Klinische Studie
Krankheitsentität(en)
Lunge
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche EinschlusskriterienHistologically or cytologically documented squamous NSCLC.
Note: Tumors with a mixed adeno-squamous histology are eligible if, per the investigator’s opinion, the tumor should be treated as a squamous tumor.
3 Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
4 Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies. Note: Testing for genomic mutations is not mandated if not done as part of standard local practice.
5 WHO/ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
6 Minimum life expectancy of 12 weeks.
Wesentliche Ausschlusskriterien1 As judged by the investigator, any severe or uncontrolled systemic diseases, including, but not limited to, uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; ILD (of any grade), serious chronic gastrointestinal conditions associated with diarrhea (eg, active inflammatory bowel disease), active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment, psychiatric illness/social situations, substance abuse, or significant cardiac conditions which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
2 History of organ transplant.
3 Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
4 History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
5 Presence of small cell and neuroendocrine histology are exclusion criteria.
6 Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants may be enrolled with the following chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to the first dose of study intervention and managed withSoC treatment) which the investigator deems related to previous anticancer therapy: (a) Chemotherapy-induced neuropathy.
(b) Fatigue.
(c) Vitiligo.
(d) Endocrine disorders, that are controlled with replacement hormone therapy.
(e) Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator may be included (eg, hearing loss).
7 Spinal cord compression.
8 Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure).
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IIStudienzentrale0941 9444475pneumologie.studienzentrum(at)ukr.de