Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

Eligibility criteria

Qualifiers

The patient shall sign the Informed Consent Form.

Aged 18 ≥ years.

Histological or cytological diagnosis of NSCLC by needle biopsy, and stage III confirmed by imageological examinations (CT, PET-CT or EBUS).

Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.

Disqualifiers

Non-squamous cell carcinoma with EGFR active mutation positive or ALK rearrangement;

Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;

Administration of any Chinese medicine against cancer before administration of the drug;

Participants with other cancer (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;

Trial design

Treatments tested in this trial

  • Sintilimab
  • Chemotherapy

Treatment groups

100 Participants
are divided into 2 treatment groups