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Using toripalimab alone or with tifcemalimab for treating limited-stage small cell lung cancer

A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy

PHASE3 · Shanghai Junshi Bioscience Co., Ltd. · NCT06095583

This study is testing if a new combination of two drugs can help people with limited-stage small cell lung cancer feel better after their initial treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment756 (estimated)
Ages18 Years and up
SexAll
SponsorShanghai Junshi Bioscience Co., Ltd. (other)
Drugs / interventionschemotherapy, radiation, toripalimab, tifcemalimab
Locations156 sites (Goodyear, Arizona and 155 other locations)
Trial IDNCT06095583 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the safety and efficacy of toripalimab, a PD-1 inhibitor, alone or in combination with tifcemalimab, a BTLA inhibitor, as consolidation therapy for patients with limited-stage small cell lung cancer who have not experienced disease progression after chemoradiotherapy. The study is randomized, double-blind, and placebo-controlled, involving multiple regions to ensure diverse patient representation. Participants will receive either the investigational drugs or a placebo, with the aim of determining the most effective treatment approach for this challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed limited-stage small cell lung cancer who have responded to prior chemoradiotherapy.

Not a fit: Patients with advanced-stage small cell lung cancer or those who have not responded to initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with limited-stage small cell lung cancer by enhancing disease control after initial therapy.

How similar studies have performed: While the combination of toripalimab and tifcemalimab is investigational in this context, similar immunotherapy approaches have shown promise in other cancer types, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be enrolled:

1. Male or female with age ≥ 18 years old at the time of informed consent.
2. Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery.
3. Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy.
4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
6. Adequate organ function
7. Female patients of childbearing potential and male patients whose partners are women of childbearing age.
8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria.

1. Mixed SCLC and non-small cell lung cancer (NSCLC).
2. Received sequential chemoradiotherapy for LS-SCLC.
3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe.
4. Patients with active autoimmune disease, history of autoimmune disease.
5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
7. The presence of active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method).
8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate \> 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer.
9. Women who are pregnant or breastfeeding.

Where this trial is running

Goodyear, Arizona and 155 other locations

+106 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Limited-stage Small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.