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

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: EGFR Positive Non-small Cell Lung Cancer

Treatments: Drug: SMET12

Study type: Interventional

Funder types: Other

Identifiers

NCT06208033

SCOG009

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

  3. 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.

  2. 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.

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

  4. 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.

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 3 patient groups

Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma

Experimental group

Description:

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

Treatment:

Drug: SMET12

Drug: SMET12

Drug: SMET12

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

Experimental group

Description:

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

Treatment:

Drug: SMET12

Drug: SMET12

Drug: SMET12

Subjects resistant to first-line treatment contain immune checkpoint inhibitors

Experimental group

Description:

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

Treatment:

Drug: SMET12

Drug: SMET12

Drug: SMET12