A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT04023617
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Docetaxel
  • Nivolumab

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w

Study Details

This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and Nivolumab in patients. Qualified patients were stratified by histological type (squamous cell carcinoma vs. non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio: Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6 weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After the 48th week of assessment, a tumor assessment is required every 9 weeks until disease progression, withdrawal of informed consent, sponsor termination study, or patient death.

Key Dates

Start date
Jul 8, 2019
Status verified
Jul 2019
Primary completion
Jun 30, 2020
Completion
May 30, 2021

Study Design

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

Arms

  • Experimental: Nivolumab + Docetaxel
    Nivolumab was administered at a dose of 300 mg on the first day of the 21-day cycle (every 3 weeks; q3w) when combined with docetaxel, and administered at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w) after stopping docetaxel treatment. On the first day of each cycle (21 days), docetaxel 75 mg/m2 was infused by IV on Day 1 of each 21-day cycle for 4-6 cycles (judged by investigator).
  • Active Comparator: Nivolumab
    Nivolumab was administered in the monotherapy group at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w).

Primary Outcome Measure

PFS [ Time Frame: 24 months ]

Central Contacts

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