Phase II Study of Platinum (Cisplatin/Carboplatin)and Polymeric Micelles Paclitaxel(Pm-Pac) With Ivonescimab in First Line Metastatic Squamous NSCLC.

Sponsor
Jiangsu Cancer Institute & Hospital
Study ID
NCT07009925
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Squamous Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Ivonescimab 20mg/kg intravenous every 3 weeks — DRUG
    Ivonescimab(20mg/kg) combined with paclitaxel polymeric micelles (≤300mg/㎡) and platinum(cisplatin 75mg/㎡or carboplatin AUC5) IV every 3 weeks for 4 cycles.If patient assessment is of clinical benefit, maintenance therapy with ivonescimab or plus polymeric micelles paclitaxel(≤230mg/m\^2) can be continued based on investigator's evaluation and patient's own choice until disease progression or unacceptable toxicity. Ivonescimab is administered first, followed by paclitaxel polymeric micelles and platinum.The maximum treatment duration of ivonescimab and polymeric micelles paclitaxel is 24 months.

Study Details

This is a prospective, single-arm, multi-center, phase Ⅱ trial to evaluate the efficacy and safety of Polymeric Micelles paclitaxel(pm-Pac), platinum (cisplatin/carboplatin) in combination with Ivonescimab as first-line treatment in metastatic squamous NSCLC patients.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

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

Arms

  • Experimental: Ivonescimab 20mg/kg combined with polymeric micelles paclitaxel and platinum in squamous NSCLC

Primary Outcome Measure

progression-free survival [ Time Frame: From the start of treatment until disease progression or death (assessed up to 24 months) ]

Central Contacts

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