Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

Eligibility criteria

Qualifiers

Able to provide written informed consent form (ICF) and agree to follow study requirements and assessment schedule.

Aged 18 years or older.

Histologically confirmed stage I non - small cell lung cancer (AJCC 9th edition), with tumor size 2cm <= T <=4cm.

Postoperative pathological report shows at least one high-risk factor (visceral pleural invasion, lymphovascular invasion, STAS, poorly differentiated status, high-grade invasive adenocarcinoma (any structure + high grade structure >=20%, including solid, micropapillary, or complex glands)).

Disqualifiers

Any previous treatment for current lung cancer, including radiotherapy and systemic anti-tumour therapies (chemotherapy, immunotherapy, targeted therapy, anti-angiogenesis therapy, etc.).

Prior chest radiotherapy (including lung, oesophageal, mediastinal, or breast cancer).

Patients with large - cell neuroendocrine carcinoma (LCNEC) or mixed - subtype non - small - cell lung cancer with small - cell components.

With EGFR/ALK sensitive mutations.

Trial design

Treatments tested in this trial

  • Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group

Treatment groups

108 Participants
are divided into 2 treatment groups

Locations

1
Chinese Academy of Medical Sciences Cancer Hospital Beijing China

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor