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NCT06927986
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
Phase 3 trial testing SYS6010 in EGFR-mutated Locally Advanced or Metastatic NSCLC in 380 participants. Currently enrolling.
30 July 2026
Quick facts
| Lead sponsor | CSPC Megalith Biopharmaceutical Co.,Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 380 |
| Start date | 30 March 2025 |
| Primary completion | 30 July 2026 |
| Estimated completion | 30 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- SYS6010
- Pemetrexed — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- EGFR-mutated Locally Advanced or Metastatic NSCLC — all drugs for EGFR-mutated Locally Advanced or Metastatic NSCLC →
Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with EGFR-mutated Locally Advanced or Metastatic NSCLC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibody-drug conjugates in cancer therapy: current advances and prospects for breakthroughs.
Wu D, Yang K, He R, Yin R, et al · · 2025 · cited 2× · PMID 41133214 · DOI 10.3389/fcell.2025.1669592 -
Frontiers in Antibody-Drug Conjugates: Mechanisms, Design Innovations, and Clinical Applications in Targeted Cancer Therapy.
Li X, Liu J, Meng Y, Li J, et al · · 2026 · PMID 41754865 · DOI 10.3390/ph19020324
Verify or expand the search:
- PubMed search for NCT06927986
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SYS6010
Trials testing the same drug.
- NCT07406542 — A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer · Phase 3 · not yet recruiting
- NCT07417735 — SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
- NCT07442565 — SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ · Phase 3 · not yet recruiting
- NCT07376382 — A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCL · Phase 3 · not yet recruiting
- NCT07256509 — A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Muta · Phase 2 · not yet recruiting
Other CSPC Megalith Biopharmaceutical Co.,Ltd. trials
Trials by the same sponsor.
- NCT07374549 — SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma · Phase 2 · not yet recruiting
- NCT07526792 — SYS6002 vs Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma · Phase 3 · not yet recruiting
- NCT07591285 — A Study of SYS6051 in Subjects With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT07406542 — A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer · Phase 3 · not yet recruiting
- NCT07417735 — SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06927986 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSPC Megalith Biopharmaceutical Co.,Ltd.
- Last refreshed: 17 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06927986.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing