Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC

Phase 3

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Atezolizumab(Tecentriq); Drug: Pemetrexed; Drug: Carboplatin or cisplatin; Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT03991403
• Lead Sponsor: Samsung Medical Center

Brief Summary

This randomized, Phase III, multicenter, open-label study designed to evaluate the efficacy of Atezolizumab in combination with carboplatin, paclitaxel, bevacizumab compared with treatment with pemetrexed, cisplatin in approximately 228 TKI(tyrosine kinase inhibitor) pre treated patients with Stage IV non squamous non small cell lung cancer with activating EGFR mutation or ALK translocation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-08-27
• Status Verified: 2023-03
• Primary Completion: 2023-03-11
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-04-03
• Study Completion: 2024-03-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atezolizumab group	Atezolizumab(Tecentriq)	-
Control group	Carboplatin or cisplatin	-
Atezolizumab group	Carboplatin	-
Atezolizumab group	Paclitaxel	-
Atezolizumab group	Bevacizumab	-
Control group	Pemetrexed	-

Primary Outcome Measures

Name	Time	Method
progression-free survival, PFS	34month after the first patient is randomized	To evaluate the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab as progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECIST v1.1) in the following treatment:Atezolizumab + carboplatin + paclitaxel + bevacizumab versus Pemetrexed + carboplatin or cisplatin

Secondary Outcome Measures

Name	Time	Method
overall survival(OS)	24month after the last patient is randomized
objective response rate(ORR)	24month after the last patient is randomized
duration of response(DOR)	24month after the last patient is randomized

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnamgu, Korea, Republic of