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

Sponsor
Sun Yat-sen University
Study ID
NCT03872661
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI308 — DRUG
    IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.
  • Bevacizumab — DRUG
    Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.
  • Pemetrexed — DRUG
    Pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.
  • Carboplatin — DRUG
    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.
  • Thoracic surgery — PROCEDURE
    Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Study Details

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.

Key Dates

First listed
Mar 13, 2019
Start date
Mar 1, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug and surgery
    Neoadjuvant therapy followed by surgery. Neoadjuvant therapy included four drugs. IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles; bevacizumab was administered at a dose of 15 mg/kg; pemetrexed was given 500 mg/m\^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles; 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. Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.

Primary Outcome Measure

Resectability rate [ Time Frame: 3 months ]

Central Contacts

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