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

NCT06208033 | Unknown Early Phase 1

• 1 other identifier: SCOG009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• incidence of adverse events

  Adverse events incidence refers to the frequency of adverse events

  1 year

• rate of adverse events

  All adverse events will also be rated based on the NCI CTCAE version 5.0.

  1 year

• Laboratory aberrations

  Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.

  1 year

Secondary Outcomes (3)

• disease control rate

  1 year

• Progression-free survival

  1 year

• DOR（ Duration of Response）

  1 year

Study Arms (3)

Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma

EXPERIMENTAL

toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Pemetrexed Disodium 500mg/m2 d+Carboplatin AUV＝5 d1 Q3W，administered for 2\~4 cycles

Drug: SMET12

Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma

EXPERIMENTAL

toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； paclitaxel 100mg/m2 d1，d8，d15+cisplatin 75mg/m2 d1 Q3W， administered for 2\~4 cycles

Drug: SMET12

Subjects resistant to first-line treatment contain immune checkpoint inhibitors

EXPERIMENTAL

toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Docetaxel 60-75 mg/m2 d1Q3W，administered for 2\~4 cycles

Drug: SMET12

Interventions

SMET12 DRUG

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 ；

Also known as: toripalimab, Pemetrexed Disodium, Carboplatin

Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Fertile individuals unable to maintain effective contraception during the trial.
• \. 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.
• \. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, China

Location

Related Publications (1)

• Lin J, Chen S, Li M, Weng L, Xu H, Wang Q, Zhang J, Lin D, Wang H, Liu Q, He Z. Efficacy and safety of SMET12 in combination with toripalimab and chemotherapy in advanced non-small-cell lung cancer patients tested positive for EGFR protein who are treatment-naive or harbor acquired resistance to standard therapy: a phase 2, multi-cohort clinical trial. Front Immunol. 2026 Jan 8;16:1706961. doi: 10.3389/fimmu.2025.1706961. eCollection 2025.

  PMID: 41583476 DERIVED

MeSH Terms

Interventions

toripalimab; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Zhiyong He

CONTACT

+86 138 0508 6391; heyong1015@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 10, 2024
• Primary Completion: October 20, 2024
• Study Completion: December 30, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

CN (1)