NCT06208033

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

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.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• EGFR Positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SMET12	1. 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; 2. Toripalimab, IV, 3mg/kg，Q2W； 3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
DRUG	SMET12	1. 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; 2. Toripalimab, IV, 3mg/kg，Q2W； 3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
DRUG	SMET12	1. chemotherapy：Docetaxel 60-75 mg/m2 d1, administrated for 2-4 cycles, 3 weeks for one cycle. 2. Toripalimab, IV, 3mg/kg，Q2W； 3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-10-20
• Completion: 2024-12-30
• First posted: 2024-01-17
• Last updated: 2024-01-17

Locations

1 site across 1 country: China