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

Zhou Chengzhi

Status and phase: Enrolling; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Toluenesulfonamide (PTS) Intratumoral Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06607796

CROC-24-09

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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；
2. Age ≥18 years and ≤75 years at the time of signing the ICF；
3. Histologically or cytologically confirmed stage IV (AJCC 8th edition) driver gene negative non-small cell lung cancer；
4. 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；
5. 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；
6. ECOG PS score of 0 or 1 within 7 days prior to local treatment tolerates PTS intratumoral injections；
7. Patients with localized lesions present and persistently stable (SD evaluated after two courses of treatment) after standard treatment with first-line chemoimmunotherapy；
8. Life expectancy ≥ 3 months；
9. Normal liver, kidney and heart function, normal blood routine, blood biochemistry, coagulation function and electrolytes and other physiological indicators.

Exclusion criteria

1. Plans for radiotherapy, surgery, etc. for the lesion after intratumor injection;
2. Have severe cardiopulmonary dysfunction, advanced hepatic or renal insufficiency, malignant cardiac arrhythmia, hypertension, etc;
3. Have severe bleeding, clotting disorders, infections, dehydration, etc;
4. Have blood disorders, autoimmune diseases, cirrhosis of the liver, etc;
5. History of severe emphysema and pulmonary alveoli;
6. History of drug allergy or contraindication to toluene sulfonamide;
7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
8. The investigators determined that the patients had other conditions that made them unsuitable for enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Experimental group

Experimental group

Description:

intratumoral injection of toluenesulfonamide (PTS) to oligo lesions

Treatment:

Drug: Toluenesulfonamide (PTS) Intratumoral Injection

Control subjects

No Intervention group

Description:

follow-up observation of oligofocal lesions, no PTS intratumoral injection treatment, if progression can be oligofocal PTS intratumoral injection