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

NCT06208033 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-17

No results posted yet for this study

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

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 ；

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2024-10-20
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06208033 on ClinicalTrials.gov