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

NCT07097948 | Not Yet Recruiting Phase 2

• 1 other identifier: LungMate-033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Incidental Small Cell Lung Cancer; Toripalimab Adjuvant Therapy Evaluation

Keywords

Small cell lung cancer; Postoperative adjuvant therapy; Toripalimab; Immunological maintenance; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 60 months

Secondary Outcomes (4)

• Overall Survival (OS)

  up to 60 months

• Health related quality of life (HRQol)：EORTC-QLQ-C30

  up to 5 months

• Health related quality of life (HRQol)：LC13

  up to 5 months

• Treatment-related adverse event (TRAE)

  Up to 30 months

Study Arms (2)

Postoperative Adjuvant Chemotherapy

ACTIVE COMPARATOR

In this arm, enrolled subjects will receive postoperative adjuvant chemotherapy, totaling 4 cycles, with each cycle lasting 3 weeks.

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.

Drug: Etoposide; Drug: Platinum; Drug: Toripalimab

Interventions

Etoposide DRUG

Specified dose on specified days.

Postoperative Adjuvant Chemotherapy; Postoperative Chemotherapy Combined with Toripalimab Maintenance

Platinum DRUG

Specified dose on specified days.

Postoperative Adjuvant Chemotherapy; Postoperative Chemotherapy Combined with Toripalimab Maintenance

Toripalimab DRUG

Specified dose on specified days.

Postoperative Chemotherapy Combined with Toripalimab Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China, 200433, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Recurrence

Interventions

Etoposide; Platinum; toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Peng Zhang, PhD

CONTACT

02165115006; zhangpeng1121@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)