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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 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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

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
~2810

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,916 Previous Clinical Trials
3,039,303 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,899 Previous Clinical Trials
41,014,006 Total Patients Enrolled
NextCure, Inc.Industry Sponsor
6 Previous Clinical Trials
467 Total Patients Enrolled

Media Library

NC318 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04699123 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab, Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab, Arm 1a - NC318 only, Arm 1b - NC318 and Pembrolizumab, Arm 1c - NC318 and Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: NC318 Highlights & Side Effects. Trial Name: NCT04699123 — Phase 2
NC318 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04699123 — Phase 2
~24 spots leftby Jun 2025
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