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

NCT ID: NCT06208033

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma

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

Group Type: EXPERIMENTAL

SMET12

Intervention Type: 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 ；

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

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

Group Type: EXPERIMENTAL

SMET12

Intervention Type: DRUG

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 ；

Subjects resistant to first-line treatment contain immune checkpoint inhibitors

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

Group Type: EXPERIMENTAL

SMET12

Intervention Type: DRUG

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 ；

Interventions

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 ；

Intervention Type: 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 ；

Intervention Type: 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 ；

Intervention Type: DRUG

Other Intervention Names

toripalimab; Pemetrexed Disodium; Carboplatin; toripalimab; paclitaxel; cisplatin; toripalimab; Docetaxel

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital

Fuzhou, , China

Countries

China

Central Contacts

Zhiyong He

Role: CONTACT

heyong1015@163.com

+86 138 0508 6391

Other Identifiers

SCOG009

Identifier Type: -

Identifier Source: org_study_id