Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC(neoSCORE Ⅱ)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Eligibility criteria

Qualifiers

Sign the informed consent form before starting any trial related procedure.Be willingness and able to undergo planned visits, protocol therapy, laboratory tests and other testing procedures.

18-75 years old, male or female.

Squamous Cell Non-small cell lung cancer confirmed by cytology or histology.

There must be at least one evaluable focus judged according to recist1.1 standard.

Disqualifiers

Malignancies within 5 years prior to the first dose(excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of carcinoma in situ).

Currently participating in the intervention clinical treatment, or receiving other drugs or research instruments within 4 weeks before the first dose.

Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or drugs for another stimulation or synergistic inhibition of T cell receptor (e.g. CTLA-4, OX-40, CD137).

Active autoimmune diseases requiring systemic treatment (e.g. using disease improving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first dose. Alternative therapies (e.g. thyroxine, insulin or corticosteroids in physiological doses for adrenal or pituitary insufficiency) are not considered systemic treatment.

Trial design

Treatments tested in this trial

  • Sintilimab
  • Carboplatin
  • Albumin-Bound Paclitaxel

Treatment groups

250 Participants
are divided into 2 treatment groups