Stage IB-IIIB NSCLCPhase 2NCT07039656
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
A Phase 2 study testing Toripalimab and Cisplatin-based chemotherapy in people with Stage IB-IIIB NSCLC and Stage IIB-III NSCLC, run by Wen-zhao ZHONG at 1 site in China.
Trial summary
This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IB-IIIB NSCLC, Stage IIB-III NSCLC
- What is being tested?
- Toripalimab and Cisplatin-based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Patient with age ≥ 18 and ≤75 years old, gender is not limited.
- Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)
- Participants must have had complete resection of NSCLC 60 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate organ function performed within 10 days of treatment initiation
- Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, IUDs, etc., during the study period and for the last 6 months of study drug use. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilised (e.g. hysterectomy, bilateral adnexectomy or radiation ovarian irradiation).
Who cannot join
- Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
- Treatment with prior systemic chemotherapy at any time
- Confirmed EGFR or ALK mutations
- Patient has a history of active autoimmune disease or autoimmune disease that may recur
- Active hepatitis B and C patients will need to be on relevant antiviral therapy, have HBV-DNA <2000 IU/ml (<104 copies/ml) and have received anti-HBV therapy for at least 14 days prior to study participation, and continue therapy for the duration of the treatment period; HCV RNA-positive patients must be on antiviral therapy and have a liver function that is within the elevated CTCAE grade 1;
- Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;
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- History of allergy to monoclonal antibody drugs
- Patients with previous allogeneic stem cell or parenchymal organ transplantation
- Having a mental illness or any other condition that renders treatment non-compliant
- Patients unable or unwilling to sign the informed consent form
- The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.
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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wen-Zhao Zhong, MD, 86-15920473691, 13609777314@163.com
Wen-Zhao Zhong
About this study
Official title: Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial
This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).
Researchers will compare outcomes between two cohorts:
- Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
- Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
- Conditions
- Stage IB-IIIB NSCLC, Stage IIB-III NSCLC
- Being tested
- Toripalimab, Cisplatin-based chemotherapy
- Keywords
- Toripalimab, MRD, Adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).
Cisplatin-based chemotherapyDrug
Cisplatin[75 mg/m^2 IV Q3W]/carboplatin[AUC 5 IV Q3W]+paclitaxel[260 mg/m^2 IV Q3W] or cisplatin[75 mg/m^2 IV Q3W)]/carboplatin[AUC 5 IV Q3W]+ pemetrexed[500 mg/m2 IV Q3W],dependent on tumor histology. Participants will receive Chemotherapy for 3-4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Stage IB-IIIB participants following completely resection without neoadjuvant therapy | Experimental | Not described Receives: Drug: Toripalimab; Drug: Cisplatin-based chemotherapy |
| Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy | Experimental | Not described Receives: Drug: Toripalimab; Drug: Cisplatin-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-Free Survival
DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Measured: 24 months
Secondary outcomes (2)
Overall Survival
OS was defined as the time from the start of treatment to the date of death.
Measured: 60 months
Adverse events
Incidence of AE/SAE which has been confirmed correlation with treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB-IIIB NSCLCStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039656
- Sponsor's protocol ID
- KY2024-1057-03
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Treatment and survival data for participants will be presented in the corresponding manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial
- ClinicalTrials.gov ID
- NCT07039656
- Acronym / sponsor ID
- KY2024-1057-03
- Conditions
- Stage IB-IIIB NSCLC, Stage IIB-III NSCLC
- Keywords
- Toripalimab, MRD, Adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- Wen-zhao ZHONGUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jun 2025 (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 two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).
Researchers will compare outcomes between two cohorts:
- Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;
- Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage IB-IIIB participants following completely resection without neoadjuvant therapy | Experimental | Drug: Toripalimab, Drug: Cisplatin-based chemotherapy |
| Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy | Experimental | Drug: Toripalimab, Drug: Cisplatin-based chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form
- Patient with age ≥ 18 and ≤75 years old, gender is not limited.
- Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)
- Participants must have had complete resection of NSCLC 60 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Key exclusion criteria (11 listed)
- Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;
- Treatment with prior systemic chemotherapy at any time
- Confirmed EGFR or ALK mutations
- Patient has a history of active autoimmune disease or autoimmune disease that may recur
- Active hepatitis B and C patients will need to be on relevant antiviral therapy, have HBV-DNA <2000 IU/ml (<104 copies/ml) and have received anti-HBV therapy for at least 14 days prior to study participation, and continue therapy for the duration of the treatment period; HCV RNA-positive patients must be on antiviral therapy and have a liver function that is within the elevated CTCAE grade 1;
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 |
|---|---|---|
| ToripalimabParticipants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days). | Drug | Stage IB-IIIB participants following completely resection without neoadjuvant therapy, Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy |
| Cisplatin-based chemotherapyCisplatin[75 mg/m^2 IV Q3W]/carboplatin[AUC 5 IV Q3W]+paclitaxel[260 mg/m^2 IV Q3W] or cisplatin[75 mg/m^2 IV Q3W)]/carboplatin[AUC 5 IV Q3W]+ pemetrexed[500 mg/m2 IV Q3W],dependent on tumor histology. Participants will receive Chemotherapy for 3-4 cycles | Drug | Stage IB-IIIB participants following completely resection without neoadjuvant therapy, Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy |
Primary outcome
2-year Disease-Free Survival
Time frame: 24 months
DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
2 secondary outcomes
Overall Survival
Time frame: 60 months
Adverse events
Time frame: 24 months
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 7 Aug 2025.
- Individual participant dataSharing planned: No. Treatment and survival data for participants will be presented in the corresponding manuscript.
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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.
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 and Cisplatin-based chemotherapy in people with Stage IB-IIIB NSCLC and Stage IIB-III NSCLC, run by Wen-zhao ZHONG 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 7 inclusion and 11 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 7 Aug 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 Wen-Zhao Zhong, MD (86-13609777314, 13609777314@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease-Free Survival (time frame: 24 months). 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 7 Aug 2025.