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Experimental group B 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS)

Progression-free survival (PFS)

Secondary outcome measures

1 year OS rate

1-year OS rate

2 year OS rate

+9 more

Other outcome measures

correlation

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)

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shanghai Junshi Bioscience Co., Ltd.Lead Sponsor

112 Previous Clinical Trials

26,487 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals enrolled in this clinical research study?

"Affirmative. Information from clinicaltrials.gov indicates that this study is actively seeking candidates. The trial was initially listed on November 15th, 2023 and last modified on February 4th, 2024. It aims to enroll a total of 756 participants distributed among 15 different sites."

Answered by AI

Is the enrollment for this medical study currently accepting new participants?

"As per clinicaltrials.gov, the ongoing recruitment of participants for this study commenced on 11/15/2023. The most recent modification to the trial details was made on 2/4/2024."

Answered by AI

What is the level of risk associated with Experimental group B for participants?

"The safety rating for Experimental group B is designated as 3 by our team at Power, reflecting the extensive safety data available due to the Phase 3 nature of this trial and initial evidence supporting effectiveness."

Answered by AI

In how many distinct settings is this research study being conducted?

"The research is being conducted at ICO-Institute of Clinical Oncology-Hospital in Tbilisi, Taipei; Multprofil Clinic Consilium Medulla in Toledo, Liaoning; and Toledo Clinic Cancer Center-Toledo in Taipei city, Heilongjiang. Additionally, there are 15 more sites involved in this study."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The primary focus of this investigation, lasting around 3 years, is Progression-free survival (PFS). Among the secondary objectives are assessing the 2-year OS rate to compare and assess tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC. Additional secondary outcomes include evaluating the duration of response (DoR) by comparing tifcemalimab and toripalimab (Arm A) against placebo (Arm C), along with investigating PFS by comparing toripalimab (Arm B) versus placebo"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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. https://clinicaltrials.gov/ct2/show/NCT06095583.

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