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New treatment option for Limited-stage Small Cell Lung Cancer (LS-SCLC)
Official title 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)
ClinicalTrials.gov ID: NCT06095583
What this study is testing
What is Tifcemalimab injection?
Tifcemalimab injection is an investigational medicine, being studied as a potential treatment for limited-stage small cell lung cancer (ls-sclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet all of the following to be enrolled:
- Male or female with age ≥ 18 years old at the time of informed consent.
- Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients...
- Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total...
- Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and...
You likely can't join if
- Patients will be excluded from the study if they meet any of the following criteria.
- Mixed SCLC and non-small cell lung cancer (NSCLC).
- Received sequential chemoradiotherapy for LS-SCLC.
- Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or...
- Patients with active autoimmune disease, history of autoimmune disease.
- History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation...
See the full eligibility criteria
- Patients must meet all of the following to be enrolled:
- Male or female with age ≥ 18 years old at the time of informed consent.
- 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...
- 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...
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .
- Adequate organ function
- Female patients of childbearing potential and male patients whose partners are women of childbearing age.
- Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.
- Patients will be excluded from the study if they meet any of the following criteria.
- Mixed SCLC and non-small cell lung cancer (NSCLC).
- Received sequential chemoradiotherapy for LS-SCLC.
- 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...
- Patients with active autoimmune disease, history of autoimmune disease.
- History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
- 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).
- 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...
- Women who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Tucson, Arizona, United States
- Hot Springs, Arkansas, United States
- Davis, California, United States
- Los Angeles, California, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Marietta, Georgia, United States
- Louisville, Kentucky, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Toledo, Ohio, United States
+ 102 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Tucson, Arizona, United States; Hot Springs, Arkansas, United States; Davis, California, United States; Los Angeles, California, United States; Fort Myers, Florida, United States and 116 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.