QL1706 Plus Anlotinib as a Later-line Treatment for Patients With Advanced Lung Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07636226
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    Every 3 weeks, 5mg/kg of QL1706 is administered intravenously until the disease progresses.
  • Anlotinib — DRUG
    10mg Anlotinib is administered orally. It is given daily for the first 14 days, then stopped for 7 days. A 3-week period constitutes one cycle, and this process continues until the disease progresses.

Study Details

This is a multicenter, open-label, randomized controlled phase II/III study evaluating the efficacy and safety of QL1706 in combination with anlotinib as later-line treatment in patients with advanced lung cancer.

Key Dates

First listed
Jun 9, 2026
Start date
Jul 30, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

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

Arms

  • Experimental: cohort 1
    Cohort 1 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past.
  • Active Comparator: cohort 2
    Cohort 2 includes patients with advanced SCLC who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past.
  • Experimental: cohort 3
    Cohort 3 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past.
  • Active Comparator: cohort 4
    Cohort 4 includes patients with advanced lung squamous cell carcinoma who have received at least 2 lines of treatment but no more than 3 lines of treatment in the past.

Primary Outcome Measure

OS [ Time Frame: From date of first study treatment to date of death from any cause, assessed up to approximately 36 months ]

Central Contacts

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