RecruitingPhase 2NCT03872661

Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC

A Multicenter Phase II Trial of Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Non-Small Cell Lung Cancer


Sponsor

Sun Yat-sen University

Enrollment

36 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to studying neoadjuvant IBI308, bevacizumab, plus pemetrexed and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining an immunotherapy drug (IBI308), a drug that cuts off blood supply to tumors (bevacizumab), and standard chemotherapy (pemetrexed and carboplatin) before surgery can shrink stage III non-small cell lung cancer enough to make it removable by surgery. **You may be eligible if...** - You have stage III non-small cell lung cancer that currently cannot be removed by surgery - You are 18–74 years old and in good general health - Your cancer does not have specific genetic mutations (EGFR or ALK) - You are able to perform most daily activities (ECOG 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have active autoimmune disease - You have uncontrolled infections or serious heart or lung conditions - You are pregnant or breastfeeding - You have previously received certain immunotherapy or targeted therapy drugs - You have already received radiation to the chest Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI308

IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.

DRUGBevacizumab

Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.

DRUGPemetrexed

Pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.

DRUGCarboplatin

Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.

PROCEDUREThoracic surgery

Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT03872661


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