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Clinical Trials List

Protocol NumberD9077C00001
NCT Number(ClinicalTrials.gov Identfier)NCT05061550
Active

2023-03-31 - 2030-12-30

Phase II

Not yet recruiting5

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

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)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

Main test purpose Evaluating the anti-tumor activity of preoperative lead therapy from the perspective of pCR Assess the safety and tolerability of lead and adjuvant therapies Secondary test purpose Evaluate the efficacy of preoperative preoperative treatment and postoperative adjuvant treatment from the perspective of EFS Evaluate the efficacy of preoperative preoperative treatment and postoperative adjuvant treatment from the perspective of DFS (events are calculated from the time of surgery). Assessing the feasibility of scheduled tumor resection in patients receiving lead therapy Evaluating the anti-tumor activity of preoperative preoperative treatment from the perspective of MPR Evaluating the efficacy of preoperative preoperative treatment from the perspective of ORR Evaluating the efficacy of leading and adjuvant treatments from the perspective of OS Describe the PK of the investigational drug in patients receiving lead/adjuvant therapy Evaluating the immunogenicity of investigational drugs in patients receiving lead/adjuvant therapy To explore the PD L1 expression volume during the baseline period and its correlation with clinical trial indicators in patients receiving preemptive and adjuvant therapy. Assessing changes in ctDNA during lead treatment and association with clinical trial parameters in patients with evaluable ctDNA

Test Drug

Durvalumab InjectionOleclumab InjectionMonalizumab InjectionMEDI5752 InjectionDato-DXd InjectionAZD0171 Injection

Active Ingredient

Durvalumab
Oleclumab
Monalizumab
MEDI5752
Datopotamab Deruxtecan
AZD0171

Dosage Form

Concentrate for solution
Concentrate for solution
Lyophilised product for concentrate for solution
Lyophilised product for concentrate for solution
Lyophilised powder for concentrate for solution
Concentrate for solution

Dosage

50 mg/mL
50 mg/mL
375 mg
250 mg
100 mg
20 mg/mL

Endpoints

- pCR is defined as central BIPR determination that there are no viable tumor cells after thorough evaluation of the resected lung cancer specimen and all locally sampled lymph nodes as described in IASLC 2020 (Travis et al., 2020). The measurement item that the trial focuses on is the proportion of patients with 0% residual viable tumor cells in all resected tissues, as blindly assessed by central pathologists.
- Evaluate safety and tolerability from the perspective of AEs, vital signs and various clinical laboratory parameters.

Inclution 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

Exclusion Criteria:

Participants with sensitising EGFR mutations or ALK translocations.
Active or prior documented autoimmune or inflammatory disorders.
Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, 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.
History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
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, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
Active or uncontrolled infections including HBA, HBV, HCV, and HIV.

The Estimated Number of Participants

  • Taiwan

    19 participants

  • Global

    630 participants

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