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

January 5, 2024 updated by: Fujian Cancer Hospital

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Fuzhou, China
        • Fujian Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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 ；
Other Names:
  • Carboplatin
  • Pemetrexed Disodium
  • 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 ；
Other Names:
  • cisplatin
  • paclitaxel
  • 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 ；
Other Names:
  • Docetaxel
  • toripalimab
Experimental: 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
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 ；
Other Names:
  • Carboplatin
  • Pemetrexed Disodium
  • 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 ；
Other Names:
  • cisplatin
  • paclitaxel
  • 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 ；
Other Names:
  • Docetaxel
  • toripalimab
Experimental: 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
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 ；
Other Names:
  • Carboplatin
  • Pemetrexed Disodium
  • 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 ；
Other Names:
  • cisplatin
  • paclitaxel
  • 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 ；
Other Names:
  • Docetaxel
  • toripalimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of adverse events
Time Frame: 1 year
Adverse events incidence refers to the frequency of adverse events
1 year
rate of adverse events
Time Frame: 1 year
All adverse events will also be rated based on the NCI CTCAE version 5.0.
1 year
Laboratory aberrations
Time Frame: 1 year
Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate
Time Frame: 1 year
Disease control rate: DCR
1 year
Progression-free survival
Time Frame: 1 year
Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
1 year
DOR（ Duration of Response）
Time Frame: 1 year
Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2024

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCOG009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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