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Toripalimab + Tifcemalimab for Small Cell Lung Cancer

Phase 3
Recruiting
Research Sponsored by Shanghai Junshi Bioscience Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received CRT defined as 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide, 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, and must begin investigational interventions within 42 days of the last dose of chemotherapy
Male or female with age ≥ 18 years old at the time of informed consent
Must not have
Mixed SCLC and non-small cell lung cancer (NSCLC)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3years
Awards & highlights
Pivotal Trial

Summary

This trial is testing the safety and effectiveness of using two drugs, toripalimab and tifcemalimab, either alone or together, as a follow-up treatment for patients with limited

Who is the study for?
This trial is for adults over 18 with limited-stage small cell lung cancer (LS-SCLC) who've completed chemoradiotherapy without disease progression. They should have responded well to initial treatment, be in good physical condition, and have proper organ function. Women of childbearing age and men with partners of childbearing potential must agree to contraception.
What is being tested?
The study tests the safety and effectiveness of toripalimab alone or combined with tifcemalimab as additional therapy post-chemoradiotherapy in LS-SCLC patients. Both drugs are monoclonal antibodies; one targets PD-1 and the other BTLA, but neither is yet approved for this cancer type.
What are the potential side effects?
As both toripalimab and tifcemalimab are monoclonal antibodies, potential side effects may include allergic reactions at the injection site, fatigue, fever, chills, body aches or pains similar to flu symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've completed a specific chemotherapy and radiotherapy regimen and can start the trial within 42 days after my last chemo dose.
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I am 18 years old or older.
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My small cell lung cancer diagnosis is confirmed by lab tests.
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My cancer has not worsened after receiving platinum-based treatment.
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I am fully active or can carry out light work.
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I am of childbearing age or my partner is.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung cancer is a mix of small cell and non-small cell types.
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I have recovered from previous cancer treatment side effects, except for hair loss.
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I have a history of immunodeficiency, such as HIV, or have had an organ or bone marrow transplant.
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I am not pregnant or breastfeeding.
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I received step-by-step chemo and radiation for limited-stage small cell lung cancer.
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I have never had lung inflammation or scarring, except for mild radiation effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS
Overall survival (OS)
Progression-free survival (PFS)
Secondary study objectives
1 year OS rate
1-year OS rate
2 year OS rate
+9 more
Other study objectives
correlation

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental group BExperimental Treatment2 Interventions
Placebo for tifcemalimab (IV) and toripalimab (240 mg IV)
Group II: Experimental group AExperimental Treatment2 Interventions
Tifcemalimab (200 mg intravenous infusion \[IV\]) and toripalimab (240 mg IV)
Group III: Placebo group CPlacebo Group2 Interventions
Placebos for both tifcemalimab and toripalimab (IV)

Find a Location

Who is running the clinical trial?

Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor
114 Previous Clinical Trials
27,012 Total Patients Enrolled
~504 spots leftby Jul 2027
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