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel 3. Patients with PD during induction first-line CT-ICI (to exclude hyper progression and fast progression to CT-ICI) or with PD within 24 weeks of ICI; chemotherapy, other cytotoxic agent or antiangiogenics in combination with ICI within 12 weeks prior to randomization are not authorized; patients who stopped ICI due to toxicity or other reason than PD are not eligible

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Ausschlusskriterien

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Hystologisch bestätigter NSCLC mit homozygoter MTAP-Deletion

Fortgeschrittener oder metastasierter NSCLC, der nicht auf kurative Therapien anspricht, mit oder ohne nachgewiesene genetische Veränderungen nach Fortschreiten der Erkrankung nach früheren Therapien zum Zeitpunkt der Aufnahme in die Studie

Patienten ohne dokumentierte verwertbare genetische Veränderungen dürfen nur 1
vorherige Behandlung mit einem Checkpoint-Inhibitor und einer Chemotherapie auf Platinbasis gehabt haben

Patienten mit dokumentierten  genetischen Veränderungen dürfen nicht mehr als zwei vorherige systemische Therapielinien mit mindestens einer vorherigen zugelassenen zielgerichteten Therapie mit oder ohne platinbasierte Chemotherapie erhalten haben. Genetische Veränderungen schließen EGFR, ALK, NTRK, BRAF, ROS1, KRAS, MET exon 14 skipping, RET, and HER2 alterations ein.

Kontaktpersonen

juergen.wolf@uk-koeln.de

Ausschlusskriterien

Patienten ohne Plattenepithelkarzinom mit unbekanntem EGFR, ALK oder ROS1 Status

aktive Hirnmetastasen oder karzinomatöse Meningitis

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Auswahl:

Ausschlusskriterien

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements. Negative assay result is required for all non-squamous histology subtypes.

Ausschlusskriterien

Any prior systemic therapy received for advanced or mNSCLC

Diagnosen

Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]

Einschlusskriterien

Ausschlusskriterien