Menu
Not yet recruiting NCT05891080

Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

Phase II Interventional Stage III Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toripalimab, JS004, Pemetrexed, Nab-paclitaxel.
Who it may be relevant to
Registry conditions: Stage III Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.

Interventions

  • Drug Toripalimab
    Specified dose on specified days.
  • Drug JS004
    Specified dose on specified days.
  • Drug Pemetrexed
    Specified dose on specified days.
  • Drug Nab-paclitaxel
    Specified dose on specified days.
  • Drug Carboplatin
    Specified dose on specified days.
  • Procedure Surgery
    Patients with resectable tumor after neoadjuvant therapy will be treated with surgery.

Primary outcome measures

  • Pathologic complete response (PCR) rate [Time frame: Up to 30 months]
Secondary outcome measures (9)
  • Objective response rate (ORR) [Time frame: up to 30 months]
  • Major pathologic response (MPR) rate [Time frame: Up to 30 months]
  • Treatment-related adverse event (TRAE) [Time frame: Up to 30 months]
  • Rate of conversion from potentially resectable to resectable [Time frame: Up to 30 months]
  • R0 resection rate [Time frame: Up to 30 months]
  • Event-free survival (EFS) [Time frame: up to 60 months]
  • Overall survival (OS) [Time frame: up to 60 months]
  • EORTC-QLQ-C30 scale [Time frame: up to 5 months]
  • EORTC-QLQ-L13 scale [Time frame: up to 5 months]

Eligibility criteria

Inclusion criteria

  • The patient shall sign the Informed Consent Form.
  • Aged 18 ≥ years.
  • Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
  • Life expectancy is at least 12 weeks.
  • At least 1 measurable lesion according to RECIST 1.1.
  • Patients with good function of other main organs (liver, kidney, blood system, etc.)
  • Patients with lung function can tolerate surgery;
  • Without systematic metastasis (including M1a, M1b and M1c);
  • Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
  • Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).

Exclusion criteria

  • 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;
  • Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
  • With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
  • Participants who are allergic to the test drug or any auxiliary materials;
  • Participants with Interstitial lung disease currently;
  • Participants with active hepatitis B, hepatitis C or HIV;
  • Pregnant or lactating women;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
  • Participated in another therapeutic clinical study;
  • Other factors that researchers think it is not suitable for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05891080 · LungMate-014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗