SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)

EGFR Positive Non-small Cell Lung Cancer Clinical Trial

Official title:

A Single-arm, Sequential Study Assessing the Efficacy and Safety of SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208033
• Other study ID #: SCOG009
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 10, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Fujian Cancer Hospital
• Contact: Zhiyong He
• Phone: +86 138 0508 6391
• Email: heyong1015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures.

2. Age = 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry = [+]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period > 3 months).

4. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival = 3 months. 7. Adequate organ function .

Exclusion Criteria:

• 1. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy.

4. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator.

6. Fertile individuals unable to maintain effective contraception during the trial.

7. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors.

9. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• SMET12
platinum-containing two-drug chemotherapy:Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, three weeks for one cycyles;Carboplatin 500mg/m2 d1,Pemetrexed Disodium AUV=5 d1,Q3W; Toripalimab, IV, 3mg/kg,Q2W; SMET12: IV,60µg,Q2W,injected the day after toripalimab ;
• SMET12
platinum-containing two-drug chemotherapy:Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, 3 weeks for one cycle.cisplatin 75mg/m2 d1 Q3W,paclitaxel 100mg/m2 d1,d8,d15; Toripalimab, IV, 3mg/kg,Q2W; SMET12: IV,60µg,Q2W,injected the day after toripalimab ;
• SMET12
chemotherapy:Docetaxel 60-75 mg/m2 d1, administrated for 2-4 cycles, 3 weeks for one cycle. Toripalimab, IV, 3mg/kg,Q2W; SMET12: IV,60µg,Q2W,injected the day after toripalimab ;

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of adverse events	Adverse events incidence refers to the frequency of adverse events	1 year
Primary	rate of adverse events	All adverse events will also be rated based on the NCI CTCAE version 5.0.	1 year
Primary	Laboratory aberrations	Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.	1 year
Secondary	disease control rate	Disease control rate: DCR	1 year
Secondary	Progression-free survival	Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria	1 year
Secondary	DOR( Duration of Response)	Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first.	1 year