A multicentre, open-label, randomized Phase III Study of Atezolizumab with Platinum-Pemetrexed with or without Bevacizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer (WJOG11218L Investigator-Initiated Clinical Trial)

JRCT ID: jRCT2080224500

Registered date:07/01/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 23/01/2019
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : atezolizumab
INN of investigational material : atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 1200 mg as an IV infusion once every 21 days
Generic name etc : bevacizumab
INN of investigational material : bevacizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 15 mg/kg as an IV infusion once every 21 days
Generic name etc : carboplatin
INN of investigational material : carboplatin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : AUC 5 as an IV infusion once every 21 days
Generic name etc : pemetrexed
INN of investigational material : pemetrexed
Therapeutic category code : 422 Antimetabolic agents
Dosage and Administration for Investigational material : 500mg/m2 as an IV infusion once every 21 days

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy
Progression free survival (PFS) by central assessment
PFS will be assessed according to RECIST version 1.1.

Secondary Outcome

safety
efficacy
Investigator-assessed PFS, overall survival (OS), investigator-assessed overall response rate (ORR), investigator assessed duration of response (DOR) and safety
PFS, ORR and DOR will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with a histologically or cytologically confirmed diagnosis of non-squamous NSCLC
2. Patients who have the results of EGFR mutation test
3. Patients with stage III and stage IV NSCLC not treatable with radical radiotherapy or postoperative recurrent NSCLC
4. Patients with tumor lesion, regardless of with or without measurable lesion as defined by the RECIST version 1.1
5. Absence of symptomatic brain metastasis
6. Patients who were not previously treated with chemotherapy, in the patients confirmed to be positive-mutation in any driver gene, need previously treatment by appropriate TKI
7. ECOG PS 0 or 1

Exclude criteria

1.Patients with active other cancers except for NSCLC
2.Patients with a past or current history of hemoptysis
3.Presence of a bleeding tendency
4.Patients with an interstitial lung disease evident on CT scans
5.Hypertension uncontrollable with standard drug therapy
6.Patients with hypersensitivity to the ingredients or additives of carboplatin, pemetrexed, atezolizumab or bevacizumab
7.Pregnant women, lactating women, women who may be pregnant at present or patients not intending to practice contraception

Related Information

• Primary Sponsor: Isamu Okamoto (Coordinating Investigator)
• Secondary Sponsor: -
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd
• Secondary ID(s): JapicCTI-194565