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Clinical Trials List

Protocol NumberGO29438
NCT Number(ClinicalTrials.gov Identfier)NCT02657434

2016-07-01 - 2020-06-30

Phase III

Terminated9

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN + PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN + PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    F. Hoffmann-La Roche Ltd

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Inn-Wen Chong Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chao-Hua Chiu Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

3 Stop recruiting

Audit

None

Principal Investigator 簡志峰 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop 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 Stop recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 蘇茂昌 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Inn-Wen Chong 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator Han-Pin Kuo Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

NON-SMALL CELL LUNG CANCER (NSCLC)

Objectives

This study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab in combination with carboplatin or cisplatin + pemetrexed compared with carboplatin or cisplatin + pemetrexed in patients who are chemotherapy-naive and have Stage IV non-squamous non−small cell lung cancer (NSCLC). Specific objectives and corresponding endpoints for the study are outlined below.

Test Drug

Atezolizumab (MPDL3280A)

Active Ingredient

Atezolizumab (anti-PD-L1 antibody)

Dosage Form

IV

Dosage

1200mg/20 ml

Endpoints

To evaluate the efficacy of atezolizumab in the programmed death−ligand 1
(PD-L1)−selected population as measured by investigator-assessed PFS
according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST
v1.1) in atezolizumab + carboplatin + pemetrexed versus carboplatin +
pemetrexed.
• To evaluate the efficacy of atezolizumab in the intent-to-treat (ITT) population
as measured by investigator-assessed progression-free survival (PFS) according
to RECIST v1.1 in atezolizumab + carboplatin + pemetrexed versus carboplatin
+ pemetrexed.
• To evaluate the efficacy of atezolizumab in the PD-L1−selected population as
measured by investigator-assessed PFS according to RECIST v1.1 in
atezolizumab + carboplatin or cisplatin + pemetrexed versus carboplatin or
cisplatin (pooled) + pemetrexed.
• To evaluate the efficacy of atezolizumab in the ITT population as measured by
investigator-assessed PFS according to RECIST v1.1 in atezolizumab +
carboplatin or cisplatin + pemetrexed versus carboplatin or cisplatin (pooled) +
pemetrexed

Inclution Criteria

Patients must meet all of the following criteria to be eligible for study entry:
• Signed Informed Consent Form
• Male or female, 18 years of age or older
• ECOG performance status of 0 or 1
Histologically or cytologically confirmed, Stage IV non-squamous NSCLC (per
the Union Internationale contre le Cancer/American Joint Committee on
Cancer staging system, 7th edition; Detterbeck et al. 2009).
• No prior treatment for Stage IV non-squamous NSCLC
Patients with a sensitizing mutation in the epidermal growth factor receptor
(EGFR) gene are excluded given that erlotinib, gefitinib, or another EGFR
tyrosine kinase inhibitor (TKI) is the appropriate initial treatment of EGFR-mutant NSCLC.
Patients with an anaplastic lymphoma kinase (ALK) fusion are excluded given
that crizotinib or other ALK inhibitors is the appropriate initial treatment of
NSCLC in patients having an ALK fusion oncogene.
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or
chemoradiotherapy with curative intent for non-metastatic disease must have
experienced a treatment-free interval of at least 6 months from randomization since
the last chemotherapy or completion of chemoradiotherapy.

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study entry:
Cancer-Specific Exclusions
• Active or untreated CNS metastases as determined by CT or magnetic
resonance imaging (MRI) evaluation during screening and prior radiographic
assessments
• Spinal cord compression not definitively treated with surgery and/or radiation
or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to randomization
• Leptomeningeal disease
• Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable regimen at study entry.
Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or
metastases causing nerve impingement) should be treated prior to randomization.
Patients should be recovered from the effects of radiation. There is no required
minimum recovery period.
Asymptomatic metastatic lesions whose further growth would likely cause
functional deficits or intractable pain (e.g., epidural metastasis that is not currently
associated with spinal cord compression) should be considered for loco-regional
therapy, if appropriate, prior to randomization.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    568 participants

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