Letzte Aktualisierung: 06.05.2026
Nicht-Kleinzelliges Bronchialkarzinom (NSCLC) [C34]
C5851005
Studieninformationen
Eine randomisierte, offene Phase-III-Studie zur Beurteilung von PF-08046054/SGN-PDL1V im Vergleich zu Docetaxel bei erwachsenen Teilnehmern mit vorbehandeltem PD-L1-positivem nicht-kleinzelligem Bronchialkarzinom (NSCLC)
Ziele
Primäres Prüfziel
Gesamtüberleben
Sekundäre Prüfziele für die Behandlungsarme:
Progressionsfreies Überleben
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
PD-L1 >= 1%
Mutation
Patienten
Alter
Einschlusskriterien
Auswahl:
Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced,
unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or
metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on
Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer
Control (UICC) Staging System. Note: Participants with a neuroendocrine component or
histology are not eligible.
PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC)
testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or
SP263
Participants who have NSCLC with known AGAs are permitted.
Participants must have received the following therapies and progressed during or relapsed
after receiving their most recent prior therapy, or have been intolerant to their most recent
therapy:
- Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody
(concurrently or sequentially with platinum-based chemotherapy).
- Experienced disease progression within 6 months of the last dose of platinumbased
chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting
and received a PD-(L)1 monoclonal antibody at any time during the course of
treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other
relevant actionable mutations) must fulfill the following conditions:
- Must have received at least 1 relevant AGA-targeted therapy if locally available
and, in the opinion of the investigator, additional AGA-targeted therapy is not in
the best interest of the participant
- Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, or experienced disease progression within 6 months of the last
dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or
chemoradiotherapy setting.
- May have received PD-(L)1 monoclonal antibody (concurrently or sequentially
with platinum-based chemotherapy).
Ausschlusskriterien
Participants with a history of leptomeningeal metastasis are excluded.
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within
5 half-lives.
Previous receipt of an MMAE-containing agent or prior docetaxe
Therapie
Intervention
Substanz
| Prüfplancode | C5851005 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT07144280 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
—
Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)