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Trial record 1 of 1 for:    neocoast2
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Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2)

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ClinicalTrials.gov Identifier: NCT05061550
Recruitment Status : Recruiting
First Posted : September 29, 2021
Last Update Posted : December 20, 2022
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab or Monalizumab and platinum doublet chemotherapy; or MEDI5752 in combination with platinum doublet chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Durvalumab Drug: Oleclumab Drug: Monalizumab Drug: MEDI5752 Drug: Carboplatin/Paclitaxel Drug: Pemetrexed/Cisplatin Drug: Pemetrexed/Carboplatin Phase 2

Detailed Description:

This is a open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.

Arm 1: Participants will receive Oleclumab + durvalumab + platinum doublet chemotherapy as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.

Arm 2: Participants will receive Monalizumab + durvalumab + platinum doublet chemotherapy as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.

Arm 3: Participants will receive MEDI5752 + platinum doublet chemotherapy as neoadjuvant treatment and MEDI5752 as adjuvant treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
Actual Study Start Date : April 14, 2022
Estimated Primary Completion Date : March 30, 2026
Estimated Study Completion Date : March 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Oleclumab + Durvalumab + Platinum doublet chemotherapy

Participants will receive Durvalumab + Oleclumab + platinum doublet chemotherapy 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

Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI

Drug: Oleclumab
Participants will receive Oleclumab via intravenous route.
Other Name: MEDI9447

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy

Experimental: Monalizumab + Durvalumab + Platinum doublet chemotherapy

Participants will receive Durvalumab + Monalizumab + platinum doublet chemotherapy 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

Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI

Drug: Monalizumab
Participants will receive Monalizumab via intravenous route.
Other Name: IPH2201

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy

Experimental: MEDI5752 + Platinum doublet chemotherapy

Participants will receive MEDI5752 + platinum doublet chemotherapy as neoadjuvant treatment and MEDI5752 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

Drug: MEDI5752
Participants will receive MEDI5752 via intravenous route.

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as chemotherapy

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin as chemotherapy




Primary Outcome Measures :
  1. Number of participants with pathological complete response (pCR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
  2. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Until Day 90 after the last dose of study interventions (Up to approximately 3 years) ]

Secondary Outcome Measures :
  1. Number of participants experiencing an event-free survival (EFS) event [ Time Frame: Up to approximately 3 years ]
  2. Number of participants experiencing a disease-free survival (DFS) event [ Time Frame: Up to approximately 3 years ]
  3. Number of participants having surgical resection [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
  4. Number of participants with major pathological response (mPR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
  5. Number of participants with Objective response rate (ORR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
  6. Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
  7. Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/MEDI5752) [ Time Frame: From randomization to last dose of study interventions (Up to approximately 3 Years) ]
  8. Number of participants with anti-study drug antibodies (ADA) [ Time Frame: From randomization to 3 months after last dose of study interventions (Up to approximately 3 Years) ]
  9. Baseline PD-L1 expression [ Time Frame: At Screening/ baseline ]
  10. Changes in circulating tumour DNA (ctDNA) [ Time Frame: From randomization to up to 24 months after last dose of study interventions (Up to approximately 3 Years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
  • WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ and bone marrow function.
  • Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
  • Adequate pulmonary function.

Exclusion Criteria:

  • Participants with sensitising EGFR mutations or ALK translocations.
  • History of allogeneic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders.
  • Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
  • History of another primary malignancy.
  • Participants with small-cell lung cancer or mixed small-cell lung cancer.
  • History of active primary immunodeficiency.
  • Participants who have preoperative radiotherapy treatment as part of their care plan.
  • Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
  • QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
  • Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
  • Participants with moderate or severe cardiovascular disease.
  • Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
  • Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A and HLA-E agents are also excluded.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061550


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Show Show 62 study locations
Sponsors and Collaborators
AstraZeneca
Parexel
Investigators
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Principal Investigator: Tina Cascone, MD MD Anderson Cancer Center Houston, TX 77030
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05061550    
Other Study ID Numbers: D9077C00001
2021-003369-37 ( EudraCT Number )
First Posted: September 29, 2021    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Lung Cancer
early-stage
Durvalumab
Oleclumab
Monalizumab
Neoadjuvant
Adjuvant
Chemotherapy
MEDI5752
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Durvalumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological