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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)

2026년 6월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

500

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Clinical Trials Information Group officer
  • 전화번호: 031169085587
  • 이메일: ctr-contact@cspc.cn

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • SG001
활성 비교기: 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.
다른 이름들:
  • 테빔브라

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.

다른 이름들:
  • TP regimen or AP regimen

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Progression Free Survival (PFS) assessed by IRC
기간: 2 years
2 years

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 2일

기본 완료 (추정된)

2027년 9월 30일

연구 완료 (추정된)

2029년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 31일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

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미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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