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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
NeoCOAST-2 Trial 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.Check my eligibility
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.See study design
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.
NeoCOAST-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My organs and bone marrow are working well.
Select...
I have early-stage lung cancer that can be surgically removed.
NeoCOAST-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
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 with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with pathological complete response (pCR)
Secondary outcome measures
Baseline PD-L1 expression
Changes in circulating tumour DNA (ctDNA)
Number of participants experiencing a disease-free survival (DFS) event
+7 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
NeoCOAST-2 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
Carboplatin
2014
Completed Phase 3
~6670
Oleclumab
2015
Completed Phase 2
~880
Durvalumab
2017
Completed Phase 2
~3870
Monalizumab
2019
Completed Phase 2
~250
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed/Cisplatin
2012
Completed Phase 3
~210
Pemetrexed/Carboplatin
2012
Completed Phase 3
~210
Carboplatin/Paclitaxel
2005
Completed Phase 3
~340
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,491 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,336 Total Patients Enrolled
Tina Cascone, MDPrincipal InvestigatorMD Anderson Cancer Center Houston, TX 77030
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any active or uncontrolled infections.I am scheduled for radiotherapy before surgery as part of my treatment plan.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I am fully active or can carry out light work.My organs and bone marrow are working well.I have not been treated with specific immune therapies or certain antibody drugs.I can provide recent (≤ 6 months old) tumor samples for PD-L1, EGFR, or ALK status testing.I might need surgery to remove my lung cancer.I do not have any severe ongoing illnesses that would interfere with the study.I have or had an autoimmune or inflammatory disorder.I have small-cell lung cancer or a mix of small-cell lung cancer.I have no health conditions that prevent me from receiving chemotherapy.I have had another type of cancer before.I have moderate or severe heart disease.My cancer has specific changes in the EGFR gene or ALK gene.I have not received a live vaccine in the last 30 days.I have not taken immunosuppressive drugs in the last 14 days.I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.I have early-stage lung cancer that can be surgically removed.My lungs are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 5: AZD0171 + durvalumab + CTX
- Group 2: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
- Group 3: Arm 3: Volrustomig (Dose Exploration) + CTX
- Group 4: Arm 4: Dato-DXd + durvalumab + single agent platinum
- Group 5: Arm 2: Monalizumab + Durvalumab + CTX
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what purpose is Durvalumab most often put?
"Durvalumab has potential in the treatment of unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and other advanced directives."
Answered by AI
How many hospitals in this city are conducting this research?
"Currently, this trial is being conducted at 14 sites in locations including Gainesville, Saint Louis Park and Fairfax. To reduce the burden of travel for participants, it is best to select a site that is geographically close."
Answered by AI
How many individuals are signed up to take part in this experiment?
"That is correct, the clinical trial mentioned is recruiting patients as of now. The study was first posted on 4/14/2022 and updated last on 10/31/2022. There are a total of 210 participants needed to be recruited from 14 locations."
Answered by AI
Has Durvalumab undergone the FDA's approval process?
"While Phase 2 trials have not yet yielded data supporting efficacy, there is enough evidence of Durvalumab's safety to merit a score of 2."
Answered by AI
How can I sign up to take part in this experiment?
"The criteria for this study requires that patients have non-small-cell lung carcinoma and are between 18 to 130 years old. This trial is looking to enroll 210 individuals in total."
Answered by AI
Are there any other drugs that have been tested in similar ways to Durvalumab?
"There are a total of 341 clinical trials for Durvalumab with 52 of them being Phase 3. However, most these trials (13112) are based in Cordoba, Texas."
Answered by AI
Can adolescents participate in this research study?
"The age limit for this study is 18 years or older and 130 years or younger."
Answered by AI
Are patients currently being accepted for this treatment program?
"That is accurate. The information available on clinicaltrials.gov shows that this particular trial is still recruiting patients. This specific study was posted on April 14th, 2022 and updated on October 31st, 2022. There are 210 total spots for participants at 14 different locations."
Answered by AI
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