Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.

Eligibility criteria

Qualifiers

The patient shall sign the informed consent.

Age ≥ 18 years.

Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).

No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose.

Disqualifiers

Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.

Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/day) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (<7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions;

Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.

Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.

Trial design

Treatments tested in this trial

  • sintilimab+IBI310+chemotherapy

Treatment groups

54 Participants
are divided into 1 treatment group