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

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medicine called toripalimab to chemotherapy can help patients who unexpectedly find out they have a type of lung cancer called small cell lung cancer (SCLC) after having surgery to remove lung cancer. SCLC is a fast-growing cancer that often comes back after treatment. Right now, the usual follow-up treatments don’t work very well for patients whose SCLC is discovered only after surgery. This study wants to see if toripalimab, which helps the immune system fight cancer, can lower the chance of the cancer coming back and help people live longer.

People who might join this trial are adults who have had surgery to remove lung cancer and were then told by the lab tests that they have SCLC. They should be generally healthy enough to participate, with good organ function and a good performance status (meaning they are active and able to take care of themselves). Women who can have children and men will need to use birth control during the study. Participants will receive toripalimab along with chemotherapy after surgery and will be monitored closely to see how well the treatment works and if there are any side effects. This trial is not yet open for enrollment but aims to find better treatment options for this specific group of lung cancer patients.

Gender

ALL

Eligibility criteria

• 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.