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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

Summary

This trial is testing NC318, a new cancer drug, either alone or with another cancer drug, pembrolizumab, to see if it can treat advanced non-small cell lung cancer.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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 2
~2010

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,397 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,242 Total Patients Enrolled
NextCure, Inc.Industry Sponsor
6 Previous Clinical Trials
389 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
~34 spots leftby Jun 2025