Non-Small Cell Lung CancerPhase 2NCT07256509
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer
A Phase 2 study testing SYS6010, Osimertinib and Pemetrexed in people with Non-Small Cell Lung Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- SYS6010, Osimertinib and Pemetrexed
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the written informed consent form (ICF);
- Age 18-75 years, regardless of sex;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;
- Must be eligible for complete surgical resection of the primary tumor;
- Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;
- Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility;
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- No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy);
- At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥6 months;
- Adequate major organ and bone marrow function;
- Women or men of childbearing potential must use highly effective contraception.
- 1. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Age 18-75 years, regardless of sex; 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria; 4. Must be eligible for complete surgical resection of the primary tumor; 5. Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT; 6. Confirmed presence of an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation, co-mutation with other EGFR sites is allowed), as tested by a central laboratory or local testing facility; 7. No prior systemic anti-tumor therapy (including chemotherapy, biotherapy, targeted therapy, immunotherapy); 8. At least one measurable lesion at baseline as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 10. Life expectancy ≥6 months; 11. Adequate major organ and bone marrow function; 12. Women or men of childbearing potential must use highly effective contraception.
Who cannot join
- Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;
- Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;
- T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and/or bulky N2 disease;
- Eligible only for segmentectomy or wedge resection;
- Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;
- Major surgery or severe traumatic injury within 4 weeks before the first study treatment, or expected to undergo major surgery during the study period;
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- History of other primary malignant tumor (including any known or suspected concurrent primary lung cancer);
- History of autoimmune disease, immunodeficiency, or organ transplant (except for corneal transplant);
- Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
- Evidence of severe or uncontrolled medical conditions (including uncontrolled hypertension, diabetes mellitus, etc,);
- Active or prior history of interstitial lung disease (ILD)/pneumonitis;
- Expected to receive live vaccine therapy within 30 days after randomization;
- History of a definite neurological or mental disorder; known allergy, hypersensitivity, or intolerance to the study drugs or any of their excipients;
- Pregnant or lactating women;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive
To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.
Read the detailed description
This study includes three stages: a neoadjuvant therapy stage, a surgery stage, and an adjuvant follow-up stage. In the neoadjuvant therapy stage, eligible participants will be stratified by stage (Stage II and Stage III) and mutation type (19Del and L858R) and randomized in a 1:1 ratio to the SYS6010 combined with osimertinib treatment group and the osimertinib monotherapy group. Neoadjuvant therapy will be administered for 3 cycles.
In the surgery stage, the feasibility of surgery will be assessed by a thoracic surgery investigator. Surgery should be performed between Week 10 and Week 12 (i.e., D64-D84 after the first dose of neoadjuvant therapy). Tumor samples collected during surgery will be sent to a central pathology laboratory to assess pathological response.
In the adjuvant therapy stage, all participants who undergo surgery will subsequently enter the adjuvant therapy stage. Participants who do not undergo surgery for reasons other than disease progression will also enter the adjuvant therapy stage.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SYS6010, Osimertinib, Pemetrexed, Cisplatin, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010 by intravenous (IV) infusion
OsimertinibDrug
Also called Osimertinib Mesylate Tablets
Osimertinib, oral
PemetrexedDrug
500 mg/m^2 by IV infusion, Q3W
CisplatinDrug
75 mg/m^2 by IV infusion, Q3W
CarboplatinDrug
AUC 5 mg/mL•min by IV infusion, Q3W
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 + Osimertinib | Experimental | Neoadjuvant Therapy: SYS6010 + Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin Receives: Drug: SYS6010; Drug: Osimertinib |
| Osimertinib | Active comparator | Neoadjuvant Therapy: Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin Receives: Drug: Osimertinib; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) Rate
Defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor bed, as assessed by blinded independent pathological review (BIPR).
Measured: Within 8 weeks post-surgery
Pathological Complete Response (pCR) Rate
The proportion of participants with no residual viable tumor cells in both the resected primary tumor bed and lymph nodes, as assessed by BIPR.
Measured: Within 8 weeks post-surgery
Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery
Measured: Within 8 weeks post-surgery
Disease-Free Survival (DFS)
Investigator-assessed DFS per RECIST v1.1
Measured: Up to approximately 5.5 years after the last participant enrolled
Event-Free Survival (EFS)
Investigator-assessed DFS per RECIST v1.1
Measured: Up to approximately 5.5 years after the last participant enrolled
Objective Response Rate (ORR)
Investigator-assessed ORR per RECIST v1.1
Measured: Up to approximately 5.5 years after the last participant enrolled
Overall Survival (OS)
Measured: Up to approximately 5.5 years after the last participant enrolled
Incidence of Adverse Events (AEs)
Measured: Up to approximately 5.5 years after the last participant enrolled
Anti-drug Antibodies (ADAs) to SYS6010
Measured: Up to approximately 5.5 years after the last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open-label, Phase II
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256509
- Sponsor's protocol ID
- SYS6010-013
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of SYS6010 Combined With Osimertinib Versus Osimertinib as Neoadjuvant Therapy in Participants With Resectable Stage II-IIIB Non-squamous Non-small Cell Lung Cancer With EGFR Mutation Positive
- ClinicalTrials.gov ID
- NCT07256509
- Acronym / sponsor ID
- SYS6010-013
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of SYS6010 combined with osimertinib as neoadjuvant therapy for patients with resectable EGFR mutation non-squamous non-small cell lung cancer.
Detailed description
This study includes three stages: a neoadjuvant therapy stage, a surgery stage, and an adjuvant follow-up stage. In the neoadjuvant therapy stage, eligible participants will be stratified by stage (Stage II and Stage III) and mutation type (19Del and L858R) and randomized in a 1:1 ratio to the SYS6010 combined with osimertinib treatment group and the osimertinib monotherapy group. Neoadjuvant therapy will be administered for 3 cycles.
In the surgery stage, the feasibility of surgery will be assessed by a thoracic surgery investigator. Surgery should be performed between Week 10 and Week 12 (i.e., D64-D84 after the first dose of neoadjuvant therapy). Tumor samples collected during surgery will be sent to a central pathology laboratory to assess pathological response.
In the adjuvant therapy stage, all participants who undergo surgery will subsequently enter the adjuvant therapy stage. Participants who do not undergo surgery for reasons other than disease progression will also enter the adjuvant therapy stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-label, Phase II
| Arm | Type | Receives |
|---|---|---|
| SYS6010 + Osimertinib | Experimental | Drug: SYS6010, Drug: OsimertinibNeoadjuvant Therapy: SYS6010 + Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin |
| Osimertinib | Active comparator | Drug: Osimertinib, Drug: Pemetrexed, Drug: Cisplatin, Drug: CarboplatinNeoadjuvant Therapy: Osimertinib Adjuvant Therapy: Osimertinib + Pemetrexed + Cisplatin or Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to understand and voluntarily sign the written informed consent form (ICF);
- Age 18-75 years, regardless of sex;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer, staged as resectable or potentially resectable Stage II-IIIB disease according to the International Association for the Study of Lung Cancer (IASLC) 8th Edition TNM staging criteria;
- Must be eligible for complete surgical resection of the primary tumor;
- Nodal status must be evaluated by whole-body FDG-PET and contrast-enhanced CT;
Key exclusion criteria (14 listed)
- Diagnosis of Stage I, Stage IIIB with N3, and Stage IIIC, IVA, and IVB non-small cell lung cancer;
- Multiple primary malignancies (refer to exclusion criterion #8 for synchronous primary lung cancer) OR a mixed histology of SCLC and NSCLC;
- T4 stage lung cancer due to invasion of the great vessels, carina, trachea, esophagus, heart, or vertebral body; and/or bulky N2 disease;
- Eligible only for segmentectomy or wedge resection;
- Receipt of Chinese patent medicine preparations indicated for the treatment of lung cancer within 1 week before randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6010SYS6010 by intravenous (IV) infusion | Drug | SYS6010 + Osimertinib |
| OsimertinibAlso: Osimertinib Mesylate TabletsOsimertinib, oral | Drug | Osimertinib, SYS6010 + Osimertinib |
| Pemetrexed500 mg/m^2 by IV infusion, Q3W | Drug | Osimertinib |
| Cisplatin75 mg/m^2 by IV infusion, Q3W | Drug | Osimertinib |
| CarboplatinAUC 5 mg/mL•min by IV infusion, Q3W | Drug | Osimertinib |
Primary outcome
Major Pathological Response (MPR) Rate
Time frame: Within 8 weeks post-surgery
Defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor bed, as assessed by blinded independent pathological review (BIPR).
Pathological Complete Response (pCR) Rate
Time frame: Within 8 weeks post-surgery
The proportion of participants with no residual viable tumor cells in both the resected primary tumor bed and lymph nodes, as assessed by BIPR.
Downstaging from N2 to N0/N1 or N1 to N0 at the time of surgery
Time frame: Within 8 weeks post-surgery
Disease-Free Survival (DFS)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Investigator-assessed DFS per RECIST v1.1
Event-Free Survival (EFS)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Investigator-assessed DFS per RECIST v1.1
Objective Response Rate (ORR)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Investigator-assessed ORR per RECIST v1.1
Overall Survival (OS)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Incidence of Adverse Events (AEs)
Time frame: Up to approximately 5.5 years after the last participant enrolled
Anti-drug Antibodies (ADAs) to SYS6010
Time frame: Up to approximately 5.5 years after the last participant enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYS6010, Osimertinib and Pemetrexed in people with Non-Small Cell Lung Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (+86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) Rate (time frame: Within 8 weeks post-surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.