Postoperative Incidental Small Cell Lung CancerPhase 2AdjuvantNCT07097948
Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study Protocol Number: LungMate-033
A Phase 2 study testing Etoposide, Platinum and Toripalimab in people with Postoperative Incidental Small Cell Lung Cancer and Toripalimab Adjuvant Therapy Evaluation, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Small cell lung cancer (SCLC) is highly malignant and aggressive, with most patients presenting with metastases at diagnosis. For postoperatively incidentally detected SCLC (identified unexpectedly in pathological examinations after surgery), conventional adjuvant chemoradiotherapy has shown limited efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Incidental Small Cell Lung Cancer, Toripalimab Adjuvant Therapy Evaluation
- What is being tested?
- Etoposide, Platinum and Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient shall sign the Informed Consent Form;
- Aged ≥ 18 years;
- Patients with definitely incidental SCLC confirmed by pathological results after radical resection of lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Life expectancy is at least 12 weeks;
- Good function of other major organs (liver, kidney, hematological system, etc.);
- Fertile female patients must undergo a pregnancy test within 7 days before the start of treatment with a negative result; and reliable contraceptive measures (such as intrauterine devices, contraceptives and condoms) should be used during the trial and within 30 days after its completion;
- Fertile male subjects must use condoms for contraception during the trial and within 30 days after its completion.
Who cannot join
- Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- Participants who are allergic to the test drug or any auxiliary materials;
- Participants with active hepatitis B, hepatitis C or HIV;
- Participants with Interstitial lung disease currently;
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- Pregnant or lactating women;
- Any malabsorption;
- Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- Other factors that researchers think it is not suitable for enrollment.
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
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Peng Zhang, PhD, 02165115006, zhangpeng1121@tongji.edu.cn
About this study
Official title: Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study
Small cell lung cancer (SCLC) is highly malignant and aggressive, with most patients presenting with metastases at diagnosis. For postoperatively incidentally detected SCLC (identified unexpectedly in pathological examinations after surgery), conventional adjuvant chemoradiotherapy has shown limited efficacy, characterized by high recurrence rates and suboptimal long-term survival.Notably, advances in immunotherapy have transformed SCLC management. The EXTENTORCH trial, a pivotal study published in JAMA Oncology, demonstrated that toripalimab plus chemotherapy significantly improved outcomes in extensive-stage SCLC (ES-SCLC), achieving a reduced risk of progression or death (HR=0.67, 95% CI 0.54-0.82, P<0.001) with manageable safety, marking a substantial therapeutic breakthrough. Given the proven efficacy of toripalimab in ES-SCLC, there is a strong rationale to extend this strategy to postoperatively incidentally detected SCLC. This trial aims to evaluate the efficacy and safety of toripalimab as adjuvant maintenance therapy in this cohort, with the objective of reducing recurrence and enhancing long-term survival.
- Being tested
- Etoposide, Platinum, Toripalimab
- Keywords
- Small cell lung cancer, Postoperative adjuvant therapy, Toripalimab, Immunological maintenance, Recurrence
- Medical subject headings
- Small Cell Lung Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Specified dose on specified days.
PlatinumDrug
Specified dose on specified days.
ToripalimabDrug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Adjuvant Chemotherapy | Active comparator | In this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks. Receives: Drug: Etoposide; Drug: Platinum |
| Postoperative Chemotherapy Combined with Toripalimab Maintenance | Experimental | In this arm, enrolled subjects will first receive postoperative chemotherapy (4 cycles, 3 weeks per cycle), followed by toripalimab for immunological maintenance therapy, administered once every 3 weeks. Receives: Drug: Etoposide; Drug: Platinum; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Defined as the time from the initiation of treatment to the first confirmed disease recurrence or death from any cause, whichever occurs first.
Measured: up to 60 months
Secondary outcomes (4)
Overall Survival (OS)
Defined as the time from the date of initial treatment to death from any cause. For patients still alive at the time of analysis, the date of last contact will be used as the censoring date. Survival curves will be estimated using the Kaplan-Meier method.
Measured: up to 60 months
Health related quality of life (HRQol)：EORTC-QLQ-C30
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 , Version 3). EORTC's QLQ-C30 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options.
Measured: up to 5 months
Health related quality of life (HRQol)：LC13
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (LC13, Version 3).The items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Measured: up to 5 months
Treatment-related adverse event (TRAE)
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Incidental Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- For patients with postoperatively incidentally detected small cell lung cancer, all enrolled patients will be randomized into two groups: one group receiving toripalimab combined with platinum-based chemotherapy, and the other group receiving platinum-based chemotherapy alone.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097948
- Sponsor's protocol ID
- LungMate-033
- Acronym
- Adjuvant
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Incidental Small Cell Lung Cancer After Radical Resection of Lung Cancer: A Single-Center, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07097948
- Acronym / sponsor ID
- Adjuvant / LungMate-033
- Keywords
- Small cell lung cancer, Postoperative adjuvant therapy, Toripalimab, Immunological maintenance, Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 1 Aug 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.
Small cell lung cancer (SCLC) is highly malignant and aggressive, with most patients presenting with metastases at diagnosis. For postoperatively incidentally detected SCLC (identified unexpectedly in pathological examinations after surgery), conventional adjuvant chemoradiotherapy has shown limited efficacy, characterized by high recurrence rates and suboptimal long-term survival.Notably, advances in immunotherapy have transformed SCLC management. The EXTENTORCH trial, a pivotal study published in JAMA Oncology, demonstrated that toripalimab plus chemotherapy significantly improved outcomes in extensive-stage SCLC (ES-SCLC), achieving a reduced risk of progression or death (HR=0.67, 95% CI 0.54-0.82, P<0.001) with manageable safety, marking a substantial therapeutic breakthrough. Given the proven efficacy of toripalimab in ES-SCLC, there is a strong rationale to extend this strategy to postoperatively incidentally detected SCLC. This trial aims to evaluate the efficacy and safety of toripalimab as adjuvant maintenance therapy in this cohort, with the objective of reducing recurrence and enhancing long-term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For patients with postoperatively incidentally detected small cell lung cancer, all enrolled patients will be randomized into two groups: one group receiving toripalimab combined with platinum-based chemotherapy, and the other group receiving platinum-based chemotherapy alone.
| Arm | Type | Receives |
|---|---|---|
| Postoperative Adjuvant Chemotherapy | Active comparator | Drug: Etoposide, Drug: PlatinumIn this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks. |
| Postoperative Chemotherapy Combined with Toripalimab Maintenance | Experimental | Drug: Etoposide, Drug: Platinum, Drug: ToripalimabIn this arm, enrolled subjects will first receive postoperative chemotherapy (4 cycles, 3 weeks per cycle), followed by toripalimab for immunological maintenance therapy, administered once every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient shall sign the Informed Consent Form;
- Aged ≥ 18 years;
- Patients with definitely incidental SCLC confirmed by pathological results after radical resection of lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Life expectancy is at least 12 weeks;
Key exclusion criteria (10 listed)
- Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- Participants who are allergic to the test drug or any auxiliary materials;
- Participants with active hepatitis B, hepatitis C or HIV;
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 |
|---|---|---|
| EtoposideSpecified dose on specified days. | Drug | Postoperative Adjuvant Chemotherapy, Postoperative Chemotherapy Combined with Toripalimab Maintenance |
| PlatinumSpecified dose on specified days. | Drug | Postoperative Adjuvant Chemotherapy, Postoperative Chemotherapy Combined with Toripalimab Maintenance |
| ToripalimabSpecified dose on specified days. | Drug | Postoperative Chemotherapy Combined with Toripalimab Maintenance |
Primary outcome
Disease-Free Survival (DFS)
Time frame: up to 60 months
Defined as the time from the initiation of treatment to the first confirmed disease recurrence or death from any cause, whichever occurs first.
4 secondary outcomes
Overall Survival (OS)
Time frame: up to 60 months
Health related quality of life (HRQol)：EORTC-QLQ-C30
Time frame: up to 5 months
Health related quality of life (HRQol)：LC13
Time frame: up to 5 months
Treatment-related adverse event (TRAE)
Time frame: Up to 30 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 1 Aug 2025.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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 Etoposide, Platinum and Toripalimab in people with Postoperative Incidental Small Cell Lung Cancer and Toripalimab Adjuvant Therapy Evaluation, run by Shanghai Pulmonary Hospital, Shanghai, China 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 1 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 Peng Zhang, PhD (02165115006, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: up to 60 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 1 Aug 2025.