Klinische Studie
Krankheitsentität(en)
Lunge
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche EinschlusskriterienStage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
4 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.
Note: Testing should be carried out locally; if unavailable, central testing is allowed. Central testing results for EGFR, ALK and/or ROS1 obtained during screening from another AstraZeneca study may be used.
5 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 other genomic mutations is not mandated if not done as part of standard local practice.
Provision of acceptable tumor sample, as defined in the Pathology Manual and Laboratory Manual and summarized in Section 8.8, to confirm tumor PD-L1 expression TC ≥ 1% using the VENTANA PD-L1 (SP263) Assay at a Sponsor-designated central laboratory prior to randomization. Participants with unknown PD-L1 status or TC < 1% are not eligible for the study. Note: If PD-L1 status has already been assessed using the VENTANA PD-L1 (SP263) Assay as part of screening for another AstraZeneca study, this test result may be used if the sample requirements are met.
Wesentliche AusschlusskriterienAs 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.
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