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Die klinische Studie NCT05756972 für Nicht-kleinzelliges Lungenkarzinom (NSCLC) ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC Phase 2 64
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05756972 untersucht Behandlung im Zusammenhang mit Nicht-kleinzelliges Lungenkarzinom (NSCLC). Diese interventionsstudie der Phase 2 hat den Status aktiv, nicht rekrutierend und startete am 26. Juni 2023. Es ist geplant, 64 Teilnehmer aufzunehmen. Durchgeführt von Biotheus Inc. wird der Abschluss für 1. Dezember 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. April 2025 aktualisiert.
Kurzbeschreibung
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.
Ausführliche Beschreibung
This study is a phase II, single-arm study, 64 participants were enrolled as of 6 Feb 2024, and recruitment was completed.
Offizieller Titel
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002(Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With EGFR-mutant Advanced Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment
Erkrankungen
Nicht-kleinzelliges Lungenkarzinom (NSCLC)Weitere Studien-IDs
- PM8002-BC010C-NSCLC-R
NCT-Nummer
Studienbeginn (tatsächlich)
2023-06-26
Zuletzt aktualisiert
2025-04-03
Studienende (vorauss.)
2025-12
Geplante Rekrutierung
64
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Aktiv, nicht rekrutierend
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellPM8002+Chemotherapy Subjects will be administered with PM8002 plus pemetrexed and carboplatin via intravenously (IV) Q3W for 4 cycles, followed by PM8002 and pemetrexed until progression or for a maximum of 2 years. | PM8002 IV infusion Carboplatin IV infusion Pemetrexed IV infusion |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Objective response rate (ORR) | Objective response rate is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to approximately 2 years |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Progression free survival (PFS) | Progression free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1). | Up to approximately 2 years |
Overall survival (OS) | OS is the time from the date of randomization or first dosing date to death due to any cause. | Up to approximately 2 years |
Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1. | Up to approximately 2 years |
Duration of response (DoR) | DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. | Up to approximately 2 years |
Time to response (TTR) | TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieve CR or PR (based on RECIST v1.1). | Up to approximately 2 years |
Pharmacokinetic (PK) parameters | The PK parameters include serum concentrations of PM8002 at different timepoints after study drug administration. | Up to 30 days after last treatment |
Anti-drug antibody(ADA) | To evaluate the incidence of ADA to PM8002 | Up to 30 days after last treatment |
Treatment related adverse events (TRAEs) | The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0 | Up to 30 days after last treatment |
Correlation between PD-L1 expression and antitumor effect | To evaluate correlation between PD-L1 expression and antitumor effect | Up to approximately 2 years |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Signed informed consent form before any trial-related processes.
- Age ≥ 18 years male or female.
- Have a histologically or cytologically confirmed stage IIIB/IIIC NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic non-squamous NSCLC (IV).
- with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment.
- EGFR-TKI resistance, confirmed by RECIST v1.1.
- have adequate organ function.
- The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
- Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.
- Have other driving gene mutations that can obtain effective treatment.
- Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC.
- Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs.
- Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs
- Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs.
- Evidence and history of severe bleeding tendency or coagulation dysfunction.
- The toxicity of previous anti-tumor therapy has not been alleviated.
- Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
- Have suffered from the second primary active malignant tumor in the past 5 years.
Biotheus Inc.Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern
Guangdonng
Medical Ethics Committee of Guangdong Provincial People's Hospital, Guangzhou, Guangdonng, 519041, China