Combination therapy for limited-stage small cell lung cancer

Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Single-arm, Phase 2 Trial

This study is testing a new combination of immunotherapy and chemotherapy to see if it can help people with limited-stage small cell lung cancer have better treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Drugs / interventions: toripalimab, chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06256237 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a new treatment regimen combining the PD-1 antibody toripalimab and the BTLA-targeting antibody JS004 with etoposide and platinum chemotherapy for patients with limited-stage small cell lung cancer (SCLC). The goal is to improve the rate of complete pathological response (CPR) in patients who typically do not achieve this with standard treatments. Participants will receive the combination therapy followed by surgery, and their responses will be closely monitored. The study aims to provide a novel immunotherapeutic strategy to enhance treatment outcomes for SCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of limited-stage small cell lung cancer and good overall health.

Not a fit: Patients with extensive-stage small cell lung cancer or those with significant comorbidities that affect their ability to tolerate surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the chances of achieving a complete pathological response in patients with limited-stage small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating solid tumors, suggesting potential for success in this approach.

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, and limited stage confirmed by imageological examinations (CT, PET-CT or EBUS).
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. Without systematic metastasis (including M1a, M1b and M1c);
9. Expected to be completely resected
10. Patients with lung function can tolerate surgery
11. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
12. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).

Exclusion Criteria:

1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
2. Patients with a malignancy other than SCLC within five years prior to the start of this trial;
3. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
5. Participants who are allergic to the test drug or any auxiliary materials;
6. Participants with Interstitial lung disease currently;
7. Participants with active hepatitis B, hepatitis C or HIV;
8. Pregnant or lactating women;
9. Any malabsorption;
10. Participants suffering from nervous system diseases or mental diseases that cannot cooperate
11. Other factors that researchers think it is not suitable for enrollment.

Where this trial is running

Shanghai

• Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Peng Zhang, PhD

Conditions Limited Stage Small Cell Lung Cancer; small cell lung cancer; Toripalimab; JS004; Limited Stage