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Combination Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer (NeoCOAST-2 Trial)

Phase 2
Recruiting
Led By Tina Cascone, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow function
Must not have
Active or uncontrolled infections including HBA, HBV, HCV, and HIV
Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new cancer treatment that uses two drugs, one to attack the cancer and one to boost the immune system. The goal is to see if this treatment is safe and effective.

Who is the study for?
This trial is for newly diagnosed NSCLC patients with resectable disease stages IIA-IIIB, who have good organ and bone marrow function, can provide recent tumor samples to check certain biomarkers, and have a performance status of 0 or 1. It excludes those with autoimmune disorders, prior cancer treatments, planned lung surgeries like pneumonectomy, EGFR mutations/ALK translocations, heart issues including QTcF ≥470 ms, previous immune therapy or specific ADCs use.
What is being tested?
The study tests the safety and effectiveness of perioperative treatment combining Durvalumab with Oleclumab/Monalizumab/AZD0171 plus platinum-based chemo; MEDI5752 plus platinum chemo; or Dato-DXd with Durvalumab and single-agent platinum chemo in early-stage NSCLC that can be surgically removed.
What are the potential side effects?
Potential side effects include reactions related to the immune system affecting organs (like inflammation), infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment-induced exhaustion, digestive problems such as nausea or diarrhea due to chemotherapy's effect on rapidly dividing cells including those in the gut lining.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My organs and bone marrow are working well.
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I have early-stage lung cancer that can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any active or uncontrolled infections.
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I am not currently on any cancer treatments like chemotherapy or hormone therapy.
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I do not have any severe ongoing illnesses that would interfere with the study.
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I have or had an autoimmune or inflammatory disorder.
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I have small-cell lung cancer or a mix of small-cell lung cancer.
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I have no health conditions that prevent me from receiving chemotherapy.
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I have had another type of cancer before.
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I have moderate or severe heart disease.
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My cancer has specific changes in the EGFR gene or ALK gene.
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I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5: AZD0171 + durvalumab + CTXExperimental Treatment5 Interventions
Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Group II: Arm 4: Dato-DXd + durvalumab + single agent platinumExperimental Treatment4 Interventions
Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin
Group III: Arm 3: Volrustomig (Dose Exploration) + CTXExperimental Treatment4 Interventions
Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Group IV: Arm 2: Monalizumab + Durvalumab + CTXExperimental Treatment5 Interventions
Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Group V: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)Experimental Treatment5 Interventions
Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840
Cisplatin
2013
Completed Phase 3
~2360
Pemetrexed/Carboplatin
2012
Completed Phase 3
~210
Carboplatin
2014
Completed Phase 3
~6120
Oleclumab
2015
Completed Phase 2
~880
Monalizumab
2019
Completed Phase 2
~250
Pemetrexed/Cisplatin
2012
Completed Phase 3
~210
Carboplatin/Paclitaxel
2005
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,319 Total Patients Enrolled
ParexelIndustry Sponsor
308 Previous Clinical Trials
100,661 Total Patients Enrolled
Tina Cascone, MDPrincipal InvestigatorMD Anderson Cancer Center Houston, TX 77030

Media Library

Durvalumab Clinical Trial Eligibility Overview. Trial Name: NCT05061550 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX), Arm 3: Volrustomig (Dose Exploration) + CTX, Arm 5: AZD0171 + durvalumab + CTX, Arm 4: Dato-DXd + durvalumab + single agent platinum, Arm 2: Monalizumab + Durvalumab + CTX
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05061550 — Phase 2
Durvalumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061550 — Phase 2
~327 spots leftby Dec 2029
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