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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 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Clinical Trials Information Group officer
  • Telefonnummer: 031169085587
  • E-mail: ctr-contact@cspc.cn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged 18-75 (inclusive) years old, male or females;
  2. 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
  3. 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.
  4. EGFR mutation negative and ALK fusion negative
  5. Participants with PD-L1 TPS≥1% according to centralized laboratory test
  6. At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria
  7. ECOG performance status of 0-1;
  8. Life expectancy ≥ 3 months;
  9. Major organ function must meet the criteria within 7 days prior to the first dose of the study intervention
  10. 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;
  11. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign a written informed consent form.

Exclusion Criteria:

  1. Histology or cytology of the tumor confirms the presence of combined small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
  2. Participants with ROS1/RET/NTRK fusions, MET exon 14 skipping mutation, or BRAF V600E mutation.
  3. 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;
  4. 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.;
  5. 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.
  6. Previously treated with topoisomerase I inhibitor toxin ADC therapy
  7. 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
  8. Patients who have not met the corresponding washout period requirements for the medications or treatments should be excluded;
  9. History of severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose of the study intervention\
  10. 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;
  11. 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;
  12. 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.
  13. Pleural effusion or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose;
  14. 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;
  15. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), history of allogeneic stem cell or organ transplant;
  16. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • SG001
Aktiv komparator: 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.
Andre navne:
  • Tevimbra

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.

Andre navne:
  • TP regimen or AP regimen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression Free Survival (PFS) assessed by IRC
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse (OS)
Tidsramme: 2 år
2 år
ORR assessed by investigators and IRC
Tidsramme: 1.5years
1.5years
DoR assessed by investigators and IRC
Tidsramme: 1.5years
1.5years
The Proportion of ADAanti-drug antibody positive of SYS6010 and Enlonstobart
Tidsramme: 1.5years
1.5years
The severity and frequency of Adverse Event (AE)and Serious Adverse Event (SAE) assessed by CTCAE v6.0.
Tidsramme: 2 years
2 years
Tmax of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
The Scale of Quality of Life assessed by participants
Tidsramme: 2 years
2 years
Cmax of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
AUC0-504h of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
t1/2 of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
CL of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
Vz of SYS6010 and Enlonstobart
Tidsramme: 1.5 years
1.5 years
DCR assessed by investigators and IRC
Tidsramme: 1.5 years
1.5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. juni 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. maj 2029

Datoer for studieregistrering

Først indsendt

31. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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