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Platinum-containing Compounds

Chemo/Immunotherapy for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Thomas Lycan, Jr., D.O., M.H.S.

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

At least 18 years old

Patients must have normal organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL

Must not have

Known to have an active autoimmune disease that required systemic treatment in the past 2 years

History of (non-infectious) pneumonitis that required systemic corticosteroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to end of 4th cycle of treatment (12 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing how well two groups of cancer patients respond to immunotherapy. One group has cancer that is not as advanced, and the other group has cancer that is more advanced. The goal is to show that the group with more advanced cancer does just as well as the other group when treated with immunotherapy.

Who is the study for?

This trial is for adults with non-small cell lung cancer that's metastatic or can't be surgically removed, and who haven't had chemo or immunotherapy before. They should have a life expectancy over 3 months, normal organ/marrow function, and no history of certain conditions like pneumonitis treated with steroids.

What is being tested?

The study tests if patients with lower performance status (weaker condition) do as well on first-line immunotherapy-based treatments as those in better condition. It involves drugs like Pembrolizumab and chemotherapy agents, along with quality of life assessments.

What are the potential side effects?

Possible side effects include immune-related reactions due to Pembrolizumab, such as inflammation in organs; chemotherapy may cause fatigue, nausea, low blood counts increasing infection risk. Quality of life questionnaires assess the impact.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My blood tests show normal white blood cell and platelet counts.

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My lung cancer cannot be removed by surgery and has no cure with standard treatments.

Exclusion Criteria

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

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I have an autoimmune disease treated within the last 2 years.

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I have had lung inflammation treated with steroids.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My lung cancer has a specific mutation that requires targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to end of 4th cycle of treatment (12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to end of 4th cycle of treatment (12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of 4th cycle of treatment (12 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Participants with Progression-Free Survival

Secondary study objectives

Change in Overall Quality of Life/Global Health Status - EORTC QLQ-C30

Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events

Proportion of Participants with Deterioration in Symptoms - QLQ-LC13

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

2Treatment groups

Experimental Treatment

Group I: Performance Status 2 ParticipantsExperimental Treatment8 Interventions

ALL study participants will receive pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle. Participants with predictive biomarker PD-L1 greater than or equal to 50%: Participants will not receive any other drugs besides pembrolizumab. Participants with Non-squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will ALSO receive: - Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS - Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. Participants with Squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will also receive: * Carboplatin AUC 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS * Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. OR * Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles

Group II: Performance Status 0-1 ParticipantsExperimental Treatment8 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Nab paclitaxel

2014

Completed Phase 2