Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.

Male or female aged ≥18 years at the time of signing the ICF.

Histologically or cytologically confirmed stage II-IIIB (N2) non-squamous non-small cell lung cancer (NSCLC) (AJCC 8th edition).

With Known KRAS gene mutation.

Disqualifiers

Previously received any treatment for the current lung cancer, including radiotherapy and all systemic anti-tumor treatments, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy.

Presence of locally advanced, unresectable disease, regardless of disease stage or presence of metastases.

Received other approved systemic immunomodulatory agents (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymosin α1, and thymalfasin) within 4 weeks prior to the first dose.

Used any herbal medicine to control cancer within 14 days prior to the first dose of the study drug.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    administered via Intravenous (IV) injection

  • Cisplatin

    Drug

    administered via IV infusion

  • Carboplatin

    Drug

    administered via IV infusion

  • Pemetrexed Disodium

    Drug

    administered via IV infusion

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Tislelizumab plus platinum doublet chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate

Time frame
Up to 3 months following completion of neoadjuvant treatment

Secondary outcomes

1

Major pathological response (MPR) rate

Time frame
Up to 3 months following completion of neoadjuvant treatment
2

Objective Response Rate (ORR)

Time frame
Up to 3 years
3

Event-free survival (EFS)

Time frame
Up to 3 years
4

Overall survival (OS)

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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