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Clinical Trials List

Protocol NumberBO39610

NCT Number(ClinicalTrials.gov Identfier)NCT03337698

2021-01-15 - 2028-12-31

Phase I/II

Not yet recruiting1

Recruiting1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)

Trial Applicant

COVANCE TAIWAN SERVICES LIMITED
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Yuh-Min Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

Heng-Sheng Chao 未分科
Yung-Hung Luo 未分科
Yuan-Hung Wu 未分科
Chi-Lu Chiang 未分科
Hsu-ching Huang 未分科

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wu-Chou Su 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small-Cell Lung

Objectives

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: the first-line (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms

Test Drug

Tecentriq
Avastin
Docetaxel Accord
Ipatasertib
Trajenta
Sacituzumab Govitecan

Active Ingredient

Atezolizumab
Bevacizumab
Docetaxel
Ipatasertib
Linagliptin
Sacituzumab Govitecan

Dosage Form

Solution for Infusion
Solution for Infusion
Solution for Infusion
Film-coated tablet
Film-coated tablet
lyophilizate for solution for infusion

Dosage

60mg/ml
25mg/ml
20mg/ml
100mg
5mg
180mg

Endpoints

Percentage of Participants with Objective Response.

Inclution Criteria

1.Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
2.Life expectancy greater than or equal to 3 months
3.Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
4.Measurable disease (at least one target lesion)
5.Adequate hematologic and end-organ function
6.Tumor accessible for biopsy
7.Availability of peripheral blood for next-generation sequencing (NGS) circulating tumor deoxyribonucleic acid (ctDNA) testing.
8.For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
9.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

- Inclusion Criteria for Cohort 1
1.No prior systemic therapy for metastatic NSCLC
2.High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) >= 50%
- Inclusion Criteria for Cohort 2
1.Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC

Exclusion Criteria

1.Prior allogeneic stem cell or solid organ transplantation
2.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
3.Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
4.History of leptomeningeal disease
5.Active or history of autoimmune disease or immune deficiency
6.History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
7.History of malignancy other than NSCLC within 2 years prior to screening
8.Active tuberculosis
9.Severe infection within 4 weeks prior to initiation of study treatment

The Estimated Number of Participants

Taiwan

30 participants
Global

435 participants