Recruiting

SYS6010 in EGFR-Mutated NSCLC After EGFR TKI Failure

What is being tested

SYS6010

+ Pemetrexed

+ Cisplatin

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 75 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2025

See protocol details

Summary

Principal SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

Study ContactClinical Trials Information Group officer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 30, 2025

Actual date on which the first participant was enrolled.

This clinical study focuses on patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. These patients have already tried a treatment known as EGFR TKI, but it didn't work for them. The study aims to compare a new drug, SYS6010, with a standard treatment using platinum-based chemotherapy. The goal is to find out which treatment is more effective and safer for these patients, potentially offering a better option for those whose cancer has advanced or spread. Participants in the study will be randomly assigned to receive either the new drug SYS6010 or the standard chemotherapy. The study is open-label, meaning both the doctors and patients know what treatment is being given. Researchers will closely monitor the patients to evaluate how well each treatment works and any side effects that occur. By comparing the outcomes, the study seeks to gather important information that could help improve treatment strategies for people with this challenging form of lung cancer.

Official TitleA Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment

NCT06927986

Principal SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

Study ContactClinical Trials Information Group officer

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

380 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

9 inclusion criteria required to participate

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;

Show More Criteria

17 exclusion criteria prevent from participating

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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Pemetrexed injection 500 mg/m\^2 + cisplatin 75 mg/m\^2 or carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Shanghai Chest Hospital

Shanghai, ChinaOpen Shanghai Chest Hospital in Google Maps

Recruiting

One Study Center