OncoMatch/Clinical Trials/NCT06095583
Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
Is NCT06095583 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Tifcemalimab and toripalimab for limited-stage small cell lung cancer (ls-sclc).
Treatment: Tifcemalimab · toripalimab — The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage III, TNM STAGE I, TNM STAGE II (VALSG, AJCC 8th edition)
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, cisplatin, etoposide) — concurrent chemoradiotherapy
4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide
Must have received: radiation therapy — concurrent chemoradiotherapy
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
Cannot have received: sequential chemoradiotherapy
Received sequential chemoradiotherapy for LS-SCLC
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Goodyear, Arizona
- Banner University Medical Center · Tucson, Arizona
- Genesis Cancer and Blood Institute (Hot Springs, AR) · Hot Springs, Arkansas
- SCRI Nashville · Davis, California
- Zangmeister Cancer Center (Columbus, OH) · Los Angeles, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06095583 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior sequential chemoradiotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or TNM STAGE I or TNM STAGE II is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages