A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT05487391
Phase
PHASE3
Status
Recruiting
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Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QL1706 injection — DRUG
    QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy
  • Vinorelbine Tartrate — DRUG
    Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles
  • Paclitaxel — DRUG
    Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles
  • Cisplatin — DRUG
    Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles
  • Carboplatin — DRUG
    Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles
  • Pemetrexed — DRUG
    Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles
  • Placebo — DRUG
    Placebo

Study Details

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.

Key Dates

Start date
Dec 8, 2022
Status verified
Oct 2024
Primary completion
Aug 31, 2027
Completion
May 22, 2029

Study Design

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

Arms

  • Experimental: QL1706 plus Platinum-based chemotherapy
    QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy
  • Placebo Comparator: Placebo plus Platinum-based chemotherapy
    Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy

Primary Outcome Measure

Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. [ Time Frame: Up to approximately 84 months ]

Central Contacts

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