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Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

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

Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy

Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC

Must not have

Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients

Has a diagnosis of small cell lung cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at designated time points up to approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of pembrolizumab with different chemotherapies and/or other immunotherapy drugs to see if it is more effective and has fewer side effects than other treatments for people with squamous or non-squamous NSCLC.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had treatment before. They should not be eligible for approved targeted therapies, have good organ function, and agree to use contraception. Pregnant or breastfeeding individuals, those with certain heart conditions, active infections, recent major surgery or live vaccines are excluded.

What is being tested?

The study tests the effectiveness and safety of pembrolizumab combined with chemotherapy plus one of four investigational agents (vibostolimab, boserolimab, MK-4830, or MK-0482) in patients with untreated advanced NSCLC. It's part of a larger research project exploring pembrolizumab treatments.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting various organs due to pembrolizumab and its combination drugs. Chemotherapy may cause nausea, fatigue, hair loss and increased risk of infection. Specific side effects depend on which investigational agent is used.

Eligibility Criteria

Inclusion Criteria

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

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My nonsquamous NSCLC is not eligible for approved targeted treatments.

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My lung cancer is confirmed to be stage IV.

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I haven't had systemic treatment for my metastatic NSCLC.

Exclusion Criteria

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

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I am allergic to carboplatin, paclitaxel, pemetrexed, or their ingredients.

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I have been diagnosed with small cell lung cancer.

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I am currently being treated for an infection.

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I had major surgery less than 3 weeks ago.

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I stopped immunotherapy due to a severe side effect.

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I have a history of Hepatitis B or an active Hepatitis C infection.

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I am on chemotherapy and have serious digestive system issues.

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I've had lung radiation over 30 Gray in the last 6 months.

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I have fluid buildup in my abdomen or around my lungs and am taking Alimta.

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I am taking medication that affects liver enzymes and can't stop during the study.

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I cannot or will not take folic acid or vitamin B12 supplements.

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I have cancer that has spread to my brain or spinal cord.

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I am taking medication that affects liver enzymes and cannot stop during the study.

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

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I have serious heart problems, including recent heart attacks or severe heart failure.

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

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have moderate nerve pain or tingling.

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I have another cancer that is getting worse or was treated in the last 2 years.

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I will not need any cancer treatment other than the study's while participating.

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I have been treated with immunotherapy targeting PD-1, PD-L1, or PD-L2.

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I have a known history of HIV.

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I have received chemotherapy or targeted therapy for my cancer after it spread.

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I have had or currently have lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at designated time points up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at designated time points up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at designated time points up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)

Part B: Number of Participants Who Experience One or More Adverse Events (AEs)

+1 more

Secondary study objectives

Part A: Number of Participants Who Discontinue Study Treatment Due to an AE

Part A: Number of Participants Who Experience One or More AEs

Part A: Progression-Free Survival (PFS) According to RECIST 1.1

+8 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

11Treatment groups

Experimental Treatment

Group I: Part B: Pembrolizumab + I-DXdExperimental Treatment2 Interventions

On Day 1 of each 3-week cycle, participants with squamous and nonsquamous NSCLC will receive pembrolizumab 200 mg IV for up to 2 years, PLUS I-DXd in escalating doses until progressive disease or toxicity.

Group II: Part B: Pembrolizumab + Carboplatin + I-DXdExperimental Treatment3 Interventions

On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS I-DXd IV in escalating doses until PD or toxicity.

Group III: Part B: Pembrolizumab + Carboplatin + HER3-DXdExperimental Treatment3 Interventions

On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS HER3-DXd IV in escalating doses until PD or toxicity.

Group IV: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group V: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group VI: Part A: Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group VII: Part A: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group VIII: Part A: Pembrolizumab+MK-0482+Carboplatin+PemetrexedExperimental Treatment3 Interventions

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group IX: Part A: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelExperimental Treatment3 Interventions

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).

Group X: Part A: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m\^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).

Group XI: Part A: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelExperimental Treatment4 Interventions

On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Boserolimab

2018

Completed Phase 1

~190