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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etoposide, Platinum, Toripalimab.
- Who it may be relevant to
- Registry conditions: Postoperative Incidental Small Cell Lung Cancer, Toripalimab Adjuvant Therapy Evaluation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Etoposide
Specified dose on specified days. - Drug Platinum
Specified dose on specified days. - Drug Toripalimab
Specified dose on specified days.
Primary outcome measures
- Disease-Free Survival (DFS) [Time frame: up to 60 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Pulmonary Hospital — Shanghai
Identifiers
NCT: NCT07097948 · LungMate-033