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Chemotherapy

Ociperlimab + Tislelizumab for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 months
Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for non-small cell lung cancer. The primary objectives are to compare progression-free survival and complete response rate between the new treatment and two other standard treatments. The secondary objective is to compare overall survival and progression-free survival in people with a certain protein.

Who is the study for?
This trial is for adults with Stage III unresectable non-small cell lung cancer who've completed at least 2 cycles of platinum-based chemo with radiotherapy and haven't progressed post-treatment. They must have good performance status, adequate organ function, and provide tissue samples. Excluded are those with prior PD-1/PD-L1 pathway treatment, active autoimmune diseases, certain infections or unresolved toxicities from previous treatments.Check my eligibility
What is being tested?
The study compares progression-free survival between two arms: Arm A receives Ociperlimab plus Tislelizumab; Arm C gets Durvalumab after concurrent chemoradiotherapy. The goal is to see which combination works better in preventing the cancer from progressing.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, possible digestive issues and an increased risk of infection due to immune system suppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Secondary outcome measures
Duration of Response (DOR)
Evaluate PD-L1 and TIGIT expression in archival and/or fresh tumor tissues
Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
+11 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: durvalumabExperimental Treatment1 Intervention
durvalumab every 2 weeks or 4 weeks
Group II: Arm B: tislelizumabExperimental Treatment1 Intervention
tislelizumab every 3 weeks
Group III: Arm A: ociperlimab + tislelizumabExperimental Treatment2 Interventions
ociperlimab combined with tislelizumab every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tislelizumab
Not yet FDA approved
Ociperlimab
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,751 Total Patients Enrolled
Yalan Yang, MDStudy DirectorBeiGene

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04866017 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A: ociperlimab + tislelizumab, Arm B: tislelizumab, Arm C: durvalumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT04866017 — Phase 3
Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04866017 — Phase 3

Frequently Asked Questions

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

Are there still positions available in this trial for volunteers?

"From what is displayed on clinicaltrials.gov, this study is looking for more participants and is still open. The original posting date was 6/17/2021, with the most recent edit on 10/21/2021."

Answered by AI

What is the status of Durvalumab's FDA approval process?

"Given that this is a Phase 3 trial with supporting efficacy data and multiple rounds of safety data, Durvalumab received a score of 3 for safety."

Answered by AI

For what common illnesses is Durvalumab prescribed?

"Durvalumab is a medication used to treat non-small cell lung cancer that has spread and is unable to be removed by surgery. Additionally, it can be given to patients who have not yet received treatment for metastatic ureter urothelial carcinoma or those with advance directives."

Answered by AI

How many individuals are being asked to participate in this research?

"Indeed, the information available on clinicaltrials.gov affirms that this study is still recruiting patients. Originally posted on June 17th, 2021, with the most recent update on October 21st, 2021, this trial is looking for 900 individuals at a single location."

Answered by AI

Is Durvalumab a new or novel drug?

"There are a total of 444 studies underway that involve Durvalumab. Of these, 69 are in the critical third stage. Trials for this medication are primarily based in Nanning, Guangxi but there are 15240 hospitals and research centres that are running trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
2021. "A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04866017.
~16 spots leftby Apr 2025
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