NSCLCPhase 2NCT06221670
Toripalimab Therapy After Resection in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK)
A Phase 2 study testing Toripalimab in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 20 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The subjects will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
- Male and female, ≥18 years old;
- Primary non-squamous NSCLC confirmed histologically by the central laboratory;
- The subject was clinically confirmed as stage IA2-IB by imaging with tumor lesion size > 2 cm;
- As confirmed by the central laboratory, the tumor contains no common EGFR mutations and ALK fusion variants;
- The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS);
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- Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, and/or STAS, and/or pleural invasion, and/or poorly differentiated, and/or complex glands ≥ 10%; PD-L1 TPS ≥ 1% in tumor tissue;
- WHO physical status score is 0~1;
- Paraffin-embedded sections (10-15 sheets), or wax blocks or fresh frozen tissue for surgical resection of the lesion should be provided;
- Adequate bone marrow reserve or organ function (demonstrated by any of the following laboratory values: absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; Alanine aminotransferase ≤ 2.5 ULN; Aspartate aminotransferase ≤2.5 times ULN; Total bilirubin ≤ 1.5 ULN; Serum creatinine ≤1.5 ULN with creatinine clearance ≥60 mL/min [as measured or calculated by Cockcroft and Gault formulas]);
- At least 2 weeks prior to initiation of the study drug, female subjects should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to initiation of the drug
- Subjects voluntarily join this study, with good compliance and cooperation in safety and survival follow-up.
Who cannot join
- Exposure to other antitumor therapies before enrollment;
- Patients who only received segmental resection and wedge resection;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids;
- Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;
- Any evidence of prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or active interstitial lung disease;
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- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any condition that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);
- Have received preventive or attenuated vaccines within 4 weeks before the first administration;
- Patients are unsuitable for participation in this research after comprehensive assessment by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Dongsheng Yue
About this study
Official title: Efficacy and Safety of Toripalimab Adjuvant Therapy in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK) After Complete Resection: a Prospective, Single-arm Study
This is a prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
- Conditions
- NSCLC
- Being tested
- Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
This is a prospective, open, single-center, single-arm phase II clinical study with no driver mutations identified in the central laboratory，to evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab adjuvant therapy group | Experimental | Patients must be enrolled within 8 weeks of complete surgical excision and receive Toripalimab at a dose of 240 mg intravenously (IV) once every 3 weeks for a planned duration of 1 years. Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS rate
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
Measured: From date of randomisation up to approximately 5 years
Secondary outcomes (5)
DFS
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment.
Measured: From date of randomisation up to approximately 10 years
3-year OS rate
Defined as the percentage of patients alive at 3 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Measured: From date of randomization up to approximately 5 years
5-year OS rate
Defined as the percentage of patients alive at 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Measured: From date of randomization up to approximately 5 years
OS
OS is defined as the time from the date of randomisation until death due to any cause.
Measured: From date of randomization up to approximately 10 years
Safety and tolerability in overall population
AEs graded by CTCAE version 5.0
Measured: From date of randomisation up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start20 Mar 2024
- Primary completion20 Mar 2026 (estimated)
- Study completion20 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Yue, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221670
- Sponsor's protocol ID
- NSCLC-Toripalimab-001
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Toripalimab Adjuvant Therapy in High-risk Stage IA2-IB NSCLC With no Driver Alterations (EGFR or ALK) After Complete Resection: a Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06221670
- Acronym / sponsor ID
- NSCLC-Toripalimab-001
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 Mar 2031 (estimated)
- First posted
- 24 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 prospective, open, single-center, single-arm phase II clinical study in non-small cell lung cancer (NSCLC) without common EGFR-sensitive mutations (Ex19del and L858R) or ALK fusion variants identified in the central laboratory. To evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab adjuvant therapy group | Experimental | Drug: ToripalimabPatients must be enrolled within 8 weeks of complete surgical excision and receive Toripalimab at a dose of 240 mg intravenously (IV) once every 3 weeks for a planned duration of 1 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subjects will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
- Male and female, ≥18 years old;
- Primary non-squamous NSCLC confirmed histologically by the central laboratory;
- The subject was clinically confirmed as stage IA2-IB by imaging with tumor lesion size > 2 cm;
- As confirmed by the central laboratory, the tumor contains no common EGFR mutations and ALK fusion variants;
Key exclusion criteria (9 listed)
- Exposure to other antitumor therapies before enrollment;
- Patients who only received segmental resection and wedge resection;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids;
- Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;
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 |
|---|---|---|
| ToripalimabThis is a prospective, open, single-center, single-arm phase II clinical study with no driver mutations identified in the central laboratory，to evaluate the efficacy and safety of adjuvant Toripalimab therapy in completely resected stage IA2-IB non-squamous NSCLC with high-risk factors. | Drug | Toripalimab adjuvant therapy group |
Primary outcome
3-year DFS rate
Time frame: From date of randomisation up to approximately 5 years
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
5 secondary outcomes
DFS
Time frame: From date of randomisation up to approximately 10 years
3-year OS rate
Time frame: From date of randomization up to approximately 5 years
5-year OS rate
Time frame: From date of randomization up to approximately 5 years
OS
Time frame: From date of randomization up to approximately 10 years
Safety and tolerability in overall population
Time frame: From date of randomisation up to approximately 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Dongsheng Yue principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab in people with NSCLC, run by Tianjin Medical University Cancer Institute and 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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongsheng Yue (+8602223109106, yuedongsheng_cg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS rate (time frame: From date of randomisation up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2025.