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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
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

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
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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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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:
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I have not had treatments targeting immune system pathways for my lung cancer.
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I have previously been treated with drugs targeting specific cancer genes.
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My lung cancer does not have EGFR-sensitizing mutations.
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My cancer has the BRAF V600E mutation.
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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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS) as Assessed by Investigators
Secondary study objectives
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

Side effects data

From 2023 Phase 2 trial • 126 Patients • NCT04952597
90%
Anaemia
83%
Nausea
78%
White blood cell count decreased
71%
Alopecia
68%
Neutrophil count decreased
63%
Platelet count decreased
59%
Constipation
54%
Vomiting
51%
Decreased appetite
41%
Radiation oesophagitis
39%
Rash
39%
Hyponatraemia
29%
Hypoalbuminaemia
29%
Cough
27%
Lymphocyte count decreased
22%
Asthenia
22%
Aspartate aminotransferase increased
22%
Hypokalaemia
20%
Pyrexia
20%
Alanine aminotransferase increased
20%
Weight decreased
17%
Fatigue
17%
Productive cough
15%
Diarrhoea
15%
Hyperglycaemia
15%
Blood bilirubin increased
15%
Pneumonia
12%
Malaise
12%
Hypothyroidism
12%
Arthralgia
12%
Insomnia
12%
Haemoptysis
12%
Eczema
10%
Dysphagia
10%
Abdominal pain upper
10%
Pneumonitis
10%
Dyspepsia
10%
Abdominal distension
10%
Hypertriglyceridaemia
10%
Hypoproteinaemia
10%
Dizziness
7%
Chest pain
7%
Abdominal pain
7%
Gamma-glutamyltransferase increased
7%
Pruritus
7%
Hypochloraemia
7%
Thrombocytopenia
7%
Non-cardiac chest pain
7%
Upper respiratory tract infection
7%
Fibrin D dimer increased
7%
Hypomagnesaemia
7%
Radiation pneumonitis
5%
Blood creatinine increased
5%
Dyspnoea
5%
Intervertebral disc protrusion
5%
Hiccups
5%
Gastritis
5%
Toothache
5%
Leukopenia
5%
Back pain
5%
Oedema peripheral
5%
Blood creatine phosphokinase increased
5%
Hyperuricaemia
5%
Hypocalcaemia
5%
Malnutrition
5%
Radiation skin injury
5%
Pain in extremity
5%
Neutropenia
5%
Influenza
5%
Laryngeal pain
2%
Immune-mediated lung disease
2%
Hypotension
2%
Oropharyngeal pain
2%
Blood fibrinogen increased
2%
Oesophageal perforation
2%
Upper gastrointestinal haemorrhage
2%
Septic shock
2%
Hypertension
2%
C-reactive protein increased
2%
Hypercholesterolaemia
2%
Blood urea increased
2%
Immune-mediated enterocolitis
2%
Pneumonia bacterial
2%
Ataxia
2%
Myocardial necrosis marker increased
2%
COVID-19 pneumonia
2%
Interstitial lung disease
2%
Sinusitis
2%
Gastrooesophageal reflux disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ociperlimab + Tislelizumab
Arm C: Concurrent Chemoradiotherapy (cCRT)
Arm B: Tislelizumab

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
histology-based chemotherapy
2021
Completed Phase 2
~280
Ociperlimab
2021
Completed Phase 2
~1300
Tislelizumab
2018
Completed Phase 3
~4560

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
200 Previous Clinical Trials
31,373 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy, Arm B: Placebo + tislelizumab + histology-based chemotherapy
Non-Small Cell 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
~67 spots leftby Jan 2026
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