EGFR Positive Non-small Cell Lung CancerEarly Phase 1NCT06208033
SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)
A Early Phase 1 study testing SMET12 in people with EGFR Positive Non-small Cell Lung Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer
- What is being tested?
- SMET12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 30 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Being tested
- SMET12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMET12Drug
Also called toripalimab, Pemetrexed Disodium, Carboplatin
- 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;
- Toripalimab, IV, 3mg/kg，Q2W；
- SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
SMET12Drug
Also called toripalimab, paclitaxel, cisplatin
- 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;
- Toripalimab, IV, 3mg/kg，Q2W；
- SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
SMET12Drug
Also called toripalimab, Docetaxel
- chemotherapy：Docetaxel 60-75 mg/m2 d1, administrated for 2-4 cycles, 3 weeks for one cycle.
- Toripalimab, IV, 3mg/kg，Q2W；
- SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: SMET12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse events
Adverse events incidence refers to the frequency of adverse events
Measured: 1 year
rate of adverse events
All adverse events will also be rated based on the NCI CTCAE version 5.0.
Measured: 1 year
Laboratory aberrations
Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.
Measured: 1 year
Secondary outcomes (3)
disease control rate
Disease control rate: DCR
Measured: 1 year
Progression-free survival
Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
Measured: 1 year
DOR（ Duration of Response）
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start10 Jan 2024 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208033
- Sponsor's protocol ID
- SCOG009
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41583476
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06208033
- Acronym / sponsor ID
- SCOG009
- Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma | Experimental | Drug: SMET12toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Pemetrexed Disodium 500mg/m2 d+Carboplatin AUV＝5 d1 Q3W，administered for 2~4 cycles |
| Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma | Experimental | Drug: SMET12toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； paclitaxel 100mg/m2 d1，d8，d15+cisplatin 75mg/m2 d1 Q3W， administered for 2~4 cycles |
| Subjects resistant to first-line treatment contain immune checkpoint inhibitors | Experimental | Drug: SMET12toripalimab：3mg/kg， Q2W； SMET12：60μg，Q2W； Docetaxel 60-75 mg/m2 d1Q3W，administered for 2~4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMET12Also: toripalimab, Pemetrexed Disodium, Carboplatin1. 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 | Treatment-naïve subjects with EGFR positive advanced Lung Adenocarcinoma |
| SMET12Also: toripalimab, paclitaxel, cisplatin1. 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 | Treatment-naïve subjects with EGFR positive advanced Lung Squamous Cell Carcinoma |
| SMET12Also: toripalimab, Docetaxel1. 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 ； | Drug | Subjects resistant to first-line treatment contain immune checkpoint inhibitors |
Primary outcome
incidence of adverse events
Time frame: 1 year
Adverse events incidence refers to the frequency of adverse events
rate of adverse events
Time frame: 1 year
All adverse events will also be rated based on the NCI CTCAE version 5.0.
Laboratory aberrations
Time frame: 1 year
Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.
3 secondary outcomes
disease control rate
Time frame: 1 year
Progression-free survival
Time frame: 1 year
DOR（ Duration of Response）
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 41583476Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SMET12 in people with EGFR Positive Non-small Cell Lung Cancer, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong He (+86 138 0508 6391, heyong1015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse events (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.