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Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

NCT03802240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2023-11-27

No results posted yet for this study

Summary

The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Sintilimab

200mg IV Q3W

DRUG

IBI305

15mg/kg IV Q3W

DRUG

Pemetrexed

500mg/m2 IV Q3W

DRUG

Cisplatin

75mg/m2 IV Q3W

DRUG

Placebo1

Placebo1 IV Q3W

DRUG

Placebo2

Placebo2 IV Q3W

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2021-07-31
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802240 on ClinicalTrials.gov