Health TrialsbyHealthPanel

Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）

ConditionEGFR-mutated Locally Advanced or Metastatic NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 (inclusive) years old, male or females;

Patients with pathologically confirmed locally advanced or metastatic NSCLC, including those with stage IIIB or IIIC based on 8th edition of the AJCC staging system who are not suitable for surgical resection or radical chemoradiotherapy, or those with stage IV NSCLC. Patients with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy，whereas patients progressed on first- or second-generation EGFR-TKIs must have also progressed on third-generation EGFR-TKIs if T790M mutation was detected as postive status.

Presence of at least one EGFR-sensitive mutation;

At least one measurable lesion confirmed by CT or MRI scan according to RECIST v1.1 criteria;

Disqualifiers

Histologically or cytologically confirmed combined small cell lung cancer,squamous cell carcinoma, neuroendocrine carcinoma,or carcinosarcoma

Patients 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 randomization (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;

Patients with a history of other malignant tumors within 3 years prior to randomization, 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.;

Patients who are known to be allergic to any component of SYS6010 or to humanized monoclonal antibody products; allergic to carboplatin, cisplatin, or pemetrexed, or have contraindications for their use;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SYS6010

    Drug

    SYS6010,Q3W

  • Pemetrexed

    Drug

    Pemetrexed injection 500 mg/m\^2 administered via intravenous infusion，Q3W

  • Cisplatin

    Drug

    Cisplatin 75 mg/m\^2 administered via intravenous infusion，Q3W

  • Carboplatin

    Drug

    Carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: SYS6010Experimental treatment 1 intervention
Group B: Platinum-containing chemotherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) assessed by independent review committee (IRC)

Defined as the time from randomisation until the date of objective disease progression or death was assessed by IRC according to RECIST 1.1

Time frame
Up to approximately 1.5 years

Secondary outcomes

1

Investigator-assessed PFS

Defined as the time from randomisation until the date of objective disease progression or death was assessed by investigator according to RECIST 1.1

Time frame
Up to approximately 1.5 years
2

Disease Control Rate (DCR)

Defined as the percentage of subjects who have a best overall response of CR or PR or SD based on IRC and investigator according to RECIST 1.1

Time frame
Up to approximately 2 years
3

Objective response rate (ORR)

: Defined as the proportion of patients with response (including CR and PR) assessed by the investigator and the IRC according to RECIST v1.1.

Time frame
Up to approximately 1.5 years
4

Overall Survival (OS)

Defined as the time from randomization until death from any cause

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now