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Recruiting NCT06607796

Efficacy and Safety of Intratumoral Toluenesulfonamide (PTS) Injection in Stage IV Driver Gene-Negative NSCLC With/Without Chemoimmunotherapy

Phase III Interventional 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: Toluenesulfonamide (PTS) Intratumoral Injection.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 18 years — 75 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
China
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 →

Official title

A Multicenter Study of the Efficacy and Safety of Intratumoral Injection of Toluenesulfonamide (PTS) in Combination With or Without First-line Chemoimmunotherapy Based on Standard Treatment for Stage IV Driver Gene-negative Non-small Cell Lung Cancer

Overview

The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.

Interventions

  • Drug Toluenesulfonamide (PTS) Intratumoral Injection
    intratumoral injection of toluenesulfonamide(PTS) to oligo lesions

Primary outcome measures

  • Objective response rate(ORR) [Time frame: 3 years]
Secondary outcome measures (2)
  • Median progression-free survival(mPFS) [Time frame: 3 years]
  • Median overall survival(mOS) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Fully understand, be informed about the study and sign the Informed Consent Form (ICF); be willing to follow and be capable of completing all trial procedures；
  • Age ≥18 years and ≤75 years at the time of signing the ICF；
  • Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
  • At least one measurable target lesion assessed by the investigator according to the requirements of RECIST 1.1 within 4 weeks prior to enrollment, except for lesions proposed for percutaneous PTS local injection；
  • Localized injectable lesions located in a more confined area of the outer lung bands, less than or equal to 5 cm in diameter; these may be primary lesions that are not amenable to surgical resection or localized recurrent lesions after surgical resection and radiotherapy treatment；
  • ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
  • Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
  • Life expectancy ≥ 3 months；
  • Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.

Exclusion criteria

  • Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
  • Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
  • Have severe bleeding, clotting disorders, infections, dehydration, etc;
  • Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
  • History of severe emphysema and pulmonary alveoli;
  • History of drug allergy or contraindication to toluene sulfonamide;
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
  • The investigators determined that the patients had other conditions that made them unsuitable 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
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT06607796 · CROC-24-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗