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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 30 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I can carry out all my self-care but cannot do heavy physical work.
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My cancer's PD-L1 levels have been tested.
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I haven't had systemic therapy for my advanced lung cancer but may have had treatment for early-stage cancer over 6 months ago.
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My lung cancer cannot be cured with surgery or radiation.

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
Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs).
Number of Participants Experiencing Adverse Events (AEs)
+3 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
~400
Tislelizumab
2018
Completed Phase 3
~4270

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
173 Previous Clinical Trials
27,734 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

Frequently Asked Questions

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

Is this investigation into a new treatment protocol pioneering?

"Currently, 105 medical trials are ongoing for Ociperlimab across 426 cities and 45 countries. The initial trial of the drug began in 2017 under the sponsorship of BeiGene with 805 participants who successfully completed Phase 3 clinical testing. Since then, a total of 18337 studies have been concluded."

Answered by AI

How many participants are being recruited for this clinical trial?

"According to the trial's parameters, 270 qualified patients are needed. Potential participants can join from Comprehensive Cancer Center of Nevada in Henderson, Nevada or Texas Oncology (Tyler) - USOR in Tyler, Texas."

Answered by AI

Has the Food and Drug Administration granted sanction to Ociperlimab?

"Ociperlimab's safety has been tested, but there is still no evidence of efficacy; thus our team at Power rated its safety a 2 on the 1-3 scale."

Answered by AI

How many locations within the state are conducting this clinical investigation?

"This trial is currently being conducted at 10 sites, with locations in Henderson, Tyler and Los Angeles among others. To reduce travel inconveniences, it may be best to select a site that is closest to you if participating."

Answered by AI

Are new participants being welcomed into the experiment?

"Currently, the clinical trial is in search of participants. It was first announced on November 16th 2021 and had its latest update on September 13th 2022."

Answered by AI

Have there been any precedential experiments with Ociperlimab?

"Ociperlimab was initially studied in 2017 at Uniwersyteckie Centrum Kliniczne, and since then 18337 trials have been concluded. Currently 105 clinical tests are being conducted, the majority of which take place within Henderson, Nevada."

Answered by AI
~26 spots leftby Jul 2024