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

ConditionLung Cancer (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

    Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

2 year disease-free survival rate, 2y-DFS rate

Time frame
From the start of randomization to two years later

Secondary outcomes

1

disease-free survival, DFS

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
2

overall survival, OS

Time frame
From date of randomization until the date of death from any cause, assessed up to 60 months
3

Number of Participants with Adverse Events as Assessed by CTCAE v5.0

Time frame
From enrollment to the end of systemic anti-tumor treatment at 30 days (90 days for recording irAE )

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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