NCT07097948Not yet recruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Diseases
- Lung cancer
- NCT number
- NCT07097948
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Aug 2025 to the primary completion date, 31 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a malignancy other than SCLC within five years prior to the start of this trial;
Other illness
- 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;
- Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
Other
- Pregnant or lactating women;
- Any malabsorption;
- Other factors that researchers think it is not suitable for enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.