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Monoclonal Antibodies

NC318 + Pembrolizumab for Lung Cancer

Phase 2

Recruiting

Led By Scott Gettinger

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically documented, locally advanced or metastatic NSCLC

At least one tumor amenable to biopsy, and willingness to undergo tumor biopsy

Must not have

History of life-threatening toxicity related to prior anti-PD-1 axis therapy

No prior PD-1 axis inhibitor therapy (Arm 2a)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, NC318, alone or with Pembrolizumab, in patients with advanced lung cancer. It aims to help those who haven't responded to other treatments or have specific tumor characteristics. The drugs work by enhancing the immune system's ability to attack cancer cells.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer who have tried PD-1 axis inhibitor therapy and it didn't work (except Arm 2a). They should be relatively healthy, able to undergo a biopsy, and not have used immunosuppressive drugs recently. Those with certain gene mutations after treatment failure or intolerance are also eligible.

What is being tested?

The study is testing the effectiveness of NC318 at two different doses, either alone or combined with Pembrolizumab. It's designed to see how well these treatments can control lung cancer that has spread and isn't responding to previous therapies.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells in the body, infusion-related reactions from receiving drugs through a vein, fatigue, potential organ inflammation, 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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My lung cancer is advanced or has spread to other areas.

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I am willing to have a biopsy on at least one of my tumors.

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I have had PD-1 inhibitor therapy and my cancer progressed afterwards.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I had a severe reaction to previous immunotherapy.

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I have never received PD-1 axis inhibitor therapy.

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I had radiation therapy not targeting the brain within the last 2 weeks.

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I have brain metastases that are causing symptoms or have not been treated.

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I have had cancer spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor response will be based on tumor assessments at screening, every 8 weeks from the first dose (for the first 24 weeks) and thereafter every 12 weeks until investigator-assessed initial disease progression, up to 4 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

Number of participants in arm 2 with treatment related adverse events as assessed by CTCAE v5

Number of participants in arm 2a with treatment related adverse events as assessed by CTCAE v5

Number of participants on Arm 1b with treatment related adverse events as assessed by CTCAE v5

+6 more

Secondary study objectives

Overall Survival (RECIST v1.1) Arm 1a

Overall survival (RECIST v1.1) Arm 1B

Overall survival (RECIST v1.1) Arm 2

+3 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

5Treatment groups

Experimental Treatment

Group I: Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and PembrolizumabExperimental Treatment2 Interventions

Arm 2a will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive combination therapy with NC318 and pembrolizumab.

Group II: Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and PembrolizumabExperimental Treatment2 Interventions

Arm 2 will enroll patients with advanced NSCLC who are naïve to PD-1 axis inhibitor therapy to receive therapy with NC318 in combination with pembrolizumab.

Group III: Arm 1c - NC318 and PembrolizumabExperimental Treatment1 Intervention

At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab.

Group IV: Arm 1b - NC318 and PembrolizumabExperimental Treatment2 Interventions

At the discretion of the treating physician, advanced NSCLC patients on arm 1b will receive combination therapy with NC318 and pembrolizumab.

Group V: Arm 1a - NC318 onlyExperimental Treatment1 Intervention

At the discretion of the treating physician, advanced NSCLC patients on arm 1a will receive NC318 alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,930 Previous Clinical Trials

3,033,061 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,956 Previous Clinical Trials

41,112,230 Total Patients Enrolled

NextCure, Inc.Industry Sponsor

6 Previous Clinical Trials

467 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

4,031 Previous Clinical Trials

5,189,545 Total Patients Enrolled

Scott Gettinger3.58 ReviewsPrincipal Investigator - Yale University

Yale University

5Patient Review

Dr Gettinger is caring, intelligent, and competent. He takes the time to explain treatments, answer questions, and get input from patients about their care. He is also helpful if a second opinion is needed. I feel confident and relieved that he is my oncologist.