Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable NSCLC

Sponsor
Tang-Du Hospital
Study ID
NCT04338620
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small-cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • camrelizumab、albumin-bound paclitaxel and platinum — DRUG
    Experimental Group：camrelizumab、albumin-bound paclitaxel and platinum. Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin
  • albumin-bound paclitaxel and platinum — DRUG
    Control group：albumin-bound paclitaxel and platinum. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin

Study Details

Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.

Key Dates

Start date
Apr 7, 2020
Status verified
Mar 2023
Primary completion
Nov 30, 2023
Completion
Nov 1, 2023

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Experimental Group
    Participants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.
  • Active Comparator: B: Control group
    Participants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles.

Primary Outcome Measure

pathological complete response (pCR) [ Time Frame: The day of the surgery ]

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