← Back to Search

Chemotherapy

Ociperlimab + Tislelizumab + Chemotherapy for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only patients who have evaluable PD-L1 results are eligible
Must not have
Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC
Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 months
Awards & highlights

Summary

This trial is testing a new cancer treatment combo vs. the current standard of care to see if the new combo is more effective and has fewer side effects.

Who is the study for?
This trial is for adults with untreated advanced or metastatic non-small cell lung cancer (NSCLC) who have at least one measurable lesion, are in good physical condition (ECOG ≤ 1), and haven't had prior systemic therapy for their condition. They must not have certain gene mutations like ALK, BRAF V600E, EGFR, or ROS1 and can't be on significant immunosuppressive medications.
What is being tested?
The study compares the effectiveness of Ociperlimab combined with Tislelizumab and chemotherapy against just Tislelizumab with chemotherapy in patients. It's a randomized trial where participants don't know which treatment they're getting but the sponsor does.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, potential blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can carry out all my self-care but cannot do heavy physical work.
Select...
My cancer's PD-L1 levels have been tested.
Select...
My lung cancer cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had treatments targeting immune system pathways for my lung cancer.
Select...
I have previously been treated with drugs targeting specific cancer genes.
Select...
My lung cancer does not have EGFR-sensitizing mutations.
Select...
My cancer has the BRAF V600E mutation.
Select...
My cancer is driven by an ALK gene mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 30 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 Investigators
Secondary outcome measures
Duration of Response (DoR) As Assessed by Investigators
Number of Participants Experiencing Adverse Events (AEs)
Overall Response Rate (ORR) as Assessed by Investigators
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A: Ociperlimab + tislelizumab histology-based chemotherapyExperimental Treatment3 Interventions
Group II: Arm B: Placebo + tislelizumab + histology-based chemotherapyPlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ociperlimab
2021
Completed Phase 2
~530
Tislelizumab
2018
Completed Phase 3
~4260

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
178 Previous Clinical Trials
28,648 Total Patients Enrolled

Media Library

Lung Cancer Research Study Groups: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy, Arm B: Placebo + tislelizumab + histology-based chemotherapy
Lung Cancer Clinical Trial 2023: Histology-based Chemotherapy Highlights & Side Effects. Trial Name: NCT05014815 — Phase 2
Histology-based Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014815 — Phase 2
~0 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top