Postoperative Incidental Small Cell Lung Cancer, Toripalimab Adjuvant Therapy Evaluation
Conditions
Keywords
Small cell lung cancer, Postoperative adjuvant therapy, Toripalimab, Immunological maintenance, Recurrence
Brief 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, 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
DRUGEtoposide
Specified dose on specified days.
DRUGPlatinum
Specified dose on specified days.
DRUGToripalimab
Specified dose on specified days.
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient shall sign the Informed Consent Form; 2. Aged ≥ 18 years; 3. Patients with definitely incidental SCLC confirmed by pathological results after radical resection of lung cancer; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Life expectancy is at least 12 weeks; 6. Good function of other major organs (liver, kidney, hematological system, etc.); 7. 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; 8. Fertile male subjects must use condoms for contraception during the trial and within 30 days after its completion.
Exclusion criteria
1. Patients with a malignancy other than SCLC within five years prior to the start of this trial; 2. Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.); 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with active hepatitis B, hepatitis C or HIV; 6. Participants with Interstitial lung disease currently; 7. Pregnant or lactating women; 8. Any malabsorption; 9. Participants suffering from nervous system diseases or mental diseases that cannot cooperate; 10. Other factors that researchers think it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 60 months | 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. |
| Health related quality of life (HRQol)：EORTC-QLQ-C30 | up to 5 months | 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. |
| Health related quality of life (HRQol)：LC13 | up to 5 months | 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. |
| Treatment-related adverse event (TRAE) | Up to 30 months | TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants. |
Countries
China
Contacts
Primary ContactPeng Zhang, PhD
Outcome results
None listed