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Monoclonal Antibodies

Pembrolizumab/Vibostolimab + Docetaxel for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days prior to randomization

Has PD as determined by the investigator after platinum doublet chemotherapy for metastatic disease

Must not have

Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

Has received previous treatment with another agent targeting the T-cell immunoreceptor with immunoglobulin [Ig] and immunoreceptor tyrosine-based inhibitory motif [ITIM] pathway

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 21 months

Summary

This trial is testing a new cancer treatment involving two drugs, pembrolizumab and vibostolimab, given together or separately. The trial will compare these drugs to a placebo (fake drug) plus a standard cancer drug, docetaxel. The trial is testing whether the new treatment is better than the standard treatment at slowing or stopping cancer growth.

Who is the study for?

This trial is for adults with metastatic non-small cell lung cancer (NSCLC) who have seen their disease progress after platinum chemotherapy and anti-PD-1/PD-L1 therapy. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and have no severe allergies to the drugs being tested or significant health issues like active infections or autoimmune diseases.

What is being tested?

The study tests a combination of pembrolizumab/vibostolimab with docetaxel against docetaxel alone in patients whose NSCLC has worsened despite previous treatments. The goal is to see if adding pembrolizumab/vibostolimab can improve survival without the cancer getting worse compared to just using docetaxel.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting various organs, infusion-related reactions from the drug entering your body, fatigue, blood disorders that may affect how your blood clots or fights infection, and potential harm to an unborn baby if pregnancy occurs during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer progressed after platinum-based chemotherapy for metastatic disease.

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My lung cancer diagnosis is confirmed and it has spread.

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I have at least one tumor that can be measured on a CT or MRI scan.

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I have given a sample of my tumor for PD-L1 testing.

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My cancer is not suitable for EGFR, ALK, or ROS1 targeted therapy.

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My cancer has worsened despite treatment with a PD-1/PD-L1 inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active or untreated brain metastases or cancer in my spinal fluid.

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I have been treated with drugs targeting the immune system's T-cells before.

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I have a known history of HIV, Hepatitis B, or Hepatitis C.

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I am highly allergic to docetaxel or pembrolizumab/vibostolimab.

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I have lung disease or needed steroids for lung inflammation.

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I have been treated for an autoimmune disease in the last 2 years.

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I have received an organ or tissue transplant from another person.

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I have been treated with docetaxel alone or with other therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 21 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) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) Assessment

Secondary study objectives

Duration of Response (DOR) Per RECIST 1.1 by BICR Assessment

Number of Participants Who Discontinued Study Treatment Due to an AE

Number of Participants Who Experienced an Adverse Event (AE)

+2 more

Side effects data

From 2024 Phase 2 trial • 255 Patients • NCT04725188

34%

Diarrhoea

34%

Pruritus

32%

Anaemia

29%

Asthenia

28%

Alopecia

27%

Fatigue

27%

Nausea

24%

Constipation

24%

Rash

21%

Decreased appetite

21%

Dyspnoea

18%

Oedema peripheral

16%

Stomatitis

16%

Neutrophil count decreased

15%

Neuropathy peripheral

15%

Cough

14%

Vomiting

14%

COVID-19

14%

Arthralgia

14%

Dysgeusia

13%

Weight decreased

Insomnia

Pyrexia

Myalgia

Eczema

Nail disorder

Lacrimation increased

Mucosal inflammation

Pneumonia

Hyperglycaemia

Hypokalaemia

Dry skin

Hypothyroidism

Blood creatinine increased

Hypomagnesaemia

Pain in extremity

Hypertension

Abdominal pain

Paraesthesia

Palmar-plantar erythrodysaesthesia syndrome

Septic shock

Haemoptysis

Febrile neutropenia

Gastritis

Cardiac failure

Hip fracture

Dehydration

Interstitial lung disease

Drug eruption

Amylase increased

Pneumonitis

Atrial fibrillation

Immune-mediated enterocolitis

Neutropenic sepsis

Humerus fracture

Chest pain

Hypophysitis

Pericardial effusion

Retinal detachment

Intestinal haemorrhage

Performance status decreased

Hypersensitivity

Gastrointestinal disorder

General physical health deterioration

Enterococcal infection

Gastroenteritis

Herpes zoster

Death

Abdominal sepsis

Cellulitis

Cystitis

Device related bacteraemia

Large intestine infection

Oral candidiasis

Hypophagia

Osteoporotic fracture

Pathological fracture

Cerebrovascular accident

Epilepsy

Hyperaesthesia

Lethargy

Peripheral sensorimotor neuropathy

Polyneuropathy

Acute pulmonary oedema

Acute respiratory distress syndrome

Acute respiratory failure

Chronic obstructive pulmonary disease

Immune-mediated lung disease

Respiratory failure

Dermatitis

Lichenification

Rash morbilliform

Skin toxicity

Euthanasia

Hypotension

Hypovolaemic shock

Superior vena cava occlusion

Lipase increased

Nail toxicity

100%

80%

60%

40%

20%

Study treatment Arm

Arm 3: Placebo + Docetaxel

Arm 1: Pembrolizumab/Vibostolimab Coformulation + Docetaxel

Arm 2: Pembrolizumab/Vibostolimab Coformulation

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2: Pembrolizumab/Vibostolimab coformulationExperimental Treatment1 Intervention

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W for up to 35 cycles up to approximately 2 years. Each cycle will be 21 days.

Group II: Arm 1: Pembrolizumab/Vibostolimab coformulation + DocetaxelExperimental Treatment2 Interventions

Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 via IV infusion Q3W. Each cycle will be 21 days.

Group III: Arm 3: Placebo + DocetaxelActive Control2 Interventions

Participants receive normal saline placebo via IV infusion Q3W for up to 35 cycles up to approximately 2 years plus docetaxel 75 mg/m\^2 IV infusion Q3W. Each cycle will be 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab/Vibostolimab coformuation

2021

Completed Phase 2

~260

Docetaxel

1995

Completed Phase 4

~6550