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- Klinische proef NCT07633873
SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC(SYNSTAR 04)
9 juni 2026 bijgewerkt door: CSPC Megalith Biopharmaceutical Co.,Ltd.
An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC
This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
Studietype
Ingrijpend
Inschrijving (Geschat)
500
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Clinical Trials Information Group officer
- Telefoonnummer: 031169085587
- E-mail: ctr-contact@cspc.cn
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Aged 18-75 (inclusive) years old, male or females;
- Participants with pathologically confirmed locally advanced or metastatic NSCLC. Including participants with stage IIIB or IIIC according to the 9th edition of AJCC staging who are not suitable for surgical resection or radical chemoradiotherapy, or participants with stage IV NSCLC
- Participants who have not previously received systemic anti-tumor treatment. Those who have previously received adjuvant/neoadjuvant therapy will be allowed for inclusion if disease progression occurs 12 months after the end of treatment.
- EGFR mutation negative and ALK fusion negative
- Participants with PD-L1 TPS≥1% according to centralized laboratory test
- At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
- ECOG performance status of 0-1;
- Life expectancy ≥ 3 months;
- Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
- Women of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the informed consent form until 7 months after the last dose; during this period, women should not be breastfeeding, and men should avoid donating sperm;
- Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.
Exclusion Criteria:
- Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
- Participants with ROS1/RET/NTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.
- Participants with meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastasis (i.e., without mesencephalon, pons, or medulla involvement) who have received local treatment, have achieved stability for at least 2 weeks prior to the first dose of the study intervention (imaging shows no new brain metastasis or enlargement of existing brain metastasis, and all neurologic symptoms have stabilized or returned to normal), and do not require corticosteroid therapy or are receiving prednisone at a daily dose of ≤10 mg or equivalent doses of other corticosteroids, can participate in the study;
- Participants with a history of other malignant tumors within 3 years prior to the first dose of the study intervention, except for the following conditions: cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, and cervical carcinoma in situ, etc.;
- Participants who are known to be allergic to any component of SYS6010, Enlonstobart, Tislelizumab or to humanized monoclonal antibody products or ; Paclitaxel/Carboplatin/ Pemetrexed/Cisplatin.
- Previously treated with topoisomerase I inhibitor toxin ADC therapy
- AEs caused by prior anti-tumor treatment have not recovered to ≤ Grade 1 (excluding Grade 2 alopecia and other toxicities judged by the investigator to have no safety risk) according to NCI-CTCAE v6.0; Participants who experienced ≥ grade 3 irAEs during previous treatment, or who permanently discontinued medication due to irAEs
- Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded;
- History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\
- Patients who have a history of ILD/non-infectious pneumonitis treated with corticosteroids in the past, currently have ILD/non-infectious pneumonitis, for whom imaging examinations at screening cannot rule out ILD/non-infectious pneumonitis, or whose pulmonary function test indicates severe ventilatory dysfunction and/or decreased diffusion capacity;
- Presence of severe infections within 4 weeks prior to the first dose of the study intervention, including but not limited to bacteraemia requiring hospitalisation, severe pneumonia, active pulmonary tuberculosis infection, etc.; presence of active infections requiring systemic antibiotics within 2 weeks prior to the first dose of the study intervention;
- Participants with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) are excluded, but participants with the following conditions are allowed to proceed to further enrollment screening: well-controlled type 1 diabetes and hypothyroidism that is well-controlled with only hormone replacement therapy.
- Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;
- Active HBV or HCV infection (hepatitis B surface antigen and/or hepatitis B core antibody positive and HBV DNA copies ≥ 1×10^4 copies/mL or ≥ 2000 IU/mL, HCV antibody positive and HCV RNA above the lower limit of detection of the analytical procedure). Note: For HBsAg-positive patients, it is recommended to start antiviral therapy before the first dose of the study intervention, nucleoside analogues are recommended, such as entecavir, tenofovir disoproxil;
- History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;
- Other conditions that the investigator deem unsuitable for participation in this clinical study. Such as mental illness, uncontrolled or poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥95 mmHg after standardized antihypertensive treatment), and diabetes, etc.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: SYS6010 combined with Enlonstobart group
SYS6010 injection and Enlonstobart injection will be administrated on a 21-day cycle.
|
SYS6010 is Lyophilized powder for injection as an EGFR-ADC.
SYS6010 will be administered via intravenous infusion, Q3W, with 21 days as one treatment cycle, at a dose of 4.5 mg/kg.
Enlonstobart is arecombinant human anti-PD-1 monoclonal antibody injection,and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 360 mg.
Andere namen:
|
|
Actieve vergelijker: Tislelizumab+ Platinum-based chemotherapy
For squamous NSCLC, Tislelizumab +Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle.
For nonsquamous NSCLC, Tislelizumab + Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.
|
Tislelizumab is a marketed recombinant human anti-PD-1 monoclonal antibody injection, and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 200 mg.
Andere namen:
Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin are widely accepted and common chemotherapy medication. For squamous NSCLC, Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle. For nonsquamous NSCLC, Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Progression Free Survival (PFS) assessed by IRC
Tijdsspanne: 2 years
|
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Algehele overleving (OS)
Tijdsspanne: 2 jaar
|
2 jaar
|
|
ORR assessed by investigators and IRC
Tijdsspanne: 1.5years
|
1.5years
|
|
DoR assessed by investigators and IRC
Tijdsspanne: 1.5years
|
1.5years
|
|
The Proportion of ADAanti-drug antibody positive of SYS6010 and Enlonstobart
Tijdsspanne: 1.5years
|
1.5years
|
|
The severity and frequency of Adverse Event (AE)and Serious Adverse Event (SAE) assessed by CTCAE v6.0.
Tijdsspanne: 2 years
|
2 years
|
|
Tmax of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
The Scale of Quality of Life assessed by participants
Tijdsspanne: 2 years
|
2 years
|
|
Cmax of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
AUC0-504h of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
t1/2 of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
CL of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
Vz of SYS6010 and Enlonstobart
Tijdsspanne: 1.5 years
|
1.5 years
|
|
DCR assessed by investigators and IRC
Tijdsspanne: 1.5 years
|
1.5 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
2 juni 2026
Primaire voltooiing (Geschat)
30 september 2027
Studie voltooiing (Geschat)
30 mei 2029
Studieregistratiedata
Eerst ingediend
31 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
5 juni 2026
Eerst geplaatst (Werkelijk)
8 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Carcinoom, niet-kleincellige long
- Aminozuren, peptiden en eiwitten
- Organische chemicaliën
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Coördinatiecomplexen
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamaten
- Aminozuren, zuur
- Aminozuren
- Aminozuren, dicarbonylisch
- Platinumverbindingen
- Pemetrexed
- Carboplatine
- Cisplatine
- tislelizumab
- CP -protocol
- TP -protocol
- AP protocol 1
Andere studie-ID-nummers
- SYS6010-022
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .