Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer

Launched by SHANGHAI PULMONARY HOSPITAL, SHANGHAI, CHINA · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with extensive-stage small cell lung cancer (SCLC) who have either relapsed or progressed after initial treatment. The trial will test a combination of two immunotherapy drugs, toripalimab and JS004, along with standard platinum-based chemotherapy. The goal is to see if this new combination can help improve the effectiveness of treatment and offer better outcomes for patients whose cancer has returned or worsened.

To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of extensive-stage or recurrent SCLC. They should be in relatively good health, with a life expectancy of at least 12 weeks, and have no other serious health issues that could interfere with the study. Participants will be closely monitored throughout the trial to assess the safety and effectiveness of the treatment. This trial is currently not recruiting, but it aims to provide valuable insights into new treatment options for a challenging condition.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. The patient shall sign the Informed Consent Form;
• • 2. Aged 18 ≥ years;
• • 3. Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
• • 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
• • 5. Life expectancy is at least 12 weeks;
• • 6. At least 1 measurable lesion according to RECIST 1.1;
• • 7. Patients with good function of other main organs (liver, kidney, blood system, etc.);
• • 8. Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
• • 9. Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.
• 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.